RU2849238C1 - Method for preventive therapy of severe genital prolapse in patients of risk group in health resort environment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to gynaecology, and can be used in the practice of balneal surgeons, obstetrician-gynaecologists specializing in pelvic floor dysfunction. Method uses a mathematical prediction model, which includes significant risk factors of pathology: female body weight index, 2 or more deliveries, perineal ruptures, varicose vein disease, iron-deficiency anaemia, place of residence (urban or countryside) in the past medical history. Using a multivariate analysis, a logistic regression technique is used to define a risk group of developing severe genital prolapse. Patients of risk group are diagnosed with early manifestations of pelvic floor dysfunction, ultrasonography, pelvic floor muscle strength by means of digital perineometer, questioning by means of questionnaire FSFI 19, that is sexual function index. Preventive therapy is carried out, including correction of personalized modified risk factors of developing severe pelvic prolapsed, a complex of natural and artificial physical factors, mineral and phytotherapy, restorative technologies aiming at strengthening the pelvic muscles.

EFFECT: method provides improving the female’s quality of life ensured by the early prediction of developing severe pelvic prolapsed and the implementation in the health resort environment.

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Description

The proposed invention relates to medicine, namely to gynecology, and can be used to perform early correction of modifiable risk factors for pelvic floor dysfunction in a sanatorium setting based on a formula for predicting severe genital prolapse in women of reproductive age.

Pelvic organ prolapse (POP) is a condition in which the pelvic organs shift from their normal anatomical position and/or prolapse beyond the vaginal opening. The exact prevalence of this condition is difficult to determine given the intimate nature of the problem. Barber M.D. reports that among patients seeking routine gynecological care, women with genital prolapse make up 30 to 76%. (Barber MD. Pelvic organ prolapse. BMJ. 2016. 20; 354: i3853. https://doi: 10.1136/bmj.i3853).

The initial forms of the disease are usually not accompanied by alarming symptoms and remain undiagnosed. Severe prolapse requires surgical treatment. The complication rate of surgical treatment using synthetic materials during long-term follow-up reaches 42% [Mangir N., Roman S., Chappie C.R. et al. Complications related to the use of mesh implants in surgical treatment of stress urinary incontinence and pelvic organ prolapse: infection or inflammation? // World. J. Urol. 2020. Vol. 38, N 1. P. 73-80.], infectious complications are observed in approximately 1% of cases [Mangir N, Roman S, Chappie CR, MacNeil S. Complications related to the use of mesh implants in surgical treatment of stress urinary incontinence and pelvic organ prolapse: infection or inflammation? World. J. Urol. 2020; 38(1): 73–80], and the average recurrence rate after surgical correction using various methods (hysterectomy, suspension of the uterosacral and sacrospinous ligaments, sacrocolpopexy, suburethral sling, anterior vaginal wall repair using mesh) is 36% [Friedman T, Eslick GD, Dietz HP. Risk factors for prolapse recurrence: systematic review and meta-analysis. Int. Urogynecol. J. 2018; 29(1): 13–21.].

It is known that during childbirth, trauma and disruption of the innervation of the pelvic floor muscles occur, which is a predisposing factor for the development of prolapse. Women who have had two pregnancies are 8.4 times more likely to require surgical treatment for pelvic organ prolapse than women who have had one child. Russian authors classify varicose veins as a manifestation of clinical and functional syndromes of connective tissue dysplasia. Women with connective tissue disorders are known to be predisposed to developing POP.

The development of informative methods for predicting and early correction of POP will contribute to the prevention of severe forms of the disease, help avoid surgical treatment, and significantly improve the quality of life of women of reproductive age.

A method for predicting genital prolapse in women is known, which consists in selecting biomaterial for DNA extraction, conducting DNA genotyping using the tetra-primer allele-specific PCR reaction, characterized by the detection of polymorphism of the FBLN5 gene at the rsl2586948 and rs2018736 sites, while a high degree of risk of developing PG is predicted in the presence of alleles of single-nucleotide variants rsl2586948-A and / or rs2018736-C, and a reduced degree of risk - in the presence of alleles of single-nucleotide variants rsl2586948-G and / or rs2018736-A. (patent RU 2542441 C1 dated 09.25.2013). The disadvantage of this method is that it requires obtaining a vaginal tissue sample to conduct the study, which is an invasive method and limits its use in the routine practice of a gynecologist.

A known method of conservative treatment for patients with uterine prolapse involves bimanual uterine repositioning (patent RU 2 716 367). Circular kneading, pressing, and stretching movements target the piriformis muscles, infundibulopelvic ligaments, and parametrial tissue. Then, thrusting pressure movements target the origin and insertion of the piriformis muscles, subsequently shifting the uterus to the right and left. The uterus is then repositioned cranially.

Genital prolapse is a multifactorial condition. This approach focuses on short-term effects on the pelvic muscles and ligaments, but lacks a comprehensive approach to correcting pelvic floor insufficiency that considers the possible causes of the condition.

The authors propose a method for predicting and providing preventive therapy for severe genital prolapse in women of reproductive age in a sanatorium setting. This method is based on identifying a risk group through mathematical modeling of the risk prognosis for severe pelvic organ prolapse, taking into account clinical and anamnestic factors (body mass index, two or more pregnancies, history of perineal rupture, varicose veins of the lower extremities, iron deficiency anemia, place of residence (city/village), early diagnosis of pelvic floor muscle dysfunction, a set of spa treatment methods aimed at correcting modifiable risk factors for pelvic floor dysfunction, and a 12-day course of preventive therapy (Altai Castle Sanatorium, Federal Resort Town of Belokurikha, Altai Krai, Russian Federation).

This method is non-invasive, safe, and technically simple.

The technical result of the method proposed by the authors is an improvement in the quality of life of women due to the early prediction of the development of severe pelvic organ prolapse and the implementation, in a sanatorium setting, of early correction of modifiable risk factors and a course of preventive therapy for pelvic organ dysfunction, including natural and artificial physical factors, mineral and phytotherapy, and restorative technologies.

The method is carried out in two stages (diagnostic and therapeutic):

At the diagnostic stage, women undergo anamnesis collection and an assessment of the following factors: body mass index, history of 2 or more births, presence of perineal lacerations during childbirth, varicose veins of the lower extremities, iron deficiency anemia, and living conditions (city or village).

The selection of the above indicators as risk factors for severe genital prolapse was confirmed using binary logistic regression analysis. Two groups of patients were examined during the development of the proposed method. The first group included 66 women aged 18-45 years who had undergone surgery for grades 3-4 genital prolapse. The second group included 68 women aged 18-45 years who did not have pelvic organ prolapse. The obtained values were used in a mathematical model to determine the risk of severe genital prolapse.

z=-6.403+0.14CHIMT+4.02HRP+1.8HKR+1.48HUP+2.9HVB+3.9HZhDA

where e is Euler's constant ≈2.718281,

p is a prognostic index characterizing the probability of severe genital prolapse, BIMT is a body mass index (kg/m2), CRP is perineal ruptures (0 - no ruptures, 1 - ruptures were present), NBP is the number of births 2 or more (0 - no, 1 - yes), LCC is living conditions (0 - city, 1 - village), VCVL is varicose veins of the lower extremities (0 - no, 1 - yes), IDA is iron deficiency anemia (0 - no, 1 - yes).

Substituting the required data into each formula yields the final result. A p-value of 43.3 or greater predicts the development of severe genital prolapse.

The resulting regression model is statistically significant (p < 0.001). Based on the Nigelkirk coefficient of determination, the model accounts for 64.6% of the factors determining the likelihood of developing a severe form of the disease. To improve the model's diagnostic effectiveness, we adjusted the classification threshold based on the results of the ROC curve analysis.

The threshold value was 43.3%. A p-value of 43.3% or greater predicts the risk of severe genital prolapse. The model's sensitivity was 83.3%, and its specificity was 88.2%.

Thus, the patients’ belonging to the high or low risk group for the development of severe POP was determined based on the calculated values of the diagnostic regression function: with a prognostic index value of 43.3% or more, a woman belonged to the high risk group for the development of severe POP, and with a function value of less than 43.3%, she belonged to the low risk group.

The diagnostic block includes: collecting anamnesis with determination of risk factors for the development of POP, which are then included in the mathematical model developed by the authors (built on the basis of multivariate analysis using the logistic regression method), the use of which allows with a high degree of probability (sensitivity 83.3%, specificity 88%) to predict the development of severe genital prolapse in women of reproductive age; In women at high risk of developing severe POP, the condition of the pelvic floor organs is assessed (Algorithm for early diagnosis of pelvic floor insufficiency 5 STEPS (Dikke G.B., 2018): S - look (what the perineum looks like), T - test (Valsalva maneuver), E - test again (cough test), P - palpate, S - ask about symptoms), ultrasound examination, assessment of the strength of the pelvic floor muscles using a digital perineometer, questioning using the FSFI 19 questionnaire - sexual function index), ultrasound examination, the tone and strength of the pelvic floor muscles are determined using a digital perineometer.

The technical result is achieved by determining the following factors in women of reproductive age: living conditions (city or village), body mass index, 2 or more births in the anamnesis, the presence of perineal lacerations during childbirth, varicose veins of the lower extremities, iron deficiency anemia, which are entered into a mathematical formula that determines the degree of risk of POP.

Further, in order to achieve early correction of modifiable risk factors and early correction of pelvic organ dysfunction, a preventive complex of spa treatment methods (therapeutic block) is carried out.

The therapeutic block includes measures that eliminate modifiable risk factors:

a) aimed at reducing body weight, normalizing the function of the gastrointestinal tract (eliminating constipation):

- a balanced low-calorie diet of 1600 kcal/day with meals 5 times a day at the Altai Castle sanatorium;

- daily intake of mineral water (200 ml once a day at lunch) - medicinal table water, low-mineralized, chloride-hydrocarbonate-sulphate, calcium-sodium with a slightly alkaline reaction "Belokurikha Vostochnaya No. 2" (Balneological conclusion No. 1076 of 07/29/2013 of the Federal State Budgetary Institution of Science TNIIKiF FMBA of Russia on the water of well No. A-24\70 (Solonovskoye occurrence of the Berezovsky deposit, Ust-Kalmansky district, Altai Krai);

- phytotherapy, represented by briquetted tea drinks "Alfit" and "Fitol" from the scientific and production company "Alfit" and "Alfit+" (Pharmaceutical plant "Galen", Barnaul, Altai Territory, Russian Federation):

- Fitol-3 "For weight loss" 1 capsule 2 times a day during meals (state registration certificate ru.77.99.88.003. E 010789.11.14 dated 11/17/2014)

- tea drink "Alfit-16 - for weight loss" (state registration certificate RU.77.99.11.003.E.029904.06.11 dated June 17, 2011). Method of preparation and administration: 200 ml morning/evening of freshly prepared tea drink, which is brewed with water at a temperature of 90C and drunk after 20 minutes.

b) aimed at strengthening the pelvic floor muscles: physical (terrain cures, aqua aerobics, exercise therapy/Qigong, Kegel exercises) and physiotherapeutic techniques (electromagnetic stimulation of the neuromuscular apparatus of the pelvic floor on the KAP-ELM-01 “Andro-Gyn” device), gynecological irrigation with radon water;

- terrain cure routes of the Altai Castle sanatorium in combination with Nordic walking (individual selection of mileage) - daily;

- Aqua aerobics - 30 minutes every other day, 6 sessions, alternating with exercise therapy sessions of 30 minutes each for 6 days, or (according to individual indications) Chinese health gymnastics sessions “Qigong” for 45 minutes

- training and development of a method for training the pelvic floor muscles using Kegel exercises according to a well-known technique (Bezhenar V.F., Dikke G.B., Glukhov E.Yu. Pelvic floor insufficiency. Therapy based on the achievements of science and clinical practice. Moscow: Publishing house "ABV-press", 2021. Pp. 193-195);

- electromagnetic stimulation of the pelvic floor neuromuscular apparatus using the KAP-ELM-01 Andro-Gyn device was performed daily. The patient was positioned supine. A cavity electrode was inserted into the posterior vaginal fornix, and a 6x9 cm plate electrode was placed horizontally in the suprapubic region. The stimulation was performed using bursts (6 sec excitation, 2 sec pause) of asymmetrical biopolar pulses alternating 10 min of positive and negative polarity; mode 3; frequency 10 Hz; deviation 20%. The amplitude was determined individually based on the painlessness of inward vibration sensations and/or contractions of the anterior abdominal wall muscles. The total duration of the procedure was 20 min. The course of therapy consisted of 10 procedures.

- gynecological irrigation with radon water No. 10.

The proposed preventive therapy method for female patients at risk for severe genital prolapse, based on a comprehensive assessment of clinical and anamnestic risk factors, can be used in a sanatorium setting through early correction of modifiable risk factors. This personalized approach allows for rapid (12 days) improvement of pelvic floor muscle tone, reduction of early symptoms of pelvic floor dysfunction (discomfort, air entering the vagina while walking and exercising, episodes of stress urinary incontinence, and bowel dysfunction), improvement of sexual function, and enhancement of quality of life. The presented method is easy to implement, cost-effective, and will find wide application in sanatorium and resort practice.

The effectiveness of the claimed method is confirmed by the following clinical examples.

Case Study 1. Patient A., 32, city resident. Examined by an obstetrician-gynecologist at the Altai Castle Sanatorium. History: one full-term vaginal delivery in October 2020. Perineal lacerations during childbirth. Weight: 80 kg, height: 165 cm, BMI: 29.4 kg/ ^m² . Somatic pathology: chronic gastritis, iron deficiency anemia. Complaints of perineal discomfort, air entering the vagina during intercourse, and rare episodes of urinary incontinence when coughing. Attempted to perform Kegel exercises independently. Objectively: gaping of the genital slit at rest and during the Valsalva maneuver. Ultrasound results revealed grade 1 anterior vaginal wall prolapse (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure). The Female Sexuality Function Index (FSFI) questionnaire showed a score of 23 (an index of less than 26.5 indicated sexual dysfunction). Perineometry using a digital perineometer showed a score of 2 (very weak pelvic floor muscle contractions). Using these data, a preliminary risk estimate for severe POP was made for this patient.

z=-6.403+0.14*29.4+4.02*1+1.8*0+1.48*0+2.9*0+3.9*1=5.577

The value of the prognostic index was

This value exceeds 43.3%, which, according to the claimed method, indicates a high risk of developing severe POP in this woman.

Given the high risk of severe genital prolapse, the woman was offered preventive therapy at the Belokurikha resort. The following was prescribed for weight loss: a low-calorie diet, daily mineral water intake, and herbal medicine. Given the weakness of the pelvic floor muscles, the patient was recommended a course of strengthening therapy: electromagnetic stimulation of the pelvic floor neuromuscular apparatus using the KAP-ELM-01 Andro-Gin device (10 procedures); gynecological irrigation with radon water No. 10; Kegel exercises using a perineometer, and the terrain cure routes of the Altai Castle resort combined with Nordic walking - daily; Aqua aerobics - 30 minutes every other day, 6 procedures, alternating with 30-minute exercise therapy sessions for 6 days. After the course, the woman was advised to follow a low-calorie diet and continue doing Kegel exercises daily.

The patient was examined after completing a course of preventive therapy. She weighed 78 kg, and her BMI was 28.7 kg/ ^m2 . During the interview, she reported no episodes of urinary leakage or discomfort during sexual intercourse. Objectively, the genital slit was gaping during the Valsalva maneuver; at rest, the genital slit remained unchanged. Ultrasound revealed grade 1 prolapse of the anterior vaginal wall (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure). The Female Sexuality Function Index (FSFI) questionnaire showed a score of 27 (no sexual dysfunction). Perineometry using a digital perineometer resulted in a score of 3 points (weak pelvic floor muscle contractions).

Results of examination three months after the course of therapy: weight 75 kg, BMI 27.5 kg/ ^m2 , no complaints. Objectively: the external genitalia are formed correctly. According to the ultrasound results: prolapse of the anterior vaginal wall of grade 1 (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure). Results of the questionnaire using the Female Sexuality Index (FSFI) - 30 (absence of sexual dysfunction). Results of perineometry using a digital perineometer - 4 points (weak contractions of the pelvic floor muscles).

Results of examination 6 months after the course of therapy: weight 70 kg, BMI 25.7 kg/ ^m2 , no complaints. Objectively: the external genitalia are formed correctly. According to the ultrasound results: prolapse of the anterior vaginal wall of grade 1 (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure). Results of the questionnaire using the Female Sexuality Index (FSFI) - 30 (absence of sexual dysfunction). Results of perineometry using a digital perineometer - 4 points (weak contractions of the pelvic floor muscles).

Case Study 2. Female patient P., 44 years old. Rural resident. Examined by an obstetrician-gynecologist at the Altai Castle Sanatorium. History of two urgent vaginal deliveries. Perineal lacerations in the first birth. Weight 78 kg, height 168 cm, BMI -27.6 kg/ ^m2 . Somatic pathology: varicose veins of the lower extremities, chronic hemorrhoids, myopia. Complaints of episodes of urinary incontinence with sudden movements, coughing, and laughing. Objectively: gaping of the genital slit at rest and during the Valsalva maneuver. Ultrasound results: prolapse of the anterior vaginal wall grade II (dislocation and hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure, signs of insufficiency of the internal urethral sphincter). The Female Sexuality Index (FSFI) questionnaire showed a score of 20 (an index of less than 26.5 indicated sexual dysfunction). Perineometry using a digital perineometer showed a score of 3 (very weak pelvic floor muscle contractions). Using these results, a preliminary risk estimate for severe pelvic floor dysfunction was made for this patient.

z=-6.403+0.14*27.6+4.02*1+1.8*1+1.48*1+2.9*1+3.9*0=-2.023

The value of the prognostic index was

This value exceeds 43.3%, which, according to the claimed method, indicates a high risk of developing severe POP in this woman.

Given the high risk of severe genital prolapse, the woman was offered preventive therapy at the Belokurikha resort. For weight loss, the following was prescribed: a low-calorie diet, daily mineral water intake, and herbal medicine (Fitol-3 "For weight loss", 1 capsule 2 times a day with meals). To strengthen the pelvic floor muscles, the following was recommended: electromagnetic stimulation of the pelvic floor neuromuscular apparatus using the KAP-ELM-01 "AndroGin" device (10 procedures); gynecological irrigation with radon water No. 10; Kegel exercises using a perineometer, and daily terrain paths along the Altai Castle resort routes combined with Nordic walking; 45-minute classes in Chinese health gymnastics "Qigong." After the course, the woman was advised to follow a low-calorie diet and continue doing Kegel exercises daily.

Results of the patient's examination after the completed course of preventive therapy: Weight 75 kg, BMI 26.6 kg/ ^m2 . During the survey, she noted a decrease in the frequency of episodes of urinary leakage with sudden movements, coughing, and laughing. Objectively: gaping of the genital slit at rest and during the Valsalva maneuver. According to the ultrasound results: prolapse of the anterior vaginal wall of grades I-II (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure, signs of insufficiency of the internal urethral sphincter). The results of the questionnaire using the Female Sexuality Index (FSFI) are 24 (persistent manifestations of sexual dysfunction). The results of perineometry using a digital perineometer are 4 points (weak contractions of the pelvic floor muscles).

Results of the patient's examination after 3 months: Weight 72 kg, BMI 25.5 kg/ ^m2 . During the survey, she noted a decrease in the frequency of episodes of urine leakage with sudden movements, coughing, and laughing. Objectively: gaping of the genital slit at rest and during the Valsalva maneuver. According to the results of the ultrasound: prolapse of the anterior vaginal wall of the first degree (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure, signs of insufficiency of the internal urethral sphincter). The results of the questionnaire using the Female Sexuality Index (FSFI) are 28 (absence of sexual dysfunction). The results of perineometry using a digital perineometer are 4 points (weak contractions of the pelvic floor muscles).

Results of examination 6 months after the course of therapy: weight 69 kg, BMI 24.4 kg/ ^m2 , complaints of rare episodes of urine leakage when coughing. Objectively: gaping of the genital slit. According to the results of ultrasound: prolapse of the anterior vaginal wall of the first degree (hypermobility of the urethrovesical segment in response to increased intra-abdominal pressure, signs of insufficiency of the internal urethral sphincter). Results of the questionnaire using the Female Sexuality Index (FSFI) - 30 (absence of sexual dysfunction). Results of perineometry using a digital perineometer - 4 points (weak contractions of the pelvic floor muscles).

Thus, patients with a high risk of developing severe genital prolapse showed a positive effect after a course of therapy at the Altai Castle sanatorium. To maintain and improve the achieved results in strengthening the pelvic floor muscles, it is recommended to repeat the course of preventive therapy. The therapy interval will depend on the woman's condition (once every 6 or 12 months) [Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106].

A significant advantage of this method is its non-invasive nature and ease of use, combined with high diagnostic accuracy (88%). It is non-invasive, has no contraindications, and has been clinically validated.

Claims (19)

A method for preventive therapy of severe genital prolapse in high-risk female patients in a sanatorium setting, characterized by the fact that risk factors are initially identified in the patient: living conditions, body mass index, 2 or more births in the anamnesis, the presence of perineal ruptures during childbirth, varicose veins of the lower extremities, iron deficiency anemia, then the prognostic index (ρ) is calculated z=-6.403+0.14CHIMT+4.02HRP+1.8HKR+1.48HUP+2.9HVB+3.9HZhDA, where e is Euler's constant, equal to 2.718281, BIMI - body mass index kg/ ^m2 , HRP - perineal ruptures: 0 - there were no ruptures, 1 - there were ruptures, HCR - number of births 2 or more: 0 - no, 1 - yes, HUP - living conditions: 0-city, 1-village, VVD - varicose veins of the lower extremities: 0 - no, 1 - yes, IDA - iron deficiency anemia: 0-no, 1-yes, and if the ρ value is 43.3% or more, the risk of developing severe genital prolapse is predicted and therapy is carried out to eliminate modifiable risk factors, namely: diet 1600 kcal/day with meals 5 times a day at the Altai Castle sanatorium; daily intake of mineral water 200 ml once a day at lunch - medicinal table water, low-mineralized, chloride-hydrocarbonate-sulfate, calcium-sodium with a slightly alkaline reaction "Belokurikha Vostochnaya 2"; phytotherapy, represented by briquetted tea drinks "Alfit" and "Fitol" from the scientific and production company "Alfit" and "Alfit+": Fitol-3 "For weight loss" 1 capsule 2 times a day during meals and "Alfit - 16 - for weight loss" 200 ml morning / evening of freshly prepared tea drink, which is brewed with water at a temperature of 90 ° C and drunk 20 minutes after preparation; terrain cures along the routes of the Altai Castle sanatorium in combination with Nordic walking with individual selection of mileage - daily; aqua aerobics for 30 minutes every other day for 6 sessions, alternating with exercise therapy sessions for 30 minutes for 6 days or Chinese health gymnastics classes “Qigong” for 45 minutes; training and practicing the method of training the pelvic floor muscles using Kegel exercises; Electromagnetic stimulation of the pelvic floor neuromuscular apparatus using the KAP-ELM-01 Andro-Gyn device is performed daily. The patient is positioned supine, a cavity electrode is inserted into the posterior vaginal fornix, a 6 x 9 cm plate electrode is placed horizontally in the suprapubic region, and bursts of excitation are applied - 6 sec, pause - 2 sec, with asymmetrical biopolar impulses alternating for 10 minutes with positive and negative polarity; mode 3; frequency 10 Hz; deviation 20%, the amplitude is determined individually, focusing on the painlessness of vibration sensations, the total duration of the procedure is 20 minutes, the course of therapy is 10 procedures; Gynecological irrigation with radon water is carried out in 10 procedures.