RU2141793C1 - Method for treating the cases of urinary stress incontinence in women - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves cutting out vaginal flap and producing a tube from the flap. the tube is fixed around the urinary bladder neck. The flap is sutured with long ligatures along the edges. The ligatures are conduced into suprapubic region by means of perineal perforator. The ligatures are fixed with delay. The ligatures are fixed in prestressed state for 2-4 days. Combined urodynamic examination is carried out as the postoperative edema vanishing. The urodynamic properties achieving norm, the ligatures are completely tightened. Loss of urine being detected in accomplishing test, ligature tension is released until urination comes to norm. EFFECT: individual approach in restoring normal anatomic conditions and urinary bladder function.

Description

 The invention relates to medicine and will find application in the treatment of urinary incontinence in women.

 Stress urinary incontinence is one of the most common diseases that are difficult to treat. This disease occurs at any age and does not depend on living conditions and the nature of work, however, it is most often observed in women aged 40 to 50 years.

 According to domestic and foreign literature, about 15-20% of women with pathology of the genitourinary organs suffer from this disease. Many authors report a large number of clinical observations. So, B.V. Eremin (1985) in his PhD thesis “Conservative methods of treating urinary incontinence in women” indicates a rather large number of cases of urinary incontinence in 19.5% of 2255 women examined in connection with urination disorders. According to the results of the survey by D. Yu. Pushkar, 1995, published in the Collection of scientific works of the Moscow Medical Dental Institute named after N. A. Semashko "Reconstructive plastic surgery", involuntary urination during physical exertion occurs in 25% of women. E.S. Rovner et al. (1997) consider that the incidence of urinary incontinence ranges from 15 to 35%, data from the journal World-J-Urol, 15 (5), 1997.

 First of all, urinary incontinence is a symptom that occurs as a result of damage to the muscular, nervous and connective tissues of the pelvic floor. The most important factors in the biomechanism of urine retention are: the supporting apparatus of the urethra, adequate function of the neck of the bladder and urethral muscles.

 The main direction of treatment of this pathology is surgical intervention.

 The international literature has covered more than 1,500 methods and modifications of the surgical treatment of stress urinary incontinence. However, most of them are ineffective, as relapses of incontinence often occur, requiring repeated, complex and unsafe interventions, and frequent, imperative urges to urinate appear.

 Currently, for the correction of primary forms of urinary incontinence, the most common are various options for percutaneous urethrocervicopexy combined combined tubo-vaginal access. In Russia, transdermal urethrocervicopexy have been used at the Department of Urogynecology at the Moscow Institute of Medicine named after N.A.Semashko since 1991, their effectiveness according to D.Yu. Pushkar et al. 1995, published in the collection of scientific works of the Moscow Medical Dental Institute named after N. A. Semashko "Reconstructive - plastic surgery" is 84.4%.

 All types of operations performed by combined access are aimed at restoring the normal anatomical position of the urethro-vesical segment. If necessary, simultaneously with these types of operations, plastic operations can be performed with the omission of gynecological organs.

 Various types of pubo-vaginal operations using synthetic and allogeneic materials were also widely used. These operations are called "sling" or loop plastic.

 In the patent literature there are a large number of security documents that protect various methods and devices that can improve the surgical treatment of patients with stress urinary incontinence.

 So, by copyright certificate N 1435244 IPC A 61 B 17/00, Bulletin of the invention N 41, 1988, the "Method for the treatment of urinary incontinence in women with stress" is protected, which provides for cutting two aponeurotic flaps of a trapezoidal shape and strengthening the urethra with them, all its extent.

 Copyright certificate N 1437003, IPC A 61 B 17/00, Bulletin of the invention N 42, 1988, is protected by the "Method of autodermal plasty when lowering the anterior wall of the vagina", which includes surgical intervention, cutting from the pubic area and the upper third of the labia majora autodermal flap and its fixation to the posterior surface of the pubic bones, to the anterior wall of the uterus and vesicovaginal fascia.

 Copyright certificate N 1597178 IPC A 61 B 17/00, Bulletin of the invention N 37, 1990, protected "Method for the treatment of urinary incontinence in total female hypospadias" by surgery, the formation of the distal urethra from the front wall of the vagina, suturing the back wall of the bladder after mobilization of the bladder triangle.

 Copyright certificate N 1621884 IPC A 61 B 17/00, Bulletin of the invention N 3, 1991, protected "Method for the treatment of prolapse of the anterior wall of the vagina complicated by urinary incontinence", involving surgical intervention, the application of transverse narrowing the lumen of the urethra sutures on the paraurethral tissue and the anterior urethral wall.

 Patent certificate N 1639639 IPC A 61B 17/00, Bulletin of the invention N 13, 1991, protected "Method for the surgical treatment of neurogenic bladder dysfunction", characterized in that in order to restore urination, stitch the most extraperitonized bladder and large omentum with subsequent movement of the bladder intraperitoneally, by suturing the parietal peritoneum to the neck of the bladder.

 These operations constantly fix the urethra in the place where the pressure transfer is adequate and urine loss does not occur. However, many of the patients after the intervention lose their ability to urinate voluntarily or have difficulty emptying the bladder; in many of them, urination occurs with increased abdominal pressure (with straining).

 When studying the results of percutaneous post-papillon urethrocervicopexy, pubo-vaginal sling operations, S. Raz (1996) found that 85% of patients after the operation show signs of urethral obstruction, which 5% of them require periodic catheterization of the bladder. Carr L.K .; Webster GD, J Urol (3) 1997, showed that in 5-7% of patients after urethrocervicopexy and in 4-10% after tubo-vaginal sling operations, in the immediate postoperative period there is urethral obstruction requiring repeated surgery - urethrolysis . In addition, another reason for impaired bladder emptying after these interventions is imperative urgency and resistance to therapy, imperative urinary incontinence, which are found in 8–25% of cases more often than urinary retention.

 N. Bhatia (1995), in a comparative analysis of sling operations using autotissues and artificial synthetic material, showed that a flap of synthetic materials more often leads to urethral obstruction and detrusor instability.

 According to H. Bhatia (1995), S. Raz (1995), P. Hilton et al. (1998), the causes of urination disorders after surgery in women with urinary incontinence are: iatrogenic urethral obstruction and bladder instability associated with the fact that the degree of tension of the pubo-vaginal fixing ligatures is determined empirically - visually during cystoscopy during surgery, by the degree of "closure" of the bladder neck. In addition, a sufficiently high fixation of the neck of the bladder and urethra can lead to relapse and a change in the type of urinary incontinence, which is also associated with the lack of objective control over the tension of the fixing ligatures.

 Despite the abundance of methods for treating urinary incontinence, their common drawback is low efficiency and the occurrence of new problems during urination, such as urinary retention or imperative incontinence. After treatment, many patients continue to suffer from this disease, leading to an uncomfortable state, psychological and social maladaptation.

 In the patent literature, no methods have been revealed that during the operation strictly individually restore the normal physiology of urination in patients with stress urinary incontinence, as well as eliminate a number of negative consequences that often arise in the postoperative period: chronic urinary retention, lack of spontaneous urination, imperative urinary incontinence.

 The closest in technical essence is the "Method for the surgical treatment of urinary incontinence" a positive decision on the grant of patent of the Russian Federation N 95117714/14 (030910) and 95117715/14 (030911) of October 19, 1995, which is taken as a prototype of percutaneous percutaneous fixations of the proximal urethra and the bladder neck and consists in the formation of a small flap from the skin of the anterior abdominal wall and then holding it around the bladder neck on ligatures from Prolen using a Raz or Pereyra needle. The disadvantage of this method is the lack of objective control of the degree of tension of the pubo-vaginal ligatures.

 The aim of the present invention is an individual approach to the restoration of normal anatomy and adequate function of the bladder and its sphincter apparatus when performing post-step operations to correct stress urinary incontinence, improving the results of surgical treatment of stress urinary incontinence in women, eliminating postoperative urination disorders, preventing delay and imperative incontinence urine.

 Women suffering from urinary incontinence undergo a percutaneous pubo-vaginal urethrocervicopexy with a vaginal flap. The patient under general anesthesia in the position for gynecological operations is used to infiltrate the anterior vaginal wall with a 0.25% novocaine solution in order to facilitate separation of the anterior vaginal wall from the posterior wall of the bladder and bladder-urethral segment. A Foley urethral balloon catheter is inserted into the bladder, 10 ml of physiological saline is injected into the balloon to best visualize the bladder neck. A U-shaped incision is made on the front wall of the vagina and a flap is formed, the base of which falls on the neck of the bladder, then the front wall of the vagina is separated from the back wall and the neck of the bladder. The formed flap is folded into a tube, fixed in the neck of the bladder and stitched along the edges with long ligatures from Proline. Mobilization of the behind-the-casing space is performed. If necessary, cystocele is performed using pubo-cervical ligaments and smooth muscle elements of the posterior wall of the bladder. Then, in the suprapubic region, 2 punctures of the skin, subcutaneous tissue, and aponeurosis of the rectus abdominis are performed symmetrically with a perineal needle-puncher, which, through the posterior space, under the control of the index finger, is removed into the vaginal wound. Using this needle, ligatures from Prolen fixed to the edges of the flap are carried out into the suprapubic region, which are fixed to each other under the skin above the aponeurosis, forming a loop. The vaginal wound is sutured with separate catgut sutures. In order to exclude damage to the bladder, cystoscopy is performed.

 In contrast to the described method of urethrocervicopexy, we tie the tubo-vaginal ligatures not during, but 3-4 days after the operation to remove the urethral catheter. This ensures that ligatures from Prolene, fixed to the edges of the flap during the vaginal stage and removed using a perineal needle-puncher on the skin of the suprapubic region, are temporarily fixed using the “Device used in the surgical treatment of stress urinary incontinence in women,” an application for Utility model N 99102452. The tubo-vaginal ligatures with this device are pulled to the required level, ensuring an adequate anatomical position of the bladder neck, and fixed at this level. The sterility of the fixing ligatures is provided by the protective cover of the device. The operation is completed by the installation of a Foley urethral balloon catheter and vaginal plugging.

Within 3-4 days of the postoperative period, when edema in the neck of the bladder and periurethral tissues usually disappears, patients undergo an urodynamic study: uroflowmetry, at which the maximum urination rate (Q _max ), retrograde mycotic cystourethromanometry with rectomemetry and anal electromyography are recorded sphincter at which point the pressure in the bladder at rest and during the filling while simultaneously record bladder pressure at maximum flow (PQ _max) and bryush oh cavity (P _abd) and stress uretroprofilometriyu at which the evaluated factor transmission abdominal pressure fluctuations in the region of the bladder and vesicourethral segment (TF%), as well as determine the threshold of abdominal pressure at which loss of urine in the horizontal and vertical position patient (VLPP). If these indicators indicate normalization of the function of urination, final fixation of the tubo-vaginal ligatures is performed, and it is strictly individual, provided that the adequate transmission of increased abdominal pressure to the bladder, vesicourethral segment and urethra (TF - 35-49%) is restored, without loss urine during provocative tests, the Valsava test in the horizontal and vertical position of the patient, as well as subject to the restoration of the physiological (nonobstructive) nature of urination, in which m bladder pressure at the flow adjustment does not exceed 45 cm H ₂ O, and the intra-abdominal pressure is not increased more than 25 cm H ₂ O.

 Thus, tying of the pubo-vaginal ligatures in the delayed postoperative period with urodynamic control allows us to verify the effectiveness of treatment and achieve the optimal anatomical position of the urethra, in which the transmission of abdominal pressure fluctuations is carried out, and normal physiological urination in the postoperative period is restored strictly individually for each patient . This will improve the results of surgical treatment in patients with stress urinary incontinence, and also avoid a number of negative consequences that often occur in the postoperative period: chronic urinary retention, lack of spontaneous urination, and urinary incontinence.

The following example illustrates the proposed method:
Patient P., 49 years old, medical history N 400180, applied for an advisory appointment at the Health Center 1. 06.98, with complaints of urine loss during cough, minimal physical exertion, movement. The patient has observed symptoms of stress urinary incontinence for more than 8 years, however, over the past 2 years, the disease progressed, urine loss began to be noted with minimal physical exertion and with movement.

 When a vaginal examination, the prolapse of the walls of the vagina 2 tbsp, cystocele 2 tbsp., Moderately expressed rectocele. During the cough test and the Valsava test, urine loss is visually recorded.

Survey conducted: Determination of the anatomical and topographic position of the urethro-vesical segment and changes in the urethro-vesical angle and the angle of inclination of the urethral axis to the vertical were determined on the basis of an X-ray examination according to the classification of Green (1986) (cystograms in front and side projection with visualization of the urethra at rest and at tension in horizontal and vertical position), at which a pronounced displacement of the urethro-vesical segment in the vertical position was revealed, in relation to the pubic symphysis by 2 cm, smoothing of the posterior cystic-urethral angle up to 170 ^o , a central defect of the pubo-cervical ligament in the form of cystoureterocele 2 tbsp. was detected, type II disturbances in the position of the urethro-vesical segment were diagnosed.

According to uroflowmetry, a non-obstructive type of urination was determined - the maximum urination rate (Q _max ) was 24 ml / s, according to a combined urodynamic study, detrusor normoreflexion was observed with a moderate decrease in its contractility, without signs of instability. When conducting stress urethroprofilometry, a marked decrease in the transmission factor of increased abdominal pressure to the bladder and urethro-vesical segment (TF%) to 0.4 - 0.7% was noted, and urine losses of 5-8 ml were recorded. The test for determining the abdominal pressure threshold was positive - urine loss occurred with a minimum increase in intra-abdominal pressure to 59 cm H ₂ O.

 According to transabdominal ultrasound examination of concomitant pathology from the side of gynecological organs was not determined, residual urine of 50 ml.

 When cystoscopy revealed moderate inflammatory changes in the neck of the bladder, indirect signs of vesicoptosis. In laboratory tests of urine and blood, pathology was not detected.

 Based on the examination, the patient was diagnosed with an anatomical form of type 2 stress urinary incontinence according to McGuire classification (1989), in combination with gynecological prolapse of the vaginal walls with cystoureterocele 2 tbsp., Rectocele 1 tbsp.

 06/11/98, the patient underwent an operation - percutaneous post-phylactic urethrocervicopexy with a vaginal flap and cystocele removal, with delayed tying of fixative ligatures in the immediate postoperative period using the "Device used in the surgical treatment of stress urinary incontinence in women", application No. 991052.

The postoperative period was uneventful. On the 4th day after the disappearance of edema in the neck of the bladder and periurethral tissues, the patient had an urethral balloon catheter. Under the control of an urodynamic study, the degree of tension of the pubo-vaginal ligatures was individually selected, which allows to create the optimal anatomical position of the urethra and bladder, in which an adequate transmission of fluctuations in intra-abdominal pressure was carried out, and normal physiological urination was restored. The following urodynamic parameters were taken as the basis: the maximum urination rate is 19 ml / s, the detrusor pressure at the height of the urine flow P (Q _max ) 36 cm H ₂ O, the maximum detrusor pressure (P _max ) is within 41 cm H ₂ O ; abdominal pressure (P _abd ) during the mixing - 28 cm H ₂ O. The main criterion for the adequacy of the tension of the threads was a significant increase in the transmission factor compared with preoperative by 35.6% and the absence of urine loss during the test at the threshold of abdominal pressure (VLPP) , regardless of body position.

After the degree of tension of the pubo-vaginal ligatures testified to the normalization of the function of urination, the ligatures were completely tied, the device was removed, the skin and fixing threads were treated with 96 ^o alcohol, then local infiltration anesthesia of the site of immersion of the node was performed. The tubo-vaginal filaments were finally tied over the aponeurosis of the rectus abdominis muscles, with an adjustable level of tension and sank under the skin.

 The postoperative period was uneventful, without complications, the patient was discharged from the hospital on the 5th day after the operation. Ultrasound monitoring of residual urine was not determined.

 Examined 1, 3, 6 months after surgery. No complaints, pleased with the result of the operation. Urination is free, without tension, not frequent, does not note the imperative urge to urinate incontinence with stress. A control x-ray and ultrasound examination showed no signs of displacement of the urethro-vesical segment and cystoureterocele. When cystoscopy - deformation and swelling in the neck and bottom of the bladder was not found. During the control urodynamic study, there were no signs of detrusor instability and urethral obstruction, the maximum urination rate was 20 ml / s.

 Recovery occurred as a result of surgical correction of urinary incontinence and individual selection of the degree of tension of the threads in an urodynamic study.

 The proposed method provides an individual approach to the treatment of this pathology, increases the effectiveness of treatment results, and also allows you to restore normal physiological urination.

Claims (1)

 A method for the surgical treatment of women suffering from stress urinary incontinence, which involves surgical intervention, cutting out a vaginal flap, forming a tube from it, fixing it around the neck of the bladder, flashing the flap along the edges with long proline ligatures and carrying them to the supral region using a perineal perforator needle , characterized in that the fixation of the tubovaginal ligatures is carried out not during the operation, but delayed, for which purpose in the supral region at the exit point of the ligatures impose an external device through which the base is inserted into the tubovaginal filaments, then these filaments are temporarily fixed in tensioned position for 2 to 4 days, after the disappearance of postoperative edema, the catheter is removed and combined urodynamic examination is performed - retrograde mycystomy cystomanometry with rectomanometry and anal sphincter electromyography , stress urethroprofilometry with determination of the abdominal pressure threshold, when the urodynamic indicators are normal and restored In order to urinate, the device is removed from the anterior abdominal wall and the tubovaginal ligatures are completely tied, if urine losses are noted during the test at the abdominal pressure threshold, then the degree of tension of the ligatures is increased until urine losses during this test occur and final fixation is performed at this level, if urethral obstruction is observed, then the ligature tension is relaxed until urination normalizes and their final fixation is performed at this level.