WO2024002499A1

WO2024002499A1 - System and computer program product for assisting alleviating overactive bladder syndrome and incontinence symptoms

Info

Publication number: WO2024002499A1
Application number: PCT/EP2022/068298
Authority: WO
Original assignee: Dr Pfleger Arzneimittel GmbH
Current assignee: Dr Pfleger Arzneimittel GmbH
Priority date: 2022-07-01
Filing date: 2022-07-01
Publication date: 2024-01-04
Anticipated expiration: 2025-01-01
Also published as: EP4548359A1

Abstract

The present invention relates to a system and a corresponding computer program product for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, in particular at least one of reduction of micturitions and reduction of urine loss, comprising a liquid volume tracking component, a coffee tracking component, a medication tracking component, a pelvic floor exercises component for providing pelvic floor exercises to the user and tracking an intended execution, a bladder training component for providing bladder training exercises to the user and tracking an intended execution, and an adherence evaluation component for self-monitoring. The combination of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, the bladder training component and the adherence evaluation component is effective to reduce the number of micturitions of the user using the system. The invention also relates to a medicament for treating or preventing overactive bladder syndrome and incontinence symptoms.

Description

System and computer program product for assisting alleviating overactive bladder syndrome and incontinence symptoms

The present invention relates to a system and a corresponding computer program product for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, in particular at least one of reduction of micturitions and reduction of urine loss. The system is, without being limited, particularly suitable for being implemented and distributed as a smartphone app which may be operated by the user.

Background

The overactive bladder syndrome (OAB) includes the symptoms: urinary urge, pollakiuria and nocturia with or without urge incontinence. There must be no local, metabolic, underlying neurological or endocrine pathology [Abrams et al. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation

Subcommittee of the International Continence Society. Neurourol Urodyn 2002; 21: 167- 78].

OAB is the name for a group of urinary symptoms. Some people will leak urine when they feel this urge. The most common symptom of OAB is a sudden, imperative need to urinate. Imperative urination means sudden, without warning beginning urinary urge, with this the risk of urinary leakage comes along. A further symptom is pollakiuria, which means to pass urine many times during the day with normal amount of urine. A variety of pollakiuria is nocturia, which means being awakened by the urinary urge in the night [Klinger et al. Leitlinie: Die uberaktive Blase. Journal fur Urologie und Urogynakologie 2009; 16 (2) (Ausgabe fur Osterreich), 8-13], OAB is basically the urge to frequent, partially preventive and sometimes urgent toilet visits.

Leaking urine is called “incontinence”. Stress urinary incontinence (SUI), is another common bladder problem. Stress urinary incontinence (SUI) is a complaint of involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing. Mixed urinary incontinence (MUI) are complaints of both stress and urgency urinary incontinence, that is, involuntary loss of urine associated with urgency as well as with effort or physical exertion including sporting activities or on sneezing or coughing (stress) [D'Ancona et al. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn 2019 38(2): 433-477], Often, the true causes of bladder problems cannot unambiguously be identified.

Known diagnosis and therapies of the bevor mentioned diseases include performing a bladder diary. However, such voiding diaries are considered invaluable in the assessment of patients presenting with OAB symptoms, corroborating symptom severity, estimating functional bladder capacity and identifying those with polyuria [Osman and Chapple. Overactive bladder syndrome: Current pathophysiological concepts and therapeutic approaches. Arab J Urol. 2013 Dec;11(4):313-8. doi: 10.1016/j. aju.2013.07.006. Epub 2013 Sep 18], Thus, the initial diagnosis often includes a pad test in which a diaper/pad is used to objectify and quantify the loss of urine, especially with regard to the course of therapy. This is done most simply by the difference in the weight of the wet diapers/pads for a day or night from the dry weight of the same number of diapers and pads [Wiedemann et al. Harninkontinenz bei geriatrischen Patienten: Medikamentose Therapie [Urinary incontinence in geriatric patients: pharmacological Therapy]. Aktuelle Urol. 2019 Aug;50(4):424-440],

Furthermore, validated questionnaires are considered the primary tool for the evaluation of symptom severity and impact upon quality of life. It is considered vital to use such questionnaires in the initial assessment and monitoring response to treatment [Osman and Chapple. Overactive bladder syndrome: Current pathophysiological concepts and therapeutic approaches. Arab J Urol. 2013 Dec;11(4):313-8. doi:

10.1016/j. aju.2013.07.006. Epub 2013 Sep 18], E.g. ICIQ-UI or ICIQ-OAB questionnaires track when and how much fluid the user drinks; how often and how much the user urinates; how often the user has the urgency feeling; when and how much urine the user may leak. According to Osman and Chapelle (2013) treatment approaches in OAB progress from lifestyle measurements, behavioural and physical therapies towards pharmacotherapies through to minimally invasive treatments such as intradetrusor botulinum toxin and neuromodulation, with very few patients requiring more invasive procedures such as bladder augmentation. Lifestyle interventions, behavioural and physical therapies are considered the first line treatment:

Bladder training (or bladder drill) is recommended in the urinary incontinence treatment guidelines as first-line therapy to patients with urinary urge incontinence and mixed urinary incontinence. In practice it is also used for patients with urgency and frequency but no incontinence. It involves following a scheduled program aimed at improving an individual’s control over lower urinary tract function by progressively increasing the intervals between voids (using distraction or urgency suppression techniques) as well as modifying adverse drinking habits. The process is facilitated by the use of a bladder diary. Advise on medication, fluid intake and the consideration of reduction of caffeine intake are further interventions, which are suitable to improve OAB.

Pelvic floor muscle training (PFMT) has established efficacy in the treatment of SUI and MUI and it is recommended that patients are offered supervised PFMT for at least 3 months. In the context of urinary urge incontinence the aim of PFMT is to result in an improvement in urge suppression through potentiating of the guarding reflex. A systematic review of 13 trials concluded that physiotherapy techniques may be beneficial for the treatment of urinary urge incontinence although the data is considered limited and further studies are required [Greer JA, Smith AL, Arya LA. Pelvic floor muscle training for urgency urinary incontinence in women: a systematic review. Int. Urogynecol. J. 23(6), 687-697 (2012)].

Summary of the invention

In view of the above, it was therefore an object of the present invention to provide a system for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, which changes the user’s behaviour in a medically significant way.

In a first aspect, a system for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, in particular at least one of reduction of micturitions and reduction of urine loss, is provided. The system comprises a liquid volume tracking component for tracking a liquid intake of the user; a coffee tracking component for tracking a coffee intake of the user; a medication tracking component for tracking a medication adherence ofthe user; a pelvic floor exercises component for providing pelvic floor exercises to the user and tracking an intended execution; a bladder training component for providing bladder training exercises to the user and tracking an intended execution, and an adherence evaluation component for selfmonitoring. The adherence evaluation component is configured to obtain an adherence score value from each of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, and the bladder training component, and to obtain an overall adherence result of the user based on the obtained adherence score values. In addition, the daily number of micturitions and the felt urge are tracked for self-monitoring in context of adherence scores.

The present invention is based on the result of scientific research, which identifies five core pillars for the behavioural therapy of OAB or other bladder problems. These core pillars include tracking or monitoring liquid intake, e.g. water, coffee intake, and adherence to (prescribed) medication intake. In further preferred embodiments, other tracking components may also be integrated, such as a micturition tracker or a classical bladder protocol, which can further improve the system. Respective studies, however, revealed that liquid, e.g. water, and coffee intake most significantly influence the bladder conditions.

The systematic research further revealed that education for motivation as well as physical and mental training of the user are further core pillars of the behavioural therapy. The present invention therefore includes two components that address the training aspect. First, the user is provided with pelvic floor exercises to strengthen the pelvic floor muscles, i.e., a physical training of the pelvic floor, affecting both muscles and nervous system. Second, the user is provided with bladder training exercises, which address the psychological aspects of the urge and systematically distract the mind from being influenced by the urge feeling.

The final and combining pillar is the engagement ofthe user to both the tracking and training components. It has been shown that most important for the effectiveness of a behavioural therapy is that the user understands, accepts and then adheres to the therapy to efficiently adapt the new behaviour, changes daily routines and sustainably integrates it into a new routine. To this end, the present invention provides the adherence evaluation component, which combines the five pillars and provides the user with an overall adherence to his/her therapy. Thus, the present invention effectively links the individually contributing factors with the adherence evaluation component and improves the overall effectiveness of the therapy as scientifically proven by the results of the systematic study.

The derived adherence score is therefore an efficient and simple way of self-monitoring the progress of the therapy by the user, using a simple graphical display of the score value.

The adherence evaluation component is in this context part of the overall engagement concept, which in preferred embodiments includes additional factors as will be described below.

In a second aspect system for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user is presented, the alleviation being expressed as a reduction in tracked daily micturitions over the course of using the system, the system comprising a liquid volume tracking component for tracking a liquid intake of the user, a coffee tracking component for tracking a coffee intake of the user, a medication tracking component for tracking a medication adherence of the user, a pelvic floor exercises component for providing pelvic floor exercises to the user and tracking an intended execution, a bladder training component for providing bladder training exercises to the user and tracking an intended execution, and an adherence evaluation component, wherein the combination of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, the bladder training component and the adherence evaluation component is effective to reduce the number of micturitions of the user using the system.

Thus, the components of the system according to the present invention allow to statistically significantly reduce the number of micturitions of patients/users by comparing the number of micturitions at the beginning of using the system and after a certain period of using the system, for instance after 4 or for 12 weeks.

In a preferred embodiment the alleviation of overactive bladder syndrome symptoms of the user using the system can be determined by at least one of a list of secondary outcomes. The secondary oucomes include: a change in the mean amount of urine loss in grams as measured by a 1 hour PAD test according to Krhut et al. 2014 from baseline, i.e. visit 1 , to 4 weeks to 12 weeks, i.e. visit 2; a change in the overall score of the quality-of-life questionnaire ICIQ-OABqol* from baseline to 4 weeks, to 12 weeks; a change in the total score of the questionnaire ICIQ-OAB from baseline to 4 weeks, to 12 weeks; a change in the total score of the questionnaire ICIQ-UI-SF from baseline to 4 weeks, to 12 weeks; a change in the mean number of PADs used per day from baseline to 4 weeks, to 12 weeks using a 3-day bladder protocol; a change in the mean intensity of urge expressed as a score ranging preferably from 0 to 4 from baseline to 4 weeks, to 12 weeks using a 3-day bladder protocol; a change in the frequency of the use of an urge button per day during whole study period; a change in the mean intensity of urge via urge button expressed as a score ranging preferably from 0 to 4 during whole study period; a change in the mean number of micturitions per day during whole study; changes in the mean number of micturitions during the day, preferably between 6 a.m. - 10 p.m., using a 3-day bladder protocol; changes in the mean number of micturitions during the day preferably between 6 a.m. - 10 p.m., during whole study; changes in the mean number of micturitions during night, preferably between 10 p.m. -6 a.m., using a 3-day bladder protocol; changes in the mean number of micturitions during night, preferably between 10 p.m. -6 a.m., during whole study; changes in the mean number of urine leakage per day using a 3-day bladder protocol; changes in the mean urine volume (ml) per micturition using a 3-day bladder protocol; changes in the mean drinking volume (ml) per day; changes in the mean caffeine consumption per day; changes in the mean number of executed bladder trainings per day; execution of pelvic floor exercises as recommended; changes in the frequency and continuity of using the system; and completeness of documented intake of prescribed medication.

In a preferred embodiment the system comprises a progress report component, the progress report component comprising an adherence report subcomponent being configured to generate a single interface for reporting the individual adherence score values and the obtained overall adherence result to the user.

The single interface which is configured to present the user with his/her adherence score values provides a simple to understand form of understanding the progress of his/her therapy to the non-medically qualified user.

In a preferred embodiment the adherence report subcomponent is configured to encode at least one of the individual adherence score values and the overall adherence result as circular segments, a higher adherence corresponding to a larger circular segment. The circular segments provide a visually easily perceivable form of understanding the information of the overall adherence result. For example, the adherence may be determined as a value ranging from 0%, meaning no adherence, to 100%, meaning full adherence, wherein the length of the circular segment may then correspond to the adherence as a fraction of the complete circle. For example, the circle may be complete for full adherence and not present for no adherence.

In a preferred embodiment the adherence report subcomponent is configured to encode the overall adherence result as concentric circular segments of the individual adherence score values.

The concentric circular segments allow to perceive in the same representation the adherence to the individual pillars or components identified as relevant to the user’s therapy.

In a preferred embodiment one, several or all of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, the bladder training component, and the adherence evaluation component are implemented as functional modules of a smartphone app.

The smartphone app may be downloadable from an application store, executable by the user on the smartphone, and capable of being executed in an online and/or offline mode. The smartphone app may further communicate with components implemented on a cloud service. In other embodiments, one, several or all of the components may also be implemented as software running on a server and accessible remotely by a smartphone and/or a desktop browser.

In a preferred embodiment the system further comprises a download report component, the download report component being configured to generate at least one of a doctor report, a user data export report, and a bladder protocol for the user.

Compared to previous known solutions, the doctor report generated by the download report component may comprise additional information relevant for the doctor’s assessment, such as the other medications, a patient may consume, or the result of a bowel movement questionnaire. Thus, the doctor’s follow-on therapy, for instance medication prescription, may be more accurately adapted to the user’s individual case. The report for the doctor is a by-product of the primary intended purpose of the invention, providing additional medical value for the patient in regard to their further medication and therapy plan.

In a preferred embodiment the download report component is configured to provide the user with an email notification including a link for downloading the report, the link having an expiration period.

The email address may be stored in user preferences, the report may then be generated based on entering credentials on the web page and/or by activating report generation in app. Thus, the report generation and availability for instance on a desktop or laptop computer is facilitated. In the alternative, the report may be available as a direct download in the app.

In a preferred embodiment the system further comprises an onboarding component, the onboarding component being configured to register a user and collect data from the user for the operation of further components of the system, including collecting data on prescribed medications for overactive bladder syndrome treatment for the medication tracking component, special dietary requirements regarding drinking volume and coffee consumption for the liquid volume tracking component and the coffee tracking component, and assessment data based on the ICIQ-UI-SF questionnaire.

The onboarding component can preferentially rely on other components such as a questionnaire component described below for gathering the data of the ICIQ-UI-SF questionnaire. The onboarding component allows to register the user and adapt the further therapy to the individual case and needs of the particular user.

In a preferred embodiment the liquid volume tracking component, the coffee tracking component, and the medication tracking component are configured to operate based on the tracked values being provided by user input.

In this embodiment, no external sensors or the like are required such that the complexity of the system can be reduced. In alternative embodiments, external sensors may additionally be user such that the contribution by the user may be reduced.

In a preferred embodiment at least one of the liquid volume tracking component, the coffee tracking component, and the medication tracking component are configured to send a notification to the user requesting user input to the tracker. The notification is part of the overall engagement concept, which addresses the finding that the user’s engagement to providing data to the tracker may deteriorate over time. To counteract the user’s reduction of engagement, recurrent notifications or reminders may be provided in addition to rewards and other aspects of the overall engagement concept as will be described below.

In a preferred embodiment the system comprises an urge component, the urge component being configured to be activated by the user using a dedicated urge button on a home screen of an application.

The urge component is designed to be activated by the user in case he/she experiences the need to urinate. It preferentially may be activated by a prominently placed button on a home screen of the app. Thus, the user may activate the urge component quickly in case he/she feels the urge. The urge component is directed to assist the user in relieving a momentary need or urinary urge. To this end, the urge component employs specially selected mental games provided by the bladder training component that activate certain brain regions which “overlap” the brain signals indicating the urinary urge. Thereby, the user’s need to urinate may be reduced and the urge to go to the toilet immediately will be delayed, leading to a strengthening of the bladder capacity over time.

In a preferred embodiment the urge component is configured to track the user’s urge level and provide the bladder training component with the tracked urge level.

Preferentially, the bladder training component can then select the adequate training out of a plurality of trainings according to the tracked urge level. For instance, in case a high level of urgency is provided by the user based on the ICIQ-UI-SF questionnaire, a different recommended length for the bladder training, e.g., 10 min, will be presented than if the user has an overall lower urge level. The individual urge value and the recommended bladder training is required to measure individual adherence scores, e.g. someone with 10 min training goal, receives 50 % if they manage 5 min of withstanding the urge by performing exercises/games etc.

In a preferred embodiment the system further comprises a questionnaire component, the questionnaire component being configured to present a questionnaire to the user and record the user’s responses to one or more questions contained in the questionnaire. In a preferred embodiment the questionnaire component is configured to present at least one of the questionnaires: during a user onboarding process; and in preparation to a doctor visit. In some modifications, at least one of the questionnaires is presented on a regular basis.

In a preferred embodiment the questionnaires presented by the questionnaire component comprising at least one of: an onboarding questionnaire for general medical assessment; an urge level questionnaire; a before interim doctor visit questionnaire; a before follow-up doctor visit questionnaire; a quality of life questionnaire; an after interim doctor visit questionnaire; an ICIQ-UI-SF questionnaire; a bowel movement assessment questionnaire; a feedback questionnaire

While the individual questionnaires, such as the ICIQ-UI-SF questionnaire, are known in an analogue format, it is a significant improvement of the present invention to include the various different questionnaires, typically employed in clinical studies, into the same component, in particular the same mobile smartphone app environment for home use. Thus, the record of the user’s responses to the presented different questionnaires allows to record a complete picture of the user from different perspectives.

In a preferred embodiment the questionnaire component is configured to provide previously completed questionnaires to the users, wherein the questionnaire component preferentially allows user’s review, comparison and/or editing of previously completed questionnaires.

Preferentially, questionnaires are only editable for a predefined number of days after submitting the questionnaires such that later modification which might alter the medical conclusion or diagnosis are avoided.

In a preferred embodiment the system further comprises a standardized tests component, the standardized tests component being configured to assist the user in completing standardized tests, in particular at least one of an urine loss pad test and a bladder protocol test. Different from the questionnaire, in which the user is requested to provide answers to questions, the standardized tests include exercises which the user has to perform on his/her body. The standardized tests component is configured to provide an interface which supports the user in performing these tests, for instance by providing instructions, motivation and/or reminders to the user.

In a preferred embodiment the standardized test component is therefore configured to generate one or more interfaces allowing the user to: review how to take the standardized test; answer all questions of the standardized test; submit responses to the standardized test; and allow finishing the test later, in particular in cases where the test assumes data captured for several days as for the bladder protocol.

In a preferred embodiment the system the standardized test component is configured to provide previously completed tests to the users, wherein the standardized test component preferentially allows user’s review, comparison and/or editing of previously completed tests.

Preferentially, similar to questionnaires, tests are only editable for a predefined number of days after submitting the test results.

In a preferred embodiment the system further comprises a notification component for notifying the user, the notification component implementing at least one of, preferably all of, in-app notifications, reminder notifications, and email notifications based on notification types.

The various types of notifications may comprise different priorities, such that the user can distinguish between notifications of rather informative character and notifications with higher priority, such as medication intake reminders.

In a preferred embodiment the system further comprises an engagement component, the engagement component being configured to support the user in alleviating incontinence symptoms, wherein the engagement component comprises at least one of a segmentation and positioning subcomponent, a reward subcomponent, and a digital companion mascot subcomponent providing event- and rule-based suggestions, reminders, instructions and engaging emotional facial expressions. The engagement component spans over the entire system and is the result of significant research by the inventors of the present invention. The plurality of different aspects forming part of the engagement concept result in a sufficiently frequent and correct utilization of the app, which is proven as a result of the systematic study. The increase of the user’s engagement and adherence to the recommendations is shown to increase the effectiveness and the medical effect of the behavioural therapy.

In a preferred embodiment the engagement component comprises the segmentation and positioning subcomponent, the segmentation and positioning subcomponent being configured to generate a segmentation over a plurality of users with regard to the overall adherence score and to classify the obtained overall adherence result of the user with the generated segmentation.

It is therefore possible to evaluate, by the user, his/her performance compared to a specific control group of other users, for instance users of the same age and/or sex. Preferentially, the segmentation and positioning subcomponent is configured to provide motivational notices irrespective of the classification of the overall adherence score.

In a preferred embodiment the segmentation and positioning subcomponent is configured to generate the segmentation with regard to age groups of users and for each week of using the system.

For instance, five classes of adherence, e.g. 0-20%, 21-40%, etc., may be distinguished and the users may be grouped into groups spanning, for instance, 10 years of age. Of course, also other classifications may be used.

The data of the other users may be stored online in a cloud, wherein the segmentation and positioning subcomponent may then obtain the relative positioning of the user with regard to the other users of the system by communicating with the cloud.

In a preferred embodiment the engagement component comprises the animated mascot subcomponent, the animated mascot subcomponent being configured to indicate the user’s behaviour such as whether the user is doing good in terms of tracking data, adherence, and/or exercises, using emotions of an animated mascot presented to the user.

In a preferred embodiment the engagement component comprises the reward subcomponent, the reward subcomponent comprising a reward earning and a reward spending function, the reward earning function being configured to award reward to the user for providing data, in particular for entering data to at least one of the liquid volume tracking component, the coffee tracking component, and the medication tracking component, wherein the amount of reward increases with consecutive adherence to providing data by the user, the reward spending function being configured to donate a monetary amount to a selectable entity, in particular a charity organization, in accordance with the amount of reward awarded to the user.

Reward may for instance be stars for continuous utilization of the app according to the intended purpose of changing behaviour.

In a preferred embodiment the progress report component further comprising a position report subcomponent being configured to generated an interface indicating the user’s position relative to a relevant control group of users based on the generated segmentation and the classified overall adherence result by the segmentation and positioning subcomponent.

In a preferred embodiment the medication tracking component is configured to track user intake of one or more medications comprising an active substance selected from the list consisting of: trospium chloride, solifenacin, propiverine, mirabegron, oxybutynin, duloxetine, fesoterodine, desfesoterodine, tolterodine, darifenacin, desmopressin, imipramine, cucurbita pepo L., botulinum toxin, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin, ephedrine, phenylpropanolamine, midodrine, ascorbic acid, flavoxate, causticum hahnemanni, plantago major, vaccinium macrocarpon, populus tremuloides.

In a preferred embodiment the pelvic floor exercises component is configured to provide the user with a course of pelvic floor trainings, the course consisting of different phases depending on the time after first usage of the user, wherein the content provided to the user is adapted according to the current phase of the course.

The presentation of the pelvic floor exercises therefore differs depending on the experience the user has with the course. Thus, it can be avoided that unexperienced users are presented with complicated exercises that would require experience and, at the same time, the program stays attractive - also upon experience - and provides more and more effective training in regard to intensity, variability and length. In a preferred embodiment the advancing of phases is dependent on the user’s completion of required trainings.

In a preferred embodiment the phases include, in order, a base phase, a strength phase, an endurance phase, and a strength and endurance phase, wherein preferably the base phase is separated into a first part taking place from day 1 to day 3 and a second part taking place from day 4 to day 7, the strength phase takes place from day 8 to 28, the endurance phase takes place from day 29 to 49, and the strength and endurance phase takes place from day 50 to 84, wherein the length of the phases is a minimum duration and is adjusted appropriately dependent on the user’s completion of required trainings. The phases are schematically and exemplarily illustrated in Fig. 132.

Preferentially, an introductory check-in phase, i.e. and explanatory video, is integrated before starting with the base phase, which may be presented at the first time of using the pelvic floor exercises.

In a preferred embodiment the first part of the base phase includes presenting a first content, a second content and a third content to the user directed at supporting the user to feeling their pelvic floor muscles and learning how to contract them, the second part of the base phase includes presenting the second content, the third content and a fourth content to the user, the strength phase includes presenting a fifth content, a sixth content, and a seventh content to the user directed at supporting the user to strengthen the pelvic floor muscles, the endurance phase includes presenting an eighth content, a ninth content, and a tenth content to the user, and the strength and endurance phase includes presenting, in accordance with a user selection, one of the second content, the fifth content, the eighth content, and an eleventh content, presenting, in accordance with a user selection, one of the fourth content, the sixth content, the ninth content, and a twelfth content, and presenting, in accordance with a user selection, one of the seventh content, the tenth content, and a thirteenth content to the user.

The selection of and form of presentation of the first to thirteenth content as well as the specific phases of presenting the content throughout the course is selected in accordance with results of scientific evaluation of the pelvic floor training. Core insights that are integrated into the system according to the present invention are selection of the specific exercises and timing of the specific exercises.

In a preferred embodiment one, more or all of the first to thirteenth content is video content explaining specific pelvic floor training exercises, wherein the first and second content and the third and fourth content relate to the same pelvic floor training exercise, respectively.

In a preferred embodiment the pelvic floor exercises component includes, after presentation of content, a notification instructing the user of performing the exercise described in the presented content as a training.

In a preferred embodiment the pelvic floor exercises component determines that the daily training is completed if two exercises are performed by the user, wherein in particular the pelvic floor exercises component in the strength and endurance phase determines that the daily training is completed, if two extended trainings consisting of completing the training two times in a row are performed at least twice per week.

In a preferred embodiment the adherence evaluation component is configured to determine the adherence score from the pelvic floor exercises component based on the history of days with completed training.

In a preferred embodiment the pelvic floor exercises are grouped according to a) lying exercises, b) sitting exercises, and c) standing exercises; and according to i) breathing exercises, ii) power exercises, iii) endurance exercises, and iv) freestyle exercises.

In a preferred embodiment the bladder training component is configured to provide intervention exercises to the user for supporting the user to overcome sudden urinary urge.

As mentioned above, in a preferred embodiment the bladder training component presents an interface to the user in response to the user’s pressing of an urge button on a home screen of an app.

In a preferred embodiment the bladder training component is configured to provide at least one of the following exercises to the user: a memory game (“memorize”), a breathing/meditation exercise (“meditate”), a muscle tension exercise, a visual game (“find”), a geometric game (“sort”), and a runner game (“fly”).

In a preferred embodiment the bladder training component is configured to present the ful list of selectable exercises but provide a target time for playing, depending on the tracked urge level.

In a preferred embodiment the runner game is designed to educate the user subconsciously by incentivizing favourable behaviour and penalizing unfavourable behaviour in regard to their recommended behavioural change, in particular by penalizing coffee symbol collection and by incentivizing a meditation symbol collection.

In a preferred embodiment the system is configured to correlate liquid consumption, caffeine containing drinks consumption, and micturition over time in a single diagram to demonstrate the impact of the system on alleviating incontinence symptoms of a user.

In a further aspect the present invention provides a computer program product, in particular smartphone app downloadable via the Internet, implementing the system according to the first aspect of a preferred embodiment thereof.

In a further aspect the present invention provides a medicament comprising or consisting of an active substance selected from the list consisting of: trospium chloride, solifenacin, propiverine, mirabegron, oxybutynin, duloxetine, fesoterodine, desfesoterodine, tolterodine, darifenacin, desmopressin, imipramine, cucurbita pepo L., botulinum toxin, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin, ephedrine, phenylpropanolamine, midodrine, ascorbic acid, flavoxate, causticum hahnemanni, plantago major, vaccinium macrocarpon, popu-lus tremuloides for use in a method fortreating or preventing overactive bladder syndrome and incontinence symptoms of a patient, in particular at least one of reduction of micturitions and reduction of urine loss. The method comprises, in addition to administering said medicament, using the system or the computer program product according to an aspect or a preferred embodiment of the present invention.

Such treatment or prevention method is particularly advantageous as will be apparent from the herein described effect of the present invention. Further advantages and specific embodiments of the system and computer program product according to the present invention are described with reference to the enclosed drawings, which show:

Fig. 1 schematically and exemplarily illustrates the system according to the present disclosure;

Fig. 2 schematically and exemplarily illustrates functional modules of the system depicted in Fig. 1.

Figs. 3-129 schematically and exemplarily illustrate screens of a user interface generated by the system of Fig. 1 and 2.

Fig. 130 summarizes the engagement concept resulting in the combinatory technical and medical effect.

Fig. 131 summarizes the clinical study for showing the medical effect of the present invention.

Fig. 132 summarizes the four phases of the pelvic floor training.

Fig. 1 schematically and exemplarily illustrates a system 1 for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user 3. The system 1 and corresponding computer program product of the present disclosure are also referred to as “INKA” (Abrreviation for German: “Inkontinenz App”) and provide incontinence treatment support via two main parts: mobile application 10 and server side components 20.

INKA provides a detailed onboarding, tracking, and monitoring program that serves as a personalized input for:

Tailored Recommendations (e.g. fluid and caffeine intake regulation);

Bladder Training (e.g. cognitive deflection in cases of urge);

Behaviour;

Pelvic Floor Exercises (for strengthening the pelvic floor);

Compliance Reminders (e.g. medication adherence);

Educational Content (e.g. easy-to-understand videos to causes of OAB and certain behaviour alleviating OAB symptoms). The mobile application 10 generates user interfaces on a mobile device 2 such as a smartphone, and the like. The mobile application 10 may also be accessed by the user 3 via a browser or other software on a tablet, a personal computer, a smart TV, etc. The mobile application 10 is characterized by enabling the exchange of information with the user 3 using input and output interfaces.

The mobile application 10 collects data about various conditions of the user 3 via different trackers and questionnaires, after that it provides recommendations and educational materials (articles, videos and training exercises) to help with incontinence treatment as will be detailed below. Using mobile application 10, the user 3 could receive recommendations being both online or offline.

The server side components 20 are implemented in, for instance, a cloud computing service 4. The server side components 20 helps to manage and organize the treatment process. They centralize necessary content to deliver it to the mobile application 10, collect patient data of a plurality of users 3 for further analytics support and performs necessary integration to make the INKA solution of the present disclosure a part of national healthcare, for instance.

The following abbreviations are helpful in the context of the present disclosure:

API Application Programming Interface

Application/App INKA Mobile Application, is the mobile DiGA application that runs on a

Mobile Device.

CMS Content Management System.

DiGA Digital health applications (DiGA - in German: “Digitale Gesundheitsanwendungen”) is a CE-marked medical device.

ICIQ International Consultation on Incontinence Questionnaire (www.iciq.net).

Mobile device The user's smartphone or tablet that is used to run the Mobile Application.

OAB Overactive Bladder Syndrome.

OS Operating System.

PHI Protected Health Information.

Pll Personal Identifiable Information.

QoL Quality of Life. Registration code The code which provided by SHI and used to either register a new user account or renew subscription for existing user accounts.

SHI Statutory Health Insurance.

System The composition of user’s mobile device, INKA mobile application, and the server application, working together.

Ul Urine Incontinence.

User The person to whom INKA application has been prescribed and who uses the application.

The present disclosure relates to the treatment of different diagnosed conditions, i.e. to users or patients suffering from:

Pure OAB - Dry patients Patients who have OAB diagnosis and who do not loose urine.

Pure OAB - Wet patients Patients who have OAB diagnosis and also experience unintentional loss of urine (urgency incontinence).

Mixed OAB - Wet patients Patients who have OAB and also have stress incontinence, i.e. experience loss of urine during physical movement or activity.

The patient group is identified during the onboarding process using preferentially the ICIQ- UI-SF questionnaire, wherein each group is associated with specific answers to the questionnaire.

Fig. 2 schematically and exemplarily illustrates various functional components of the system 1 . Each of the functional components may be partly or completely implemented as part of the mobile application 10 and the server side components 20. Thus, each of the components may be implemented as part of the mobile application 10 or the server side components 20, only. Additionally or alternatively, each component may be implemented partly as both the mobile application 10 and the server side components 20.

The system 1 comprises a liquid volume tracking component 110, a coffee tracking component 120, a medication tracking component 130, a pelvic floor exercises component 140, a bladder training component 150, an adherence evaluation component 160, a progress report component 170, a download report component 180, an onboarding component 190, an urge component 200, a questionnaire component 210, a standardized test component 220, a notification component 230, and an engagement component 240. A possible implementation of a user end application, which implements the functionality of the system according to the present disclosure, will be described in the following. The user interfaces will then be related with the functional components 100-240 of the system 1 described above. It should be understood that, for instance, other interfaces may likewise be provided for the same functional components.

Tracking

The tracking functionality of the application allows users to manually submit the information about their micturition, urge, liquid consumption, and prescribed medications. Gathering and representing this important information will assist users in understanding of their progress in the treatment.

In particular, the application includes a medication tracker, a micturition tracker, a drink tracker, an urge assessment tracker, and a bladder sensation tracker, which each has its own questions) and data entry. The user can select the tracker from a list and provide data in the tracker, which is then stored and preferentially sent to the system’s backend. Each tracker may be selectable by the user from a home page or a different screen of the application.

The user can see the history of the trackers and review or fix past tracking data. The data ma be represented using a calendar where the user can select today’s date or any date in the past and see the actual data tracked in the trackers. The calendar shows how diligent the patient was at specific date in the past: did they fill all trackers or missed some of them.

The medication tracker allows the user to track a number of medications related to their urinary incontinence issues, which needs to be set up in the first place. The application notifies the user about time to take medications. The user can track medications for today and over a predefined number of days in the past only. The medication tracker is provided by the medication tracking component 130, which also stores the tracked data. Examples of interfaces illustrating the medication tracker are shown, for instance, in Fig. 79.

The following actions are available to the user: Select a check boxto track which medication has been taken; Unselect check box in case of mistake. The provided medication tracking data is stored by the system. The urge assessment tracker is initiated every time when the user wants to start intervention exercise. Preferentially, the urge assessment tracker is initiated as a result to the user’s pressing of an urge button located on the home screen of the app. The tracker registers date and time when the user has filled the tracker. Preferentially, the user may select the urgency state out of the following or different options: No urgency; Mild urgency; Moderate urgency; Severe urgency; Urge incontinence. Examples of interfaces illustrating the urge assessment tracker are shown, for instance, in Fig. 123.

The micturition tracker requests the user to input the number of times he/she went to the toilet. It is preferentially filled out two times per day by the user, wherein a notification for filling in the micturition tracker may be send to the user. The micturition tracker is preferentially disabled when the bladder protocol is active. The application in this case may automatically fill the micturition tracker with the data from the bladder protocol. Alternatively or additonally, the micturition tracker may be filled with data manually. Examples of interfaces illustrating the micturition tracker are shown, for instance, in Fig. 19.

The drink tracker preferentially includes the functionality of tracking both, liquid intake and coffee intake. It allows the user to select any value of liquid intake, for instance in ml with 50 ml step, and it allows the user to specify caffeine containing drinks intake, for instance within a range of 0 to 20 cups. It is preferentially filled two times per day, wherein notifications may be sent to the user. The drink tracker is provided by the liquid volume tracking component 110 and the coffee tracking component 120, which also store the tracked data. Examples of interfaces illustrating the drink tracker are shown, for instance, in Figs. 18, 20.

Fig. 3 schematically and exemplarily illustrates a first screen 300, which may be part of the onboarding process generated by the onboarding component 190 after a user initially starts the INKA application. A multimedia content 302 may be activated or the onboarding process may be started via a button 304.

Upon pressing button 304, the onboarding process may proceed with screen 310 as exemplarily illustrated in Fig. 4. Therein, the user can enter his or her personal data in input fields 312, before proceeding to the next step with button 314.

Fig. 5 schematically illustrates the next step of the onboarding process generated by onboarding component 190, namely medical questions screen 320. The user may decide whether he or she has actually prescribed medications for overactive bladder syndrome treatment. Pressing Yes 322 leads to setting up the medication tracker as will be described below, answering No 324 proceeds the onboarding to screen 330 as illustrated in Fig. 6.

If the user has a special dietary requirement regarding drinking volume and coffee consumption, pressing Yes 332 will direct the user to modifying the liquid volume tracking and coffee tracking settings as will be described below, wherein pressing No 334 will result in the standard settings for the liquid volume tracking and the coffee tracking. Pressing Yes 332 will lead to screen 340 as exemplarily illustrated in Fig. 7. The user is informed about the consequences of special dietary requirements and can proceed the onboarding process by pressing Next button 342.

Fig. 8 illustrates the next step of the onboarding process, i.e., screen 350. Screen 350 allows to set up notifications which are sent to the user in the morning, at noon, and in the evening. The time at which the respective notifications are sent can be adjusted on screen 350 by the user. The selection is confirmed by pressing Next 352.

It is possible that the application requests permissions to send notifications. In this case, following a user’s selection of Next 352, a request for permission screen 360 as illustrated in Fig. 9 may be presented.

If the user declines to enable notifications, an informative screen 370 as illustrated in Fig. 10 may be presented as part of the onboarding process. In this screen 370, it is explained why notifications are essential for the success of the treatment.

If notifications are allowed on screen 360 or button 372 is pressed, the onboarding process continues with screen 380 illustrated in Fig. 11 . The user is asked whether he or she has a scheduled next doctor visit or not. By pressing Yes 382, the doctor visit can be further specified on screen 390 as illustrated in Fig. 12. More specifically, date and time of the scheduled doctor visit can be provided in input fields 392. By pressing Next 394, the onboarding process may be completed. In other examples, different additional onboarding screens may be presented. In particular, onboarding questionnaires as will be detailed below may be presented to the user.

If no doctor visit is scheduled, by pressing button No 384 in screen 380, the onboarding process can also be completed. Fig. 13 illustrates a screen 400 in which Dr. Pfleger can be called by telephone. This screen 400 can be presented to the user as a result to the user’s contact selection in the main menu or based on specific input presented by the user. Screen 400 allows, through button 402, to directly call the hotline using the user’s mobile phone.

The onboarding component 190, which is responsible for generating screens 300 to 400, for instance, provides a plurality of further components with relevant data for the operation of the application. Those include the liquid volume tracking component 110, the coffee tracking component 120, the medication tracking component 130 and the notification component 230.

Next, the setting up of the medication tracker, on which medication tracking component 130 relies, is illustrated with reference to Fig. 14 to Fig. 18. The medication tracker can be configured as part of the onboarding process or at a later stage, for instance, through a settings menu activated by the user.

Fig. 14 illustrates screen 410, which is the initial screen for setting up the medication tracker. It may be presented as a result to the user pressing button Yes 322 in screen 320 or, as mentioned, by selecting the respective option in a menu of the application. In screen 410, no tracked medication is specified yet, by pressing button 412, a medication can be added.

Two examples of a screen 420 for adding a medication to the medication tracker are illustrated in Fig. 15 and Fig. 16. In both cases, the user can specify the name of the respective medication in input field 422 and the respective dose of medication in field 424. The user can select when to take the medication using control elements 426, wherein in the example of Fig. 15 the user selected three times per day and in Fig. 16 the user selected two times per day. The exact time of taking the medicine, for instance, in which notifications are presented, can be specified in a screen corresponding to screen 350 illustrated in Fig. 8. In input field 428, the prescribing doctor can be specified, before a button 430 can be used to save the tracked medication.

Fig. 17 illustrates screen 410, i.e., the medication tracker overview, in a filled state. In this example, two prescribed medications, namely oxybutin and tolterodine, are specified. Using a button 412, the user can save the entered data for the medication tracker. Fig. 18 specifically and exemplarily illustrates a screen 430 for providing data to the liquid volume tracking component 110. Using a selection component 432, the user can specify the liquid volume accurately. In the alternative, the user can also select out of a choice of prespecified drinking sizes ranging, for example, from 100 ml to 1 I using input 434. Using a Save button 436, the volume consumed by the user can be saved.

Fig. 19 schematically and exemplarily illustrates a screen 440, with which today’s micturitions can be specified and tracked. The user can select the amount of micturitions using the interface 442 and save the input using button 444.

Fig. 20 schematically and exemplarily illustrates a screen 454 providing the coffee intake by the user to the coffee tracking component 120. Likewise as with the drinking water, the user can specify the amount of today’s coffee cups using input selector 452 or adding a consumed coffee using the interface 454. Using the button 456, the user input can be saved.

Figs. 21 to 26 illustrate the process of providing the user with a bladder protocol. In Fig. 21 , the initial screen 460 for setting up the bladder protocol is presented. The test takes three days and it is passed two times, at the beginning of treatment and before a doctor’s visit. The data provided to the bladder protocol will be made available to the doctor and thereby help to track the process. First, an educative content, for instance, a video 462 explaining the bladder protocol, can be viewed, before the bladder protocol is started by pressing button 464.

By pressing button 464, the user is transferred to screen 470 as illustrated in Fig. 22, in which the user is asked whether he or she uses incontinence aids. Answering in the affirmative by pressing Yes 472 will lead to screen 480 as illustrated in Fig. 23, while pressing No 474 leads the user directly to screen 490 in Fig. 24.

In screen 480, the user can specify what incontinence aids he or she uses. In particular, the user can select a product using selector 482 and the respective corresponding absorbency using selector 484 before proceeding with Next button 486 to screen 490.

Fig. 24 illustrates screen 490 which presents the interface to the actual bladder protocol to the user. Every time the user urinated, he or she is requested to press the Urinated button 492 and note the amount of urine, which may, for example, be collected in a measuring cup in ml. If he or she uses incontinence aids, he or she can also specify the urine based on the incontinence aids by pressing button 494. Using button 496, the user can return to the home screen, of which examples will be described below. Also the buttons 492 and 494 will during the activity of the bladder protocol directly be accessible on the home screen.

Fig. 25 illustrates screen 500, which may be presented before the user can provide the amount of urine after pushing button 492 in screen 490. Screen 500 explains the scale ranging from 0 to 4 defining how the bladder felt before going to the toilet. The range is from 0, i.e., no sensation of needing to pass urine, up to 4, i.e., urgency and could not get to the toilet in time resulting in leaked urine. Pushing button 502 will lead the user to screen 510 which is illustrated in Fig. 26. In other examples, pressing button 492 may also directly lead to screen 510. In screen 510, the user can answer the described urgency scale using selector 512 and the amount of urine using selector 514. Also, the user can provide the time of urination, which may be prefilled with a current time, using the time input 516. The tracked urination can be saved using button 518.

Standardized Tests

Figs. 27 to 32 illustrate a user interface for a urine loss pad test, which is one example of a standardized test provided by standardized test component 220.

Screen 520 illustrated in Fig. 27 provides the user with information on the urine loss pad test, which helps the doctor to understand how much urine is lost during a particular exercise program. An informative content 522, for instance an explaining video, can be activated. The urine loss pad test is started after pressing button 524.

The first step of the urine loss pad test is illustrated in screen 530 illustrated in Fig. 28. The user is instructed to empty the bladder. After completion, he or she can press Done button 532, which will then lead to step 2 illustrated in Fig. 29.

Screen 540 in Fig. 29 illustrates the second step of the urine loss pad test. In this step, the user is instructed to drink 500 ml of water within 15 minutes, wherein acceptable are liquids such as water and fruit tea and unaccepted are liquids such as coffee or black tea. After completing step 2, the user can confirm completion of the step by pressing Done button 542, which will then proceed to the third step illustrated in screen 550 of Fig. 30.

Screen 550 requests the user to determine and note the empty weight of a dry pad. The user can select the weight determined with, for instance, a kitchen scale using input fields 552. In the example, the dry pad is determined to weight 50 g. After that, the user should insert the dry pad and proceed to the next step using button 554.

Step 4 of the urine loss pad test is illustrated in Fig. 31 , which shows screen 560 illustrating the standardized exercise program. It consists of 30 minutes of walking and stair climbing in loose alternation, getting out of bed from lying to standing 10 times, 10 times coughing, 1 minute fast running as fast as possible, bending the upper body 5 times, and 1 minute of washing hands with cold water. The user can click and activate each of the performed exercises using selector 562. As soon as all exercises are ticked or selected, the Done button 564 will be activated and selectable by the user. Selecting Done button 564 will proceed to the fifth step of the urine loss pad test, i.e., screen 570 as illustrated in Fig. 32.

In screen 570, the user may determine again the weight of the pad after the performed exercise program. The weight of the pad can be provided using input field 572. Pressing the See Result button 574 will lead the user to screen 580 illustrated in Fig. 33.

Based on a difference from the weight entered on screen 550 and the weight entered on screen 570, a net weight of urine loss in ml is obtained. In the example of screen 580, at the location indicated by arrow 582, the user is informed of a net weight of urine loss of 200 g. The user can finish the urine loss pad test using button 584. The results of the urine loss pad test are recorded, may be integrated into a doctor’s report or used for further processing.

Another example of the standardized tests is the bladder protocol, which may also be provided by standardized test component 220.

Questionnaires

Figs. 34 to 36 illustrate an example of a questionnaire generated by, for instance, questionnaire component 210. In this example, a screen 590 comprising a plurality of questions for a bowel movement test is illustrated. The bowel movement test in this example consists of eight questions 592, 594, 596, 598, 600, 602, 604 and 606, which may be answered by the user before finishing the questionnaire by pressing Finish button 608. The different questions may have different forms of providing a response. In the example of questions 592, 600, 602, 604 and 606, the user can select one out of a plurality of predefined answers. In other examples, also a plural selection of more than one of the provided answers is contemplated. Other responses include free text responses or, as in the example of questions 594, 596, or 598, the indication on a scale ranging, in this example, from 0 to 4.

In different cases, all questions have to be answered or it is acceptable if some of the questions remain unanswered. Further, in some examples, the course ofthe questions may be different depending on the answers to the previous questions. For example, in case the user answers not to take any medication, further questions regarding more specific details on the medication may be skipped.

The answers to the bowel movement tests are also recorded and made available for, for instance, a doctor’s report for the next doctor’s visit.

Figs. 37 to 39 illustrate another example of a questionnaire presented by the questionnaire component, namely a ICIQ-UI-SF urinary incontinence questionnaire presented as screen 610. The urinary incontinence questionnaire contains four questions 612, 614, 616, and 618. The first question 612 is how often the user leaks urine. The second question 614 asks how much urine the user usually leaks. The third question 616 asks how much leaking urine interferes with the user’s everyday life. Finally, question 618, which allows a multiple selection by the user, asks when the urine leaks. The answers to these questions can then be saved using Finish button 620.

In Figs. 37 to 39, the presentation of the urinary incontinence questionnaire is illustrated as part of the onboarding process, which is derivable from a progress bar on top of screen 610. Likewise, the urinary incontinence questionnaire can be generated in different other occasions. For instance, the urinary incontinence questionnaire can be presented to the user on a regular basis as a result of a periodic notification. Also, the questionnaire can be opened and filled by the user on his or her own initiative from a menu selection. Also, answers to previously filled urinary incontinence questionnaires can be modified and saved by the user. The same of course applies to all other questionnaires generated by questionnaire component 210. It is preferred that filled questionnaires may only be modified for a certain time, for instance, for one week after completion.

In one embodiment, the questionnaire component 210 can present the following questionnaires to the user and record and further process the user’s replies:

Q1 : Drug Use

Q2: Before Interim Doctor Visit (in 2-3 w) Q3: Before Follow Up Doctor Visit (after 3 mo)

Q4: Quality of Life (QoL) Question

Q5: After Interim Doctor Visit

Q6: Date of Follow Up Doctor Visit

SQ1 : ICIQ-UI-SF

SQ3: Bowel Movement Test (Stool Problems)

Some of these questionnaires appear couple of times during the user onboarding and for preparation to doctor visit, and some of them appear on a regular basis.

The user is able to see a list of questionnaires, which have been completed in the past. This list may contain all the questionnaires. The completed questionnaires can be reviewed and, if the questionnaire was previously submitted within the last X days, it may be edited. There is no way to change them later.

Main Menu

Preferentially, the application has a main menu 1500, which may appear on almost all screens of the application and which is now illustrated exemplarily with respect to Fig. 40. For instance, the main menu 1500 is displayed in a lower section of all screens, not limited to the example of Fig. 40. The menu 1500 comprises the following control elements or buttons:

Home 1510, which takes the user to the Home Page as described with reference to Figs. 86-95;

Exercises 1520, which takes the user to pelvic floor exercises described with reference to Figs. 65-74;

Urge 1530, which takes the user to the bladder training to start intervention exercise as will described with reference to Figs. 40 to 58;

Progress 1540, which takes the user to the progress page and view reports page as will be described with reference to Figs. 98-105; and

More 1550, which allows the user to open settings; to export doctor report, and the like as will be described with reference to Figs. 107-125.

The user can select any item in the menu, and the application will move the user to corresponding part of the application. Bladder Training

Fig. 40 schematically and exemplarily illustrates a bladder training screen 620, which may be generated by bladder training component 150. Bladder training screen 620 is presented as a result of the user’s pressing of an urge button, which is located as an easily accessible location, for instance at the bottom center, of other screens of the application.

After pressing the urge button, the user fills the urge assessment tracker before the bladder training screen 620 is shown.

The screen 620 allows the user to make a selection between different bladder training exercises, including a contracting exercise 622, a memorise exercise 624, a find exercise 626, an order exercise 628, a fly exercise 630, and a meditation exercise 632.

Fig. 41 illustrates a screen 640, in which the contracting exercise 622 is presented. The user is requested to contract the pelvic floor muscles for a certain amount of time, wherein for instance a timer may count this amount of time backwards. Preferably, the contracting time is 10 seconds, while also other durations are feasible.

Fig. 42 illustrates a screen 650, which is part of the memorise exercise 624. In screen 650, the user has the option to select the memorise size 652, the card back 654, the card images 656 and to start the exercise using start button 658.

Pressing button 658 will start the memorise exercise screen 660 as illustrated in Fig. 43. The exercise corresponds to the well-known card game in which all of the cards are laid face down on a surface and two cards are flipped face up over each turn. The object of the game is to turn over pairs of matching cards.

Fig. 44 illustrates a screen 670 presented after initiating order exercise 628. The plural tiles 672 have to be placed in numerical order, for instance by sliding the tiles 672 using the user’s finger.

Fig. 45 illustrates an initial screen 680 of the find exercise 626. A user can select a field size using option 682 and a task 684 to be completed by the user. The task can include to find all even or odd numbers, to find all numbers in numerical order, and the like. The exercise is started by pushing start button 686. Pushing start button 686 will lead to screen 690 illustrated exemplarily and schematically in Fig. 46 and Fig. 47. The task is indicated at position 696, in this case to find the tile with the number “2” printed thereon. The tile with the number “2” is located at position 692, wherein other tiles are distributed over the board, for instance tile 694. If the user accomplishes the task, i.e., finds and presses tile at position 692, he/she is asked with a prompt 698 whether he/she wants to continue or not.

Figs. 48 to 51 illustrate a screen 700 of the fly exercise or game 630. In this game, the goal is to save a mascot 702 from hitting a ground 704 of the screen. The mascot 702 can be moved left and right tapping left and right parts of the screen. Clouds 706 are to be avoided and useful objects 708 such as water, exercises, meditations and medication should be collected. Taking coffee increases the speed of the flying objects making the game harder. Objects fly faster when progressing within the game.

Fig. 52 illustrates a meditation screen 710, which is presented when pressing the meditate icon 630. The user has a selection between different meditative patterns 712, 714, 716, which are after selection presented full screen as illustrated in Figs. 53, 54, and 55. The user is supposed to concentrate on his/her breathing and the displayed figures or patterns. Contextual tips can be presented to increase concentration.

After finishing one of the bladder training exercises, a screen 720 as illustrated in Fig. 56 may be presented. Therein, the user my choose to have more bladder training using button 722 or to return to the home screen using button 724.

As part of the engagement concept, which is implemented using the engagement component 240, a screen 730 may alternatively or additionally be presented, in which the user is informed in a section 732 about his/her current progress with regard to the target achievement for today. The user my choose to have more bladder training using button 734 or to return to the home screen using button 736.

If the user’s target achievement is reached, a screen 740 as illustrated in Fig. 58 may be presented, in which a different notification is presented in section 742. Only a return to home button 744 is selectable so that bladder training can only be continued tomorrow.

When starting the bladder training for the first time, instructions screen 750 as shown in Fig. 59 may be presented to the user. Further, instructions screens 760, 770, 780, 790, and 800 as shown in Figs. 60-64 may be presented when activating the fly exercise 630, the meditation exercise 632, the order exercise 628, the find exercise 626, and the memorise exercise 624, respectively.

By activating a “Do not show this again” selector 752, the respective instruction screen will not be shown again the next time the bladder training I respective exercise is started again after confirming with continue button 754.

Pelvic Floor Exercises

The application provide the user with a course of pelvic floor trainings, which are provided by the pelvic floor exercises component 140. The pelvic floor training will now be described with reference to Figs. 65 to 74.

The user can start training at any time according to the description of the course provided in the next section. When the user enters the pelvic floor (PF) training area for the first time, for instance after receiving a notification or after pushing the corresponding button on the home screen, a mascot greeting screen 810 as shown in Fig. 65 may be presented.

After continuing via a Next button 812, a screen 820 including a welcome video 822 may be presented as appreciable from Fig. 66. Welcome video 822 explains the training concept. After these two steps the application moves the user to the Phase 1 .

At the first phase, which is also referred to as the base phase and which takes place from day 1 to day 7 after starting the training, the user needs to feel their pelvic floor muscles and learn how to contract them.

In the first phase, two videos as an example of a first content and a second content may be presented to the user one by one without delays. After, for instance, a further mascot message another video as an example of a third content may be presented.

After viewing the third content, an indication of completed training may be presented.

The user must complete 80% of required trainings to be moved to the next stage: 5 of 6 trainings must be completed.

Please note, the application preferentially does not count more than 2 trainings per day, i.e., the first part of Phase 1 takes at least 3 days. In the second part of the Phase 1 only the second content but not the first content is presented, since the user is already familiar with the first training.

After a mascot message, the third and a fourth content, e.g. videos, may be presented one by one without delays. After finishing the content, a message of the completion of the training may be presented.

Also in this phase, the user must complete 80% of required trainings to be moved to the next phase: 6 of S trainings must be completed. Please note, the application does not count more than 2 trainings per day.

At the second phase the user needs to strength pelvic floor muscles. In the second phase, i.e., Phase 2, different messages, e.g. mascot greetings or messages, and videos, e.g. content, are presented compared to Phase 1. In the beginning of Phase 2, a welcome screen 830 including an introduction video 832 as appreciable from Fig. 67 may be presented.

Likewise, in Phase 3, different messages, e.g. mascot greetings or messages, and videos, e.g. content, are presented compared to Phase 1 and 2.

The user must complete 50% of required trainings to be moved to the next phase: 21 of 42 trainings must be completed. Please note, the application does not count more than 2 trainings per day.

Fig. 68 illustrates a screen 840 which may be presented as a morning message to the user to remind him/her of the pelvic floor exercises. Using a button 842, the exercise session may be started.

Fig. 69 illustrates an introductory screen 850, which explains an individual exercise, in this case, a laying exercise. For example, an introduction video 852 as an example of a specific content is shown.

At the Phase 4, of which a welcome screen 860 is schematically and exemplarily illustrated in Fig. 70, the user is required to have 2 (two) extended trainings per week. This is explained using introduction video 862. Extended training means that the user needs to complete training 2 times in a row, which is notified to the user using screen 870 in Fig. 71 . The notification screen 870 allows to start training for another 7 minutes, i.e., to carry out the extended training, using Yes button 872 or to postpone the extended training to a later stage using No button 874.

When the user has selected, for instance, an “I’m ready” command, the application moves the user to the next screen with a video and starts playing the video preferentially automatically.

When the video is ended, the application moves the user to the next screen automatically.

The user should be able to skip introduction part of the video with exercises. To do it each video with exercises has “Skip intro” button, which moves the user to the part with exercises.

When the user starts selected pelvic floor exercises the application moves the user to the step which depends on how many days or trainings the user has completed (e.g. user has completed 2 trainings per day during 12 days, then the application shows Phase 2).

When the user has started pelvic floor exercises, the application shows instructions how to do each exercise and provides the user with video instructions.

When the user completed the exercises the application automatically update the pelvic floor exercises tracker. The application stores the number of completed trainings, i.e. there is a chance that the user has more than required 2 trainings per day.

Figs. 72 to 74 illustrate screens 880, 890 and 900 which are examples of exercise selector screens. The different pelvic floor exercises may be grouped into breathing exercises, power exercises, endurance exercises or freestyle exercises. A video may be presented depending on the selected exercise and phase of pelvic floor training. Further, the choice of exercises may depend on the phase of the pelvic floor training.

Engagement/Gamification

Part of the engagement concept is a reward obtainable by the user when complying with the daily data collection and exercises. This reward concept may be implemented by a reward subcomponent of the engagement component 240. The main goal of this feature is to engage the user, motivate them to follow recommendations and provide information regarding their health. In this example, the reward concept is implemented by awarding stars to the user. On the first day, one star is awarded. The more successive days in a row the daily data collection and exercises is complied with, the more stars are awarded, for instance four stars for the fourth day in a row. Additional bonus stars may be awarded when completing one week of complying with the daily data collection and exercises.

The application shows, for instance, a mascot on the landing page after the user opened the application. The mascot reacts on the recent changes in the trackers, recommendations, scheduled standardized tests and questionnaires. The mascot can express different emotions in response to the recent changes.

The next actions of the user needs to be considered as a point when mascot’s emotion can change: Enter tracking data; Fill Tracker; Fill Medication Tracker; Complete Questionnaire, Take Standardized Test.

The application shows a textual description which indicates the patient’s position among other patients of the same age group (please see age groups in Patient Groups) and at the same stage of treatment (the same week of application usage). This is referred to as the segmentation and positioning subcomponent of the engagement component 240.

The application calculates a segmentation for all age groups for each week of the course (not for each day), and then compare average adherence score of the specific user with the appropriate segmentation (same age group and same week of application usage). The overall adherence score will be further described below in detail.

For instance, the user average adherence score may, without limitation, be clustered in five groups, Group A ranging from 0-30% adherence, Group B ranging from 30-50% adherence, Group C ranging from 50-70% adherence, Group D ranging from 70-90% adherence, and Group E with more than 90% adherence.

The user can earn coins or stars for providing the data to the following trackers: Drink tracker; Micturition tracker; Medication tracker (if it’s on).

The rules for earning coins or stars are described below and will be described with reference to Figs. 75-78. Of course, also other rules for being rewarded may be implemented. When required data is tracked for the first day, 1 coin or star is awarded as appreciable from screen 910. With each consecutive day up to one week, the amount of coins or stars is increased. For instance, as appreciable from screen 920, after four days the awarded stars may be four for the fourth day.

When the required data is not tracked, then the next day a screen 930 may be presented and the user can earn 1 coin only (please see #1) and so on.

When all required trackers have been filled for 7 days in a row, then the user gets a strike - 3 coins as appreciable from screen 940.

If the tracking data has been provided retroactively then the application does not count such data for getting additional coin(s).

Notifications

The application has several types of notifications: In-app notifications at the landing page, In-app Notification After User Action; Reminder notifications and Email notification.

When the user has received in-app notification or several of them on the landing page and then opened the Home page, the Home page reflects these in-app notifications, i.e. indicates trackers or menu items which are related to these in-app notifications. So the user is able to quickly understand what data they need to provide and what actions they need to do.

When the user has provided tracking data to a tracker with an indication, the indication disappears from the home page: Indications for liquid trackers (Liquid consumption and Caffeine containing dinks consumption). When the user has provided data to liquid consumption tracker, the indication for both liquid trackers disappears.

When the user has provided data to caffeine containing drinks tracker, the indication for the caffeine containing drinks tracker may disappear.

Indication for micturition tracker may disappear after the user provided data to the tracker.

Indication for pelvic floor exercises may disappear after the user completed pelvic floor exercises. Indication for micturition protocol may disappear after the user provided urine volume to the protocol.

Indication for medication tracker may disappear after the user tracked (an) appropriate medication(s) (which should be taken according to the medication tracker).

If the user did not tracked the medication and it is time to take the next dose, then the previous indication (A) may be overridden by the new one (B). Note: indication (A) will not appear again, even after indication (B) disappeared.

Scheduled standardized tests and questionnaires section may disappear when the user completed/started standardized test or questionnaire.

There are two types of indication: 1) indication of required activities/actions which may be indicated with green dots. This type of indication may appears when the user receives the following morning or evening routine in-app notifications.

If the user did not do required actions during the X hours, this type of indication changes to an indication of missed activities/actions, which may be indicated with red dots. This type of indication shows up when the user received two or more notifications which require activities/actions or for notifications listed for indication type 1) after X hours.

For example, Fig. 79 illustrates a notification screen 950 which reminds the user to take his/her pills. A medication tracker 952 in which the prescribed medication can be directly tracked is presented together with an urge button 954, which will lead to the urge tracker and bladder training described above.

Fig. 80 illustrates a notification screen 960, in which the user is reminded of o scheduled doctor’s visit. He/she can take the required urine loss pad test activating button 962 and access the required bladder protocol using button 964. Also on this screen an urge button 966 is provided to have direct access to the urge tracker and bladder training.

Fig. 81 illustrates a further notification screen 970, in which the user is reminded about the relevance of regularly going to the toilet. He/she can on this screen directly track liquid intake 972, coffee intake 974, and a micturition 976. Further, an urge button 978 is presented. Figs. 82 to 85 illustrate further notification screens 980, 990, 1000, and 1000, which may be presented to the user under different preconditions.

For instance, screen 980 in Fig. 82 motivates the user and allows to directly track liquid intake 982, coffee intake 984, and micturition 986. Also an urge button 988 is included.

In Fig. 83, screen 990 motivates the user after 2 days of absence from the app. It includes more than one action to perform, such that a link 992 to the home page to perform the respective actions is provided. Further, an urge button 994 is provided.

In Fig. 84, screen 1000 motivates the user to establish a regular toilet rhythm. The user can on this screen directly track liquid intake 1002, coffee intake 1004, and a micturition 1006. Further, an urge button 1008 is presented.

In Fig. 85, screen 1010 reminds the user to fill out the micturition protocol. A link 1012 to the bladder protocol is therefore provided. Further, an urge button 1014 is presented.

Home Page

When the user just logged in to the application the home page appears on the screen. The content presented on the home page depends on various parameters. A plurality of different and non-limiting examples of screens 1060, 1070, 1080, 1090, 1100, 1 110, 1120, 1130, 1140, and 1150 including the content of the home page is illustrated in Figs. 86 to 95.

The home page may comprise one, more or all of the following: a section 1020 presenting scheduled standardized tests and questionnaires for today; a section 1030 presenting a list of trackers, in particular a liquid tracker 1032, a coffee tracker 1034, a micturition tracker 1036; a medication tracker 1038 and a link 1040 to trackers history; and a section 1050 providing knowledge about the disease. The last item appears on the home page after the user completed the onboarding process and allows that the user can watch video clips. In a preferred embodiment this item on the home page disappears when either the user watched all video clips in the section or after 1 week of using INKA.

When the user has collected sufficient coins or rewards, the application shows the user a view coins section 1052 on the homepage, which will bring the user to a donation screen 1160 described later with reference to Fig. 96. The section 1020 presenting standardized tests and questionnaires allows the user to see scheduled for today standardized tests and questionnaires if any. The user is able to start a standardized test/questionnaire and then leave it uncompleted for a while, then they can get back to it again.

It contains the following:

1 . Scheduled for today: Scheduled for today questionnaires are visible in this section for the next X days; Standardized tests are available until the user completed them.

2. Started, but not completed yet: Questionnaires; The user is able to complete started, but not completed questionnaires during the next X days; Some standardized tests assumes that the user needs to provide information during several days (e.g. Bladder Protocol requires 3 days), that is why these kind of tests must be present in the section for those days.

Each questionnaire and standardized test can optionally have one or more of the following: Name of the questionnaire or standardized test; a progress bar which indicates how many questions have been answered/not answered in the questionnaire/standardized test; and quick access to data entry, which makes data entry easy, for example for the bladder protocol.

In screen 1110, the application realizes that the user recently had a doctor’s visit and asks the user in a section 1102 about changes to the medication prescription. The medication tracker can easily be updated accordingly.

Other personalized and individual questions can additionally or alternatively be included on the homepage, for instance a question 1152 of how the quality of life is rated by the user in regard to the bladder problem last week.

Donation

A screen 1160 illustrated in Fig. 96 with information on how to spend their coins or reward stars is accessible by selecting view coins section 1052.

The user must have a certain amount of coins/stars or more to donate them. This is a part of user motivation to provide data to the trackers. After the user selected a donate option 1062, a confirm prompt 1170 as illustrated in Fig. 97 is presented, in which the user can confirm or cancel the donation.

Progress page

The progress page screen 1180 is generated by progress report component 170 and schematically and exemplarily illustrated in Figs. 98 to 100. It includes the following:

A segmentation and position section 1182, which may be generated by a segmentation and positioning subcomponent as part of the engagement concept. The progress page shows textual description of patient’s position against other patients in the same age group.

A list 1184 of different adherence scores, which are generated based on historical tracking data provided by the user. The adherence scores are evaluated by adherence evaluation component 160.

View Adherence Scores

The application generates and is configured to present both individual adherence scores of a liquid volume adherence 1185, a coffee adherence 1186, a medication adherence 1187, a pelvic floor exercises adherence 1188, and a bladder training adherence 1189 as well as a combined adherence on top of the list. The combined adherence score allows for the user to directly and easily recognize his/her progress.

In the examples of Fig. 98 to Fig. 100 the individual adherence score values and the overall adherence result are illustrated encoded as circular segments, a higher adherence corresponding to a larger circular segment. The overall adherence result is encoded as concentric circular segments of the individual adherence score values. In other examples, other forms of displaying or presenting the adherence scores are contemplated.

Expressed differently, in these examples the visualization element, which indicates the current score, is presented as a segment of a circle. It indicates the current score relative to maximum and minimum scores. Instead of a circular segment, a progress bar or the like could be used.

Some of the scores may have target value, which the user set. The adherence scores list 1184 includes preferentially textual description which indicates what can be improved. In one example, the liquid volume adherence 1185 is determined as follows. The user follows drink behaviour recommendations, which consist of the following: drink more than 1 .5 I of liquid per day, and drink not more than 1 .6 I of liquid per day. (Target is between 1 .4 I and 1 .6 I). The textual recommendation may be to reduce the volume of liquid up to 25%, but keep the volume above 1 .5 I.

The liquid consumption adherence score is preferentially calculated as the average of the Day scores for the previous 7 days, where Day score is a sum of a Static Score (Max=50) and a Moving Score (Max=50), where Static score = Normal distribution (mean = 1.5, standard deviation = 0.2) with 100% threshold between 1 .4 and 1 .6 liters (Max of the static score is 50, i.e. 100% of static score is 50% of the Day score.

Moving score: If 1 .4 I <= yesterday liquid consumption <= 1 .6 I then Moving score = 50. If yesterday liquid consumption = day before yesterday liquid consumption then Moving score = 0; If yesterday liquid consumption > day before yesterday liquid consumption then Moving score = 0; If yesterday liquid consumption < day before yesterday liquid consumption then; Moving score = 50 when difference is 25% and goes down to 0 when difference is 0%.

In one example, the coffee adherence 1186 is determined in accordance with whether the user follows caffeine consumption recommendations as follows. Drinking 1-2 cups of coffee is ok, for 3 or more cups of coffee it is recommended to reduce the coffee consumption.

The following formula to be used for calculation the liquid consumption adherence score: Score = Average of Day scores for previous 7 days, where Day score = 100, when tracked 0 - 2 cups of coffee, 50, when tracked 3 cups of coffee, and 0, when tracked 4 or more cups of coffee.

In one example, the medication adherence 1187 is calculated using the next formula: Score = Average of Day scores for the previous 7 days, where Day score = Number of medications taken (Medication tracker data) * Max I Number of doses of medication to be taken per day.

This score is visible to those patients who have set up the medication tracker.

The textual information may be distinguished between the following cases: The user has not missed a single dose of medications; The user has missed one dose of any medication; The user has missed two or more doses of medications; and the user has missed all doses of medications.

The pelvic floor exercises adherence 1188 score is calculated using the next formula: Score = Average of Day scores for the previous 7 days, where Day score = Number of pelvic floor exercises done (Pelvic floor exercises tracker data) * Max I The number of required Pelvic floor exercises a day (2 pelvic floor exercises a day).

If the user did not provide data to the tracker for a day, then the application should count it as 0 (zero).

The textual information may be distinguished between the following cases: When the user has not missed a single pelvic floor exercises in the last 7 days (i.e. Score = 100); When the user has missed one or more pelvic floor exercises in the last 7 days (i.e. 0 < Score < 100); and when the user has missed all pelvic floor exercises in the last 7 days (i.e. Score = 0).

The bladder training adherence 1189 score or target is set according to the tracking data in the micturition tracker (i.e. intervention exercises target). The following targets may in one example be implemented:

Users who have average micturition (AM) during the week as: 5<=AM<15. Bladder training target: 2 bladder trainings per day, >=15 minutes each training.

Users who have average micturition (AM) during the week as: 15<=AM<25. Bladder training target: 3 bladder trainings per day, >=5 minutes each training.

Users who have average micturition (AM) during the week as: 25<=AM. Bladder training target: 4 bladder trainings per day, >=5 minutes each training.

The calculation of adherence score works like following: Score = Average of Day scores for the previous 7 days, where Day score = Number of executed trainings with required duration * 100 / Required number of trainings.

Reporting The reporting functionality represents data entered by the user into trackers, standardized tests, and questionnaires on charts. These charts provides users with ability to see how their health status related to their urinary incontinence problem/OAB changes over time. Also, with the help of these diagrams, the user can monitor their progress in treatment.

Fig. 101 to Fig. 106 schematically and exemplarily illustrate various reporting screens 1190, 1200, 1210, 1220, 1230, and 1240, which are generated by progress report component 170.

The application represents data entered by the user in trackers and standardized tests in a form of charts.

Different data to be represented on a single diagram:

Liquid consumption;

Caffeine containing drinks consumption;

Micturition.

The user is able to change dates of displayed period:

They can change dates back until they reached the earliest period with tracking data;

They can change dates forward until they reached the period with yesterday’s date.

The user can select an element of the chart (e.g. a bar on a bar chart) to see more details on the tracking data.

In Fig. 101 , screen 1190 presents the history of liquid volume in liters over the last two weeks. It can be seen that the average fluid intake was 2.3 liters per day, with two days below the recommended volume of 1 .5 liters.

In Fig. 102, screen 1200 presents the number of micturition over the last week. It can be seen that the user’s value has increased from 29 to 31 times.

In Fig. 103, screen 1210 presents a case in which the number of daily toilet visits has decreased from 29 to 26 over the last week. Fig. 104 and Fig. 105 show further screens 1220 and 1230 illustrating the report on liquid volume intake. The report shown in screen 1220 displays the report over a specified time period, in this example from October 18 to October 24. In screen 1230, the history for the last week is shown.

Fig. 106 illustrates in screen 1240 the history of coffee consumption over the last week.

Data Export

Application’s data export feature provides users with ability to export data gathered in the application in a form of printable reports. The printable reports are preferably generated by download report component 180. A link to the report may be sent via e-mail or the report may, for instance in pdf format, directly downloadable within the app.

For instance, as illustrated in Fig. 107, the user is able to export a bladder protocol which contains data captured by the application, which may be generated using a generate report button 1242 on screen 1240. The screen 1240 may be accessible from various locations, for instance the more button included in the main menu or a settings menu.

Correspondingly, as illustrated in screen 1250 of Fig. 108, a doctor’s report providing relevant information in preparation to a doctor’s visit can be generated using generate doctor report button 1252. Two examples of a doctor report are illustrated in Fig. 1 11 and 112.

Likewise, user data can be exported on a screen 1260 using a button 1262 as illustrated in Fig. 109.

When the data export is performed by sending an e-mail to the user, an export confirmation screen 1270 with a link 1272 back to home may be presented as illustrated in Fig. 1 10.

The user is able to export a doctor report which contains data captured by the application. Preferably, the doctor report includes information after the user has completed before doctor visit questionnaire (the user should be able to export the doctor report even if they did not complete some of the questionnaires/standardized tests assumed by the before doctor visit questionnaire): Before Follow Up Doctor Visit (after 3 mo); Before Interim Doctor Visit (in 2-3 w). The user may select a doctor visit preparation function. The function is activated when the user registers that he/she has a scheduled next doctor visit by pressing yes button 1282 on screen 1280 of Fig. 1 11 , or, if the next doctor visit is already registered within the app, by pressing next button 1292 on screen 1290 as illustrated in Fig. 112.

When the user has selected this item the application shows confirmation dialog with three options: Start preparation for the interim doctor visit: Before the doctor visit, the bladder protocol, medication history, urine loss pad test, urinary incontinence questionnaire and bowel movement test should be completed as illustrated in screen 1300 on Fig. 113.

If the required information is provided, an export button 1302 becomes selectable on the screen 1300 as illustrated in Fig. 1 14.

After pressing the export button 1302, the user is prompted to confirm the export on a screen 1310 as illustrated in Fig. 115. If the user presses cancel button 1314, the action is cancelled. Upon confirming by pressing export button 1312, the doctor report is directly provided and/or a clickable link sent via e-mail as described above.

Fig. 116 schematically and exemplarily illustrates a doctor report 1320 which may be generated before an interim doctor visit, i.e., after 2-3 weeks of using the system 1 .

Fig. 117 schematically and exemplarily illustrates a further doctor report 1330 which may be generated before a follow up doctor visit, i.e., e.g. after 3 months of using the system 1 . It can be seen that in particular the progress of the term of use may be directly appreciated from doctor report 1330.

History

Fig. 118 illustrates a trackers history screen 1340. Trackers history screen 1340 includes a calendar element, in which the user can select the day for which the history of the trackers is to be reviewed. The individual trackers (liquid tracker, coffee tracker, micturition tracker and medication tracker) are illustrated below the calendar element. The data of the respective trackers may be reviewed and/or edited by the user.

Fig. 119 illustrates a questionnaire history screen 1350. the questionnaire history screen 1350 enables the user to review and/or edit past urine incontinence questionnaires, urine loss pad tests, bladder protocol, quality of life check, and the like. Fig. 120 illustrates schematically and exemplarily a bladder protocol history screen 1360, which may be accessed by selecting a bladder protocol history in the questionnaire history screen 1350. The bladder protocol history screen 1360 provides a summary to the past completed bladder protocol. By pressing review data button 1362, the individual data entries to the bladder protocol can be reviewed and/or edited on a bladder protocol detail screen 1370 as illustrated in Fig. 121.

The bladder protocol detail screen 1370 allows to select editing number of pads button 1372, which will provide an edit number of pads screen 1380 as illustrated in Fig. 122. The user can select and save the number of pads on this screen.

Further, the bladder protocol detail screen 1370 allows to edit the individual toilet visits and/or add a further toilet visit to the bladder protocol by pressing one of the corresponding buttons 1374. The user will be shown a screen 1380 in which the level of urge together with urine volume and time can be defined and saved, as illustrated in Fig. 123.

Fig. 124 illustrates a quality of life screen 1400, in which the user can edit his/her response to the quality of life questionnaire.

Fig. 125 illustrates a urine loss pad test screen 1410, in which the user can edit his/her response to the urine loss pad test.

In settings screen 1420 illustrated in Fig. 126, the user can adjust the settings of the application. By pressing view profile link 1422, the profile screen 1430 illustrated in Fig. 127 is presented, which allows the user to view and edit settings of the profile including contact details and/or personal information.

Pressing notification settings link 1424 takes the user to a screen 1440 illustrated in Fig. 128, in which the status and corresponding time of notifications can be adjusted.

Further, pressing medication tracker settings link 1426, the user is taken to a medication tracker settings screen 1450 illustrated in Fig. 129, in which the medication tracker can be activated or deactivated and the tracked medication can be reviewed and modified

Engagement concept The engagement concept of the present invention is summarized and visualized in Fig. 130. It consists of thee main pillars “Education Therapy Guidance”, “Exercise Behaviour” and “Self-Monitoring”, wherein the described technical and medical effect is a result of the overlap of all pillars. The combination of Education and Therapy Guidance with the Exercise Behaviour helps for the user to accept the and understand the therapy. In combination with the self-monitoring, the user adherence to the therapy is assisted and reporting is enabled.

Assisting building blocks for the engagement concept include event-based notifications, reminders, awards & donations, and the peer comparison with other users.

Medication tracker

In one example, medication selectable in the medication tracker may be any medication comprising at least one of the active substances contained in the following list: trospium chloride, solifenacin, propiverine, mirabegron, oxybutynin, duloxetine, fesoterodine, desfesoterodine, tolterodine, darifenacin, desmopressin, imipramine, cucurbita pepo L., botulinum toxin, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin, ephedrine, phenylpropanolamine, midodrine, ascorbic acid, flavoxate, causticum hahnemanni, plantago major, vaccinium macrocarpon, populus tremuloides.

Systematic Evaluation

As part of the clinical evaluation a study is conducted.

The study is conducted as a a multicentric, prospective, controlled, randomised studyin 180 patientsindication: GAB with or without urinary incontinence (Ul) or in combination with stress urinary incontinence (mixed incontinence) covering the International Statistical Classification of Diseases and Related Health Problems (ICD-Codes): 10: N32.8; N39.42; N39.42 + N39.3; N39.3 + N39.42; N39.3 + N32.8; N39.46. The study duration is 12 weeks.

The evaluated intervention was the treatment INKA app (MDR class I app - CE-marked).

The INKA system 1 is intended to

• monitor therapy progress

• alleviate symptoms - M - detect and modify behaviour enhance quality of life.

INKA has a program for motivating patients as well as various functions for personalized therapy support and monitoring:

• Pelvic floor training

• Learning content on disease, causes, behaviour

• Drinking recommendations

• Bladder training

The duration of intervention is 12 weeks

Study objectives:

Primary objectives: To investigate the medical effect of the digital therapy companion INKA system 1 concerning the change of symptoms associated with OAB or mixed incontinence regarding the number of micturitions per day (bladder protocol)

Secondary objectives: To determine the effect of INKA with regards to the change of symptoms and behavioural changes leading to possible health improvement:

Changes in

• the amount of unwanted urine loss (urine loss PAD (1 hour) test)

• patients’ quality of life measured by questionnaire (ICIQ-OABqol)

• disease specific symptoms measured by questionnaires (ICIQ-OAB, ICIQ-UI-SF)

• disease specific symptoms measured by bladder protocol

• disease specific symptoms measured continuously via App

• number of pads by bladder protocol

• adherence regarding intake of prescribed medication and regarding drinking volume, caffeine consumption, execution of bladder training, execution of pelvic floor training

The Study population was grouped as follows:

- Intervention-group 1 : 60 patients suffering from overactive bladder syndrome with III (allocation based on the answer to the following question of ICIQ-UI-SF at visit 1 (enrolment) “How often do you leak urine?" Answer: “about once a week or less often” or “two or three times a week” or “about once a day” or “several times a day” or “all the time”) - Control-group 1 : 60 patients (indication as specified in group 1)

- Intervention-group 2: 30 patients suffering OAB without Ul (allocation based on the answer to the following question of ICIQ-UI-SF at visit 1 (enrolment) “How often do you leak urine?" Answer: ’’never”)

- Control-group 2: 30 patients (indication as specified in group 2)

Inclusion criteria:

• Confirmed OAB with or without Ul or in combination with stress urinary incontinence (mixed incontinence) established by a urologist

• Sex: male/female

• Age: 18 years or older

• Patients receiving stable pharmacological treatment for included indications for at least >4 weeks before visit 1

• Ability to read and write German

• Access to a smartphone and capability to use it

• Informed consent (agrees that her/his data will be transferred and evaluated)

Exclusion criteria

Ongoing pregnancy

Severe heart insufficiency

Severe kidney insufficiency

Former surgery which may interfere with pelvic floor exercises if wound healing is not completed

Known malignancy in lower abdomen

Unassessed difficulties in emptying bladder

Visual blood in urine

Three or more urinary tract infections during the last 12 months

Severe psychiatric disorder possibly resulting in non-compliance

Regular pelvic floor muscle training during the last month (with or without support by an app)

Neurological disease affecting the urinary tract (for details see study protocol)

Pure stress incontinence without OAB

Current Botox treatment of the urinary bladder For primary and secondary outcome measures descriptive statistics will be provided. Further exploratory analyses will be performed. The whole study population as well as the intervention-groups (1 , 2) and control-groups (1 , 2) will be analysed. Furthermore, possible correlations between different parameters will be analysed.

Primary outcome measure for intervention-groups and control-groups: Percentage change of micturitions per day (average from 3-day bladder protocol*) from baseline (visit 1) to 12 weeks (visit 2). The 3-day bladder protocol measures are: number of micturitions (n), urine volume (ml), number of pads (n), intensity of urgency (score 0-4)

Secondary outcome measures for intervention-group 1 , 2:

• Change in the mean amount of urine loss in g (measured by PAD (1 hour) test according to Krhut et al. 2014) from baseline (visit 1) to 4 weeks, to 12 weeks (visit 2)

• Change in the overall score of the quality-of-life questionnaire ICIQ-OABqol* from baseline to 4 weeks, to 12 weeks; The ICIQ-OABqol is a patient-completed questionnaire for evaluating quality of life in patients suffering from OAB symptoms, including 26 items with an overall score of 25-160 overall score with greater values indicating increased impact on quality of life.

• Change in the total score of the questionnaire ICIQ-OAB from baseline to 4 weeks, to 12 weeks; The ICIQ-OAB is a patient-completed questionnaire for evaluating overactive bladder syndrome, including 4 items with an overall score of 0-16 with greater values indicating increased symptom severity.

• Change in the total score of the questionnaire ICIQ-UI-SF from baseline to 4 weeks, to 12 weeks; The ICIQ-UI-SF is a patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life of urinary incontinence, including 4 items with an overall score of 0-21 with greater values indicating increased symptom severity.

• Change in the mean number of PADs (n) used per day from baseline to 4 weeks, to 12 weeks (3-day bladder protocol)

• Change in the mean intensity of urge (score 0-4) from baseline to 4 weeks, to 12 weeks (3-day bladder protocol) • Change in the frequency of the use of the urge button (n) per day during whole study period (continuous recording)

• Change in the mean intensity of urge via urge button (score 0-4) during whole study period (continuous recording)

• Change in the mean number of micturitions (n) per day during whole study (continuous recording)

• Changes in the mean number of micturitions (n) during the day (6 a.m. - 10 p.m., 3-day bladder protocol)

• Changes in the mean number of micturitions (n) during the day (6 a.m. - 10 p.m.) during whole study (continuous recording)

• Changes in the mean number of micturitions (n) during night (10 p.m. -6 a.m., 3-day bladder protocol)

• Changes in the mean number of micturitions (n) during night (10 p.m. -6 a.m.) during whole study (continuous recording)

• Changes in the mean number of urine leakage (n) per day (3-day bladder protocol)

• Changes in the mean urine volume (ml) per micturition (3-day bladder protocol)

• Changes in the mean drinking volume (ml) per day (continuous recording)

• Changes in the mean caffeine consumption (cups, recommended max.200 mg/day) per day (continuous reporting)

• Changes in the mean number of executed bladder trainings per day (adherence, continuous reporting)

Execution of pelvic floor exercises as recommended (adherence, continuous reporting)

Changes in the frequency and continuity of using INKA (continuous reporting) • Completeness of documented intake of prescribed medication (adherence, continuous reporting)

Secondary outcome measures for control-group 1 , 2:

• Change in the mean amount of urine loss in g (measured by PAD (1 hour) test*) from baseline (visit 1) to 4 weeks, to 12 weeks (visit 2)

• Change in the overall score of the quality-of-life questionnaire ICIQ-OABqol from baseline to 4 weeks, to 12 weeks

• Change in the total score of the questionnaire ICIQ-OAB from baseline to 4 weeks, to 12 weeks

• Change in the total score of the questionnaire ICIQ-UI-SF from baseline to 4 weeks, to 12 weeks

• Change in the mean intensity of urge (score 0-4) from baseline to 4 weeks, to 12 weeks (3-day bladder protocol)

Visit and self-assessment schedule for patients of the intervention-group: Visit 1 at the urologist, patients of the intervention-groups receive activation code (enrolment). Patient activates code and watches introductory videos (“onboarding”). Patient performs within 7 days after activation: • Bladder protocol over 3 consecutive days

• Pad (1 hour) test

• ICIQ-OABqol

• ICIQ-OAB

• ICIQ-UI-SF

Day 1 activation of INKA App once all mandatory activities (onboarding process, Pad test, start bladder protocol, start with education program) have been performed. Start of INKA training program. Repetition of all required activities in week 4 and week 12 according to schedule. Visit 2 at the urologist week 12 +/- 3 days

Visit and self-assessment schedule for patients of the control-group: Patients will receive care-as-usual treatment including 2 visits at the urologist. Visit 1 at the urologist: patients of the control-groups receive an access code for the web-based application (enrolment). Patients of the control group will perform within 7 days:

• Bladder protocol over 3 consecutive days

• Pad (1 hour) test

• ICIQ-OABqol

• ICIQ-OAB

• ICIQ-UI-SF

Repetition of the mentioned activities in week 4 and week 12 according to schedule. Visit 2 at the urologist week 12 +/- 3 days

The flow chart by procedure is schematically and exemplarily illustrated in Fig. 131.

Finally, Fig. 132 schematically and exemplarily illustrates the phases of the pelvic floor training. The phases include, in order, a base phase 1600, a strength phase 1610, an endurance phase 1620, and a strength and endurance phase 1630. The base phase 1600 may be separated into a first part taking place from day 1 to day 3 and a second part taking place from day 4 to day 7, the strength phase 1610 takes place from day 8 to 28, the endurance phase 1620 takes place from day 29 to 49, and the strength and endurance phase 1630 takes place from day 50 to 84. Two daily training sessions are required in the strength and endurance phase 1630. The length of the phases is a minimum duration and is adjusted appropriately dependent on the user’s completion of required trainings.

Claims

1 . A system for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, in particular at least one of reduction of micturitions and reduction of urine loss, comprising a liquid volume tracking component for tracking a liquid intake of the user, a coffee tracking component for tracking a coffee intake of the user, a medication tracking component for tracking a medication adherence of the user, a pelvic floor exercises component for providing pelvic floor exercises to the user and tracking an intended execution, a bladder training component for providing bladder training exercises to the user and tracking an intended execution, and an adherence evaluation component for self-monitoring, the adherence evaluation component being configured to obtain an adherence score value from each of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, and the bladder training component, and to obtain an overall adherence result of the user based on the obtained adherence score values.

2. A system for assisting alleviating overactive bladder syndrome and incontinence symptoms of a user, the alleviation being expressed as a reduction in tracked daily micturitions over the course of using the system, the system comprising a liquid volume tracking component for tracking a liquid intake of the user, a coffee tracking component for tracking a coffee intake of the user, a medication tracking component for tracking a medication adherence of the user, a pelvic floor exercises component for providing pelvic floor exercises to the user and tracking an intended execution, a bladder training component for providing bladder training exercises to the user and tracking an intended execution, and an adherence evaluation component, wherein the combination of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, the bladder training component and the adherence evaluation component is effective to reduce the number of micturitions of the user using the system.

3. The system according to either of claims 1 and 2, wherein the alleviation of overactive bladder syndrome symptoms of the user using the system can be determined by at least one of:

• a change in the mean amount of urine loss in grams as measured by a 1 hour PAD test from baseline, i.e. visit 1 , to 4 weeks to 12 weeks, i.e. visit 2;

• a change in the overall score of the quality-of-life questionnaire ICIQ-OABqol* from baseline to 4 weeks, to 12 weeks;

• a change in the total score of the questionnaire ICIQ-OAB from baseline to 4 weeks, to 12 weeks;

• a change in the total score of the questionnaire ICIQ-UI-SF from baseline to 4 weeks, to 12 weeks;

• a change in the mean number of PADs used per day from baseline to 4 weeks, to 12 weeks using a 3-day bladder protocol;

• a change in the mean intensity of urge expressed as a score ranging preferably from 0 to 4 from baseline to 4 weeks, to 12 weeks using a 3-day bladder protocol;

• a change in the frequency of the use of an urge button per day during whole study period;

• a change in the mean intensity of urge via urge button expressed as a score ranging preferably from 0 to 4 during whole study period;

• a change in the mean number of micturitions per day during whole study;

• changes in the mean number of micturitions during the day, preferably between 6 a.m. - 10 p.m., using a 3-day bladder protocol;

• changes in the mean number of micturitions during the day preferably between 6 a.m. - 10 p.m., during whole study;

• changes in the mean number of micturitions during night, preferably between 10 p.m. -6 a.m., using a 3-day bladder protocol)

• changes in the mean number of micturitions during night, preferably between 10 p.m. -6 a.m., during whole study; • changes in the mean number of urine leakage per day using a 3-day bladder protocol;

• changes in the mean urine volume (ml) per micturition using a 3-day bladder protocol;

• changes in the mean drinking volume (ml) per day;

• changes in the mean caffeine consumption per day;

• changes in the mean number of executed bladder trainings per day;

• execution of pelvic floor exercises as recommended;

• changes in the frequency and continuity of using the system; and

• completeness of documented intake of prescribed medication.

4. The system according to any of the preceding claims, further comprising a progress report component, the progress report component comprising an adherence report subcomponent being configured to generate a single interface for reporting the individual adherence score values and the obtained overall adherence result to the user.

5. The system according to claim 4, wherein the adherence report subcomponent is configured to encode at least one of the individual adherence score values and the overall adherence result as circular segments, a higher adherence corresponding to a larger circular segment.

6. The system according to claim 5, wherein the adherence report subcomponent is configured to encode the overall adherence result as concentric circular segments of the individual adherence score values.

7. The system according to any of the preceding claims, wherein one, several or all of the liquid volume tracking component, the coffee tracking component, the medication tracking component, the pelvic floor exercises component, the bladder training component, and the adherence evaluation component are implemented as functional modules of a smartphone app.

8. The system according to any of the preceding claims, further comprising a download report component, the download report component being configured to generate at least one of a doctor report, a user data export report, and a bladder protocol for the user.

9. The system according to claim 8, wherein the download report component is configured to provide the user with an email notification including a link for downloading the report, the link having an expiration period.

10. The system according to any of the preceding claims, further comprising an onboarding component, the onboarding component being configured to register a user and collect data from the user for the operation of further components of the system, including collecting data on prescribed medications for overactive bladder syndrome treatment for the medication tracking component, special dietary requirements regarding drinking volume and coffee consumption for the liquid volume tracking component and the coffee tracking component, and assessment data based on the ICIQ-UI-SF questionnaire.

11. The system according to any of the preceding claims, wherein the liquid volume tracking component, the coffee tracking component, and the medication tracking component are configured to operate based on the tracked values being provided by user input.

12. The system according to claim 11 , wherein at least one of the liquid volume tracking component, the coffee tracking component, and the medication tracking component are configured to send a notification to the user requesting user input to the tracker.

13. The system according to any of the preceding claims, comprising an urge component, the urge component configured to be activated by the user using a dedicated urge button on a home screen of an application.

14. The system according to claim 13, wherein the urge component is configured to track the user’s urge level and provide the bladder training component with the tracked urge level.

15. The system according to any of the preceding claims, further comprising a questionnaire component, the questionnaire component being configured to present a questionnaire to the user and record the user’s responses to one or more questions contained in the questionnaire.

16. The system according to claim 15, wherein the questionnaire component is configured to present at least one of the questionnaires: during a user onboarding process; and in preparation to a doctor visit.

17. The system according to claim 15 or 16, the questionnaires presented by the questionnaire comprising at least one of: an onboarding questionnaire for general medical assessment; an urge level questionnaire; a before interim doctor visit questionnaire; a before follow-up doctor visit questionnaire; a quality of life questionnaire; an after interim doctor visit questionnaire; an ICIQ-UI-SF questionnaire; a bowel movement assessment questionnaire; a feedback questionnaire.

18. The system according to any of claims 15 to 17, wherein the questionnaire component is configured to provide previously completed questionnaires to the users, wherein the questionnaire component preferentially allows user’s review, comparison and/or editing of previously completed questionnaires.

19. The system according to any of the preceding claims, further comprising a standardized tests component, the standardized tests component being configured to assist the user in completing standardized tests, in particular at least one of an urine loss pad test and a bladder protocol test.

20. The system according to claim 19, wherein the standardized test component is configured to generate one or more interfaces allowing the user to: review how to take the standardized test; answer all questions of the standardized test; submit responses to the standardized test; and allow finishing the test later, in particular in cases where the test assumes data captured for several days as for the bladder protocol.

21. The system according to any of claims 19 to 20, wherein the standardized test component is configured to provide previously completed tests to the users, wherein the standardized test component preferentially allows user’s review, comparison and/or editing of previously completed tests.

22. The system according to any of the preceding claims, further comprising a notification component for notifying the user, the notification component implementing at least one of, preferably all of, in-app notifications, reminder notifications, and email notifications based on notification types.

23. The system according to any of the preceding claims, further comprising an engagement component, the engagement component being configured to support the user in alleviating incontinence symptoms, wherein the engagement component comprises at least one of a segmentation and positioning subcomponent, a reward subcomponent, and a digital companion mascot subcomponent providing event- and rule-based suggestions, reminders, instructions and engaging emotional facial expressions.

24. The system according to claim 23, wherein the engagement component comprises the segmentation and positioning subcomponent, the segmentation and positioning subcomponent being configured to generate a segmentation over a plurality of users with regard to the overall adherence score and to classify the obtained overall adherence result of the user with the generated segmentation.

25. The system according to claim 23, wherein the segmentation and positioning subcomponent is configured to generate the segmentation with regard to age groups of users and for each week of using the system.

26. The system according to any of claims 23 to 25, wherein the engagement component comprises the digital companion mascot subcomponent, the digital companion mascot subcomponent being configured to indicate the user’s behaviour such as whether the user is doing good in terms of tracking data, adherence, and/or exercises, using emotions of an animated mascot presented to the user.

27. The system according to any of claims 23 to 26, wherein the engagement component comprises the reward subcomponent, the reward subcomponent comprising a reward earning and a reward spending function, the reward earning function being configured to award reward to the user for providing data, in particular for entering data to at least one of the liquid volume tracking component, the coffee tracking component, and the medication tracking component, wherein the amount of reward increases with consecutive adherence to providing data by the user, the reward spending function being configured to donate a monetary amount to a selectable entity, in particular a charity organization, in accordance with the amount of reward awarded to the user.

28. The system according to a combination of claim 4 and 24 or 25, the progress report component further comprising a position report subcomponent being configured to generated an interface indicating the user’s position relative to a relevant control group of users based on the generated segmentation and the classified overall adherence result by the segmentation and positioning subcomponent.

29. The system according to any of the preceding claims, wherein the medication tracking component is configured to track user intake of one or more medications comprising an active substance selected from the list consisting of: trospium chloride, solifenacin, propiverine, mirabegron, oxybutynin, duloxetine, fesoterodine, desfesoterodine, tolterodine, darifenacin, desmopressin, imipramine, cucurbita pepo L., botulinum toxin, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin, ephedrine, phenylpropanolamine, midodrine, ascorbic acid, flavoxate, plantago major, vaccinium macrocarpon, populus tremuloides.

30. The system according to any of the preceding claims, wherein the pelvic floor exercises component is configured to provide the user with a course of pelvic floor trainings, the course consisting of different phases depending on the time after first usage of the user, wherein the content provided to the user is adapted according to the current phase of the course.

31 . The system according to claim 30, wherein the advancing of phases is dependent on the user’s completion of required trainings.

32. The system according to claim 31 , wherein the phases include, in order, a base phase, a strength phase, an endurance phase, and a strength and endurance phase, wherein preferably the base phase is separated into a first part taking place from day 1 to day 3 and a second part taking place from day 4 to day 7, the strength phase takes place from day 8 to 28, the endurance phase takes place from day 29 to 49, and the strength and endurance phase takes place from day 50 to 84, wherein the length of the phases is a minimum duration and is adjusted appropriately dependent on the user’s completion of required trainings.

33. The system according to claim 32, wherein the first part of the base phase includes presenting a first content, a second content and a third content to the user directed at supporting the user to feeling their pelvic floor muscles and learning how to contract them, the second part of the base phase includes presenting the second content, the third content and a fourth content to the user, the strength phase includes presenting a fifth content, a sixth content, and a seventh content to the user directed at supporting the user to strengthen the pelvic floor muscles, the endurance phase includes presenting an eighth content, a ninth content, and a tenth content to the user, and the strength and endurance phase includes presenting, in accordance with a user selection, one of the second content, the fifth content, the eighth content, and an eleventh content, presenting, in accordance with a user selection, one of the fourth content, the sixth content, the ninth content, and a twelfth content, and presenting, in accordance with a user selection, one of the seventh content, the tenth content, and a thirteenth content to the user.

34. The system according to claim 33, wherein one, more or all of the first to thirteenth content is video content explaining specific pelvic floor training exercises, wherein the first and second content and the third and fourth content relate to the same pelvic floor training exercise, respectively.

35. The system according to claim 33 or 34, wherein the pelvic floor exercises component includes, after presentation of content, a notification instructing the user of performing the exercise described in the presented content as a training.

36. The system according to claim 35, wherein the pelvic floor exercises component determines that the daily training is completed if two exercises are performed by the user, wherein in particular the pelvic floor exercises component in the strength and endurance phase determines that the daily training is completed, if two extended trainings consisting of completing the training two times in a row are performed at least twice per week.

37. The system according to claim 36, wherein the adherence evaluation component is configured to determine the adherence score from the pelvic floor exercises component based on the history of days with completed training.

38. The system according to any of claims 30 to 37, wherein the pelvic floor exercises are grouped according to a) lying exercises, b) sitting exercises, and c) standing exercises; and according to i) breathing exercises, ii) power exercises, iii) endurance exercises, and iv) freestyle exercises.

39. The system according to any of the preceding claims, wherein the bladder training component is configured to provide intervention exercises to the user for supporting the user to overcome sudden urinary urge.

40. The system according to any of the preceding claims, wherein the bladder training component is configured to provide at least one of the following exercises to the user: a memory game, a breathing/meditation exercise, a muscle tension exercise, a visual game (“find”), a geometric game (“order”), and a runner game.

41 . The system according to a combination of claims 24 and 40, wherein the bladder training component is configured to present a full list of selectable exercises but provide a target time for playing, depending on the tracked urge level.

42. The system according to claim 40 or 41 , wherein the runner game is designed to educate the user subconsciously by incentivizing favourable behaviour and penalizing unfavourable behaviour in regard to their recommended behavioural change, in particular by penalizing coffee symbol collection and by incentivizing a meditation symbol collection.

43. The system according to any of the preceding claims, wherein the system is configured to correlate liquid consumption, caffeine containing drinks consumption, and micturition over time in a single diagram to demonstrate the impact of the system on alleviating incontinence symptoms of a user.

44. Computer program product, in particular smartphone app downloadable via the Internet, implementing the system according to any of the preceding claims.

45. Medicament comprising or consisting of an active substance selected from the list consisting of: trospium chloride, solifenacin, propiverine, mirabegron, oxybutynin, duloxetine, fesoterodine, desfesoterodine, tolterodine, darifenacin, desmopressin, imipramine, cucurbita pepo L., botulinum toxin, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin, ephedrine, phenylpropanolamine, midodrine, ascorbic acid, flavoxate, causticum hahnemanni, plantago major, vaccinium macrocarpon, populus tremuloides for use in a method for treating or preventing overactive bladder syndrome and incontinence symptoms of a patient, in particular at least one of reduction of micturitions and reduction of urine loss, the method comprising using the system according to any one of claims 1 to 43 or the computer program product according to claim 44.