RU2844409C1 - Method for robot-assisted laparoscopic colposuspension using a combined sling prosthesis for stress urinary incontinence in women - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: invention refers to medicine, namely to obstetrics and operative gynaecology. Laparoscopic trocars are inserted. That is followed by entering the Retzius space and dividing the subcutaneous tissue spaces, performing a colpopexy, and closing the Retzius space. Robotic complex da Vinci Xi is used, trocars are installed, as shown in Fig. 1, optical trocar – R0 in paraumbilical region, first 8 mm robotic trocar – scissors R1 – along the right midclavicular line, second 8 mm robotic trocar – bipolar ligation clamp R2 – is installed along the left midclavicular line, third robotic 8 mm trocar – clamp graber R3 – on left 5 cm in the medial direction from spina iliaca anterior superior, 12 mm assistant trocar As1 is placed on right 5 cm above spina iliaca anterior superior. Using scissors R1, the vagina is dissected in longitudinal direction 2 cm below the urethra at distance of 5-6 cm, then vagina is separated at level of posterior pubourethral ligament, perforation is formed within a pubourethral ligament into a Retzius space. Then, with the help of a bipolar ligation clamp R2 and a clamp grabber R3, the ends of the combined sling prosthesis consisting of polypropylene mesh 300×11 mm, which is cut in middle, "Alloplant" allograft having size of 100×11 mm is anchored in the middle to the mesh. In this case, the anastomosis zone of the polypropylene mesh and the "Alloplant" allograft is 20 mm on each side, and the total length of prosthesis is 360 mm, wherein prosthesis tension is adjusted to achieve pressure on urethra while urine retention during cough test. Introduced through the perforation into the Retzius space from both sides, by the ends the sling prosthesis is drawn into the Retzius space and placed under the urethra, with the help of R1, in which the scissors are previously changed to the needle holder, prosthesis is fixed to Arcus tendineus musculi levatoris ani, then prosthesis ends are fixed to Cooper's ligament from both sides.

EFFECT: method provides the higher therapeutic effect ensured by the posterior pubourethral ligament repair and the pelvic floor reinforcement.

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Description

The invention relates to medicine, namely to obstetrics and gynecology, and can be used to treat urinary incontinence in women.

Urinary incontinence, a common and often debilitating problem, affects many adult women [Comparative study of two techniques of laparoscopic burch colposuspension using sutures versus mesh in women with genuine stress urinary incontinence Basheer N. Elmohamady, Hammouda W. Sherif, Shabieb A. Mohammed, Ahmed H. Mohamed &Abdallah F. Abdelazim Pages 121–128 | Received 10 Dec 2023, Accepted 17 Feb 2024, Published online: 07 Mar 2024].

This condition occurs due to a complex interaction between the pelvic floor, bladder, urethra, sphincter, and the neurological system that controls these organs. Damage to any of these components can lead to urinary incontinence [Dean N, Ellis G, Herbison GP. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev. 2017;2017 (open in a new window)(7(open_in_a_new_window)): Cd002239. doi: 10.1002/14651858.CD002912.pub7].

Up to 13.6% of women will undergo surgical treatment for stress urinary incontinence during their lifetime. Midurethral slings are the mainstay of treatment for stress urinary incontinence; however, a variety of surgical options is needed to accommodate the large number of patients seeking treatment [Robotic Burch colposuspension: anatomical and technical considerations. Tappy E, Pan E, Corton M. Int Urogynecol J. 2023 Jul;34(7): 1653-1657. doi: 10.1007/s00192-023-05452-1. Epub 2023 Feb 6. PMID: 36745132].

Surgical treatment of urinary incontinence using a polypropylene prosthesis is the most common surgical intervention for the correction of stress urinary incontinence [Effect of lower urinary tract conditions on surgical outcomes of different suburethral sling procedures for female stress urinary incontinence. Jiang YH, Chen SF, Kuo HC. Int Urol Nephrol. 2024 Sep;56(9):2905-2912. doi: 10.1007/s11255-024-04047-z. Epub 2024 Apr 13].

A method of loop urethral plasty using a mesh endoprosthesis for stress urinary incontinence in women is known, characterized by the fact that the mesh endoprosthesis is installed in the retropubic pubovaginal space. A vertical vaginal incision 3-4 cm long is made 2.5 cm below the urethra in the direction of the cervix, after which a step-by-step separation of 4 cm is performed. The mesh endoprosthesis is installed through the vagina under the urethra, the ends are brought out to the anterior abdominal wall. At the end of the procedure, the bladder is filled and cystoscopy is performed. Cystoscopy is performed to confirm the absence of bladder damage and to ensure that the ureters perform their drainage function. A Foley catheter is installed after surgery to drain the bladder [Effect of lower urinary tract conditions on surgical outcomes of different suburethral sling procedures for female stress urinary incontinence. Jiang YH, Chen SF, Kuo HC. Int Urol Nephrol. 2024 Sep;56(9):2905-2912. doi: 10.1007/s11255-024-04047-z. Epub 2024 Apr 13].

In 2019, the US Food and Drug Administration banned the production of transvaginal mesh for prolapse. This ban may affect the use of synthetic meshes for the treatment of incontinence in the future [Sedrakyan, A. Chughtai, V. Mao, J Regulatory warnings and use of surgical mesh in pelvic organ prolapse JAMA Intern Med. 2016; 176:275-277]. One of the disadvantages of the technique of using a mesh prosthesis for stress urinary incontinence is the high incidence of difficulty urinating - up to 22% [Alcalay, M. Monga, A. Stanton, SL Burch colposuspension: a 10-20 year follow up Br J Obstet Gynaecol. 1995; 102:740-745]

Despite surgical effectiveness, implant-associated complications were observed in the form of erosions of the vagina, bladder or urethra, wrinkling and infection of the prostheses, as well as stress urinary incontinence occurring de novo and recurrence of stress urinary incontinence [Bezhenar V.F., Bogatyreva E.V., Tsypurdeeva A.A., Tsuladze L.K., Rusina E.I., Guseva E.S. New Possibilities of Surgical Correction of Pelvic Prolapse Using Synthetic Implants: Ways to Prevent Postoperative Complications. Obstetrics. Gynecology. Reproduction. 2012; 6(2): 6-13].

In connection with these circumstances, in search of an effective way to treat patients with stress urinary incontinence without the use of any synthetic prostheses, gynecologists returned to the Burch colposuspension developed 60 years ago.

The Burch colposuspension aims to elevate the bladder neck and proximal urethra back into the area of intra-abdominal pressure behind the pubic symphysis. This elevation allows for a significant improvement in pressure transmission to the urethra. According to Riess and colleagues, the Burch colposuspension increases the functional length of the urethra as well as the urethral closure pressure, which is the reason why no other continence procedure achieves a comparable degree of reliability [Riess P, Ralf G. Abdominal colposuspension - the gold standard for the treatment of urinary incontinence [Geburtshilfe Frauenheilkd. 1994; 54: 69-74.] In addition, the Burch colposuspension simultaneously treats mild forms of anterior wall prolapse (in accordance with Burch's original postulate). Sufficient vaginal mobility and capacity are prerequisites for the success of colposuspension and should be taken into account, especially in patients with previous vaginal interventions [Hampel K., Hohenfellner M., Melchior S., Turoff J.W. Sling-plasty in the treatment of female urinary incontinence. Urologe A. 2001; 40: 274-280.].

The closest analogue of the invention is the method of laparoscopic colposuspension according to Birch [Tan E., Tekkis P.P., Cornish J., Teo T.G., Darzi A.V., Khullar V. Laparoscopic and open colposuspension for urodynamic stress urinary incontinence. Neurourol Urodyn. 2007; 26: 158-169.], which includes the following stages:

Stage 1 - Placement. During laparoscopy, two 10 mm trocars are placed in the midline and two 5 mm trocars are placed in the suprapubic area.

Stage 2 - Entry into the Retzius space. Separation of the fatty tissue along the anterior abdominal wall to the level of the bladder neck is performed. In order to free the bladder neck, the paravaginal tissue is bluntly moved apart. Dissection of the Retzius space to the endopelvic fascia is performed in order to access the cervicourethral region.

Stage 3 - Separation of cellular spaces. This is performed using atraumatic laparoscopic clamps in order to minimize possible trauma to the venous plexuses in this area; if necessary, additional hemostasis is performed using bipolar high-frequency coagulation.

Stage 4 - Colpopexy. Proximal sutures are placed 2-3 cm lateral to the bladder neck, distal sutures are placed 2-3 cm lateral to the proximal third of the urethra. They cover the entire thickness of the vaginal wall, just under the mucous membrane. With the help of an assistant, the vagina is lifted, and the knots are carefully tied over Cooper's ligament without tension. Colpopexy is performed on the contralateral side in the same way.

Stage 5 - Closure of the Retzius space using synthetic absorbable suture material and peritonization.

Stage 6 - The instruments are removed from the abdominal cavity, after sanitizing the abdominal cavity and pelvis, the trocar insertion points are sutured layer by layer.

The disadvantage of the prototype is that it does not achieve complete elimination of the prolapse of the anterior vaginal wall due to the lack of restoration of the posterior pubourethral ligament.

The laparoscopic approach to Burch colposuspension avoids numerous disadvantages associated with open surgery, one of which is the aesthetic aspect regarding the abdominal scar. Minimally invasive techniques generally provide a shorter hospital stay, faster recovery and return to activity [Tan E, Tekkis PP, Cornish J, Teo TG, Darzi AV, Khullar V. Laparoscopic versus open colposuspension for urodynamic stress urinary incontinence. Neurourol Urodyn. 2007; 26: 158-169].

The objective of the invention is to develop a method for robot-assisted laparoscopic colposuspension for stress urinary incontinence in women.

The technical result of using the invention is an increase in the therapeutic effect due to the restoration of the posterior pubourethral ligament and strengthening of the pelvic floor.

The invention is illustrated by the following figures: Figure 1 shows the arrangement of trocars of robot-assisted laparoscopic colposuspension; Figure 2 shows the location of fixation of the sling prosthesis, where: 1 - ligamentum pubicum Cooperi (Cooper's ligament); 2 - Arcus tendineus musculi levatoris ani; Figure 3 - fixation of the combined sling prosthesis 3, front view; Fig. 4 - fixation of the combined sling prosthesis 3, side view.

The use of robot-assisted laparoscopic colposuspension in surgical practice is a priority in patients with obesity, severe adhesions, as well as with recurrent forms of genital prolapse after correction of pelvic organ prolapse with mesh prostheses using both vaginal and laparoscopic approaches.

The proposed method of robot-assisted laparoscopic colposuspension for stress urinary incontinence in women using a combined mesh prosthesis is carried out as follows. The da Vinci Xi robotic complex is used. Trocar installation stage (docking): five trocars are installed. Optical trocar R0 is installed in the periumbilical region. The first robotic 8 mm trocar R1 (scissors) is installed along the right midclavicular line. The second robotic 8 mm trocar R2 (bipolar ligating clamp) is installed along the left midclavicular line. The third robotic 8 mm trocar R3 (grasper clamp) is installed on the left 5 cm medial to the spina iliaca anteri or superior

Then, an assistant 12 mm trocar As1 is placed on the right, 5 cm above the spina iliaca anterior superior (Fig. 1).

The recommended intra-abdominal pressure is 12 mmHg, excess Trendelenburg position is not required. The first stage: in the cutting and coagulation mode to enter the space of Retzius, the median umbilical ligament, vesicoumbilical fascia are dissected with scissors (R1) with preliminary fixation with a bipolar ligating clamp (R2) sequentially in the direction of the pubic bone and Cooper's ligament, laterally in the direction of the external iliac vessels and corona mortis and medially in the direction of the neck of the bladder to the arcus tendineus musculi levatoris ani. At the second stage, the vagina is dissected longitudinally 2 cm below the urethra at a distance of 5-6 cm. Next, the vagina is separated at the level of the posterior pubourethral ligament. A perforation opening into the space of Retzius is formed in the area of the pubourethral ligament. At the third stage, the ends of the combined sling prosthesis are inserted through the perforation hole into the Retzius space on both sides. Using the bipolar ligating clamp (R2) and the grasper clamp (R3), the combined sling prosthesis is pulled by the ends into the Retzius space and placed under the urethra. After installation, using R1, whose scissors are first replaced with a needle holder, the combined sling prosthesis is fixed with non-dissolving sutures to the Arcus tendineus musculi levatoris ani, then the ends of the prosthesis are fixed to Cooper's ligament on both sides (Fig. 2). A combined sling prosthesis is used for the treatment of stress urinary incontinence in women, containing a polypropylene mesh for a sling operation and an Alloplant allograft sewn into the middle, obtained from the broad fascia of the thigh, the polypropylene mesh has dimensions of 300 × 11 mm and is cut in the middle for suturing the Alloplant allograft, which has dimensions of 100 × 11 mm, the anastomosis zone of the polypropylene mesh and the Alloplant allograft is 20 mm on each side, and the total length of the prosthesis is 360 mm, while the prosthesis is designed with the possibility of adjusting its tension until pressure is achieved on the urethra to retain urine during a cough test [patent RU 2825064 dated 08/19/2024].

Using R2 and R1, the operation is completed by closing the Retzius space using synthetic absorbable suture material and peritonization (Fig. 3-4). Colporrhaphy of the anterior vaginal wall is then performed.

Advantages of the proposed method:

• providing additional support to the pelvic floor without tensioning the urethra and bladder neck;

• restoration of the posterior pubourethral ligament;

• prevention of chronic postoperative pain syndrome and erosion of the mesh prosthesis;

paravaginal reconstruction of recurrent prolapse of the anterior vaginal wall in women of reproductive age. The essence of the invention is explained by the following clinical example. Patient N., 58 years old, was admitted with complaints of urinary incontinence when coughing, sneezing, physical exertion, a feeling of a foreign body in the vagina and perineum, vaginal dryness.

History: these complaints have been bothering since 2022. Obesity stage III. Menarche at the age of 13, menstruation lasting 3-4 days, moderate, painless; menstrual cycle - 27 days. Menopause within 4 years. There were a total of 3 pregnancies, which ended in three urgent spontaneous births without complications. Gynecological status: the external genitalia are developed correctly. POP-Q II (Aa-1.5, Ba-1.0, C-5.5, gh3.5, pb3.0, tvl10.0, Ap-2.0, Bp-2.0, D-8.0). An ultrasound examination was performed with a two-dimensional vaginal sensor: the length of the urethra is 1.8 cm, the width of the proximal part of the urethra is 1.6 cm, the urethrovesical angle is 135 degrees.

Uroflowmetry parameters:

Maximum flow rate (Qmax) - 57.5 ml/sec

Volume (V) - 305 ml.

General and bacteriological urine analysis - no abnormalities.

Robot-assisted laparoscopic colposuspension was performed using the proposed method.

In the postoperative period, local treatment, antibacterial, anti-inflammatory therapy were performed. Discharge was carried out on the 3rd day. The condition is satisfactory. After the surgical treatment performed according to the proposed method, after 6 months it was established:

Results of ultrasound examination with a two-dimensional vaginal probe: the length of the urethra is 2.4 cm, the proximal part of the urethra is closed, the urethrovesical angle is 123 degrees. Functional tests: Valsalva test, or straining test and cough test - with a negative answer

Uroflowmetry results:

Qmax - 32.0 ml/sec; V - 335 ml.

Claims (1)

A method for robot-assisted laparoscopic colposuspension for stress urinary incontinence in women, comprising installing laparoscopic trocars, entering the space of Retzius, dividing the cellular spaces, colpopexy, closing the space of Retzius, characterized in that a da Vinci Xi robotic complex is used, trocars are installed as shown in Fig. 1, an optical trocar - R0 in the periumbilical region, the first robotic 8 mm trocar - scissors R1 - along the right midclavicular line, the second robotic 8 mm trocar - bipolar ligating clamp R2 is installed along the left midclavicular line, the third robotic 8 mm trocar - grasper clamp R3 - on the left 5 cm medial to the anterior superior spina iliaca, the assistant 12 mm trocar As1 is installed on the right 5 cm above the anterior superior spina iliaca; using R1 scissors, the vagina is dissected longitudinally 2 cm below the urethra at a distance of 5–6 cm, then the vagina is separated at the level of the posterior pubourethral ligament, a perforation opening into the space of Retzius is formed in the area of the pubourethral ligament, then using the R2 bipolar ligating clamp and the R3 grasper clamp, the ends of the combined sling prosthesis consisting of a 300×11 mm polypropylene mesh, which is cut in the middle, the Alloplant allograft, which has a size of 100×11 mm, is sutured to the mesh in the middle, while the anastomosis zone of the polypropylene mesh and the Alloplant allograft is 20 mm on each side, and the total length of the prosthesis is 360 mm, while the tension of the prosthesis is adjusted until pressure is achieved on the urethra when holding urine at cough test; inserted through a perforation into the Retzius space on both sides, the sling prosthesis is pulled by the ends into the Retzius space and placed under the urethra, using R1, whose scissors are first replaced with a needle holder, the prosthesis is fixed to the Arcus tendineus musculi levatoris ani, then the ends of the prosthesis are fixed to Cooper's ligament on both sides.