RU2567329C1 - Method for surgical management of stress-induced urinary incontinence in females of reproductive age with use of collost collagen material - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: treating stress-induced urinary incontinence in females involves using Collost biomaterial implant. Paraurethral canals are formed. The implant is immersed into a middle portion of the urethra. Implant edges are anchored to urethral muscles and vaginovesical fascia.

EFFECT: method enables eliminating sphincteric failure of urinary bladder by narrowing a proximal portion of the urethra and reinforcing the vaginovesical plate.

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Description

The present invention relates to medicine, namely to obstetrics and gynecology, and can be used for surgical treatment of stress urinary incontinence in women.

Most often, stress urinary incontinence (CHM) manifests itself after childbirth through the natural birth canal and trauma during delivery operations. This condition should be considered as a violation of the integrity of the sphincter due to pressure on the walls of the birth canal by the fetal head, which leads to compression and ischemia of the urethral sphincter. When analyzing the history of childbirth of the women we operated on for urinary incontinence, it was possible to find out that urinary incontinence is more often observed with repeated births in head presentation.

Stress incontinence does not always appear immediately in the early or late postpartum period, but is often recognized after a long period of time after damage to the sphincter. The formation of urinary incontinence after cesarean section was observed in only one case.

The use of obstetric operations in the absence of appropriate conditions, as well as untimely assistance in most cases, is responsible for the occurrence of urinary incontinence. Thus, based on the data of several authors, as well as our observations, it can be concluded that delivery surgery is a secondary factor in the development of urinary incontinence. However, if a patient with signs of stressful incontinence has a normal pelvis, the child weighed no more than 3,500 kg, the birth was not prolonged and obstetric surgery was used, then incontinence can be attributed to surgical intervention.

One of the main causes of SNM is tissue trauma during childbirth through the natural birth canal in the head presentation, which depends on a number of factors: density of the bones of the skull, condition of the tissues before childbirth, the presence of scar tissue and repeated trauma to the birth canal.

Currently, the “gold” standard in the surgical treatment of women for stress urinary incontinence is TVT (Tension-free Vaginal Tare) surgery. The original method of surgical treatment was developed by Professor U. Ulmsten in 1995 at the University Hospital Uppsala (Sweden). In this operation, a synthetic loop (tape) from the vagina is carried out into the suprapubic region and left in the tissues without additional fixation. Thus, the synthetic midurethral loop replaces the damaged fascial apparatus of the urogenital diaphragm. In this case, fixation of the urethra is achieved, and conditions are created for transferring the force of the deep transverse muscle of the perineum to the urethra [Navneet Magon. Stress urinary incontinence: What, when, why, and then what? / Navneet Magon, Bharti Kalra, Sonia Malik, Monica Chauhan // J. Midlife Health. - 2011 .-- vol. 2. No. 2 P. 57-64]. In 2001, V. Delmas in France introduced a transobturator access procedure with an antegrade loop option. In 2003, at the University of Liege (Belgium), J. De Laval proposed a surgical method for the correction of urinary incontinence in women using the Transobturator vaginal tape (TVT-O) technique [Patrick Richard. “U-Method” TVT-Secur Slings: Are they obstructive Can / Patrick Richard, Louis-Olivier Gagnon, Le Mai Tu // Urol Assoc J. - 2012, vol. 6 - No. 2. P. 48-51].

Further development of minimally invasive technologies in the treatment of heart failure was associated with the desire to prevent and minimize the complications of this type of intervention.

In recent years, “mini-sings” have appeared to treat stress urinary incontinence. The technology of their installation does not involve the removal of the tape on the skin and contact with the wall of the bladder, which minimized the procedure. The founder of the development of “minisling” is the company Gynecare (Ethicon), which released in 2006 the TVT-Secur * (TVT-S *) system. With the help of special tools (insectors), the tape can be installed in two positions: U-shaped (its ends are fixed in the post-pulp fiber) and the метод-method (the ends are fixed in the fiber of the obstructive fossae, not reaching the internal obturator muscle). The main goal is to enter the midurethral loop through a single incision, minimally injuring the vessels and nerves. It should be noted that a small amount of synthetic material is used, which reduces the risk of complications in the postoperative period [Patrick Richard. “U-Method” TVT-Secur Slings: Are they obstructive Can / Patrick Richard, Louis-Olivier Gagnon, Le Mai Tu // Urol Assoc J. - 2012, vol. 6 - No. 2. P. 48-51].

The third-generation tape used for minimally invasive incontinence correction surgery was developed by MiniArc ™ at 2007 American Medical Systems. The MiniArc ™ sling system is installed through a single incision, while minimizing tissue damage, reducing the number of incisions from three to one [Michael J Kennelly. Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. / Michael J Kennelly, Robert Moore, John N. Nguyen, James Lukban, Steven Siegel // International Urogynecology Journal - 2012, vol. 23, No. 9. P.- 1285-1291].

Urosling is a domestic endoprosthesis designed to perform operations on the installation of a synthetic suburethral sling. This method has several advantages over others: it is resistant to stretching (due to the smaller diameter of monofilaments), it is atraumatic (there are no sharp edges), bioinertness and flexibility are increased, and at the same time resistance to infections remains [Petrov SB Urosling in the post-cilium and transobturator positions: three years of experience in minimally invasive surgical treatment of stress urinary incontinence in women / S.B. Petrov, A.V. Kurenkov, D.D. Shkarupa / Journal of Obstetrics and Women's Diseases // 2009 - T.58, No. 1. S.33-37].

Given the current trend of improving methods for surgical correction of SNM, periurethral administration of volume-forming substances is becoming more relevant. In the literature there are data on various volume-forming substances. Indications for use are: severe somatic status, relapse after anti-stress operations, stress urinary incontinence.

Surgical gynecology has many surgical methods for treating urinary incontinence, but none of them takes into account the full realization of reproductive potential, since vaginal delivery is one of the main etiological factors for stress urinary incontinence.

The closest analogue of the invention is a method of surgical treatment of SNM in an experiment on rabbits, including implantation of the Kollost biomaterial in the area of the bladder neck during a sling operation. Kollost is a sterile bioplastic collagen material with a completely preserved fibrous structure that provides tissue regeneration. This study showed that Collost leads to an increase in the proliferation of fibroblasts, an increase in secretory activity against collagenase: an ordered arrangement of collagen fibers occurs, and lymphocytes and macrophages are activated that regulate the processes of reparative regeneration. A twofold increase in the synthesis of collagenase by fibroblasts promotes increased collagen destruction at the implantation site, which, in turn, leads to its replacement with new collagen and elastic fibers [O.B. Laurent, L.A. Sinyakova, V.K. Shishlo, A.V. Dementieva. Possibilities of using collagen (Collost) as a material for sling operations for female urinary incontinence [Electronic resource] Access mode: http://www.fesmu.ru/elib/Article.aspx?id=l58440. - Date of access: 05.16.2014].

The use of Kollost showed the safety of its use in connection with the absence of inflammatory changes and rejection reactions. Kollost compares favorably with other drugs based on the following parameters: biomorphological (the intermolecular bond between fibrils is preserved, resistance to proteolytic enzymes, the optimal level of cleaning from ballast substances) and economic (affordable cost), which determines its advantages over known synthetic materials. The possibility of delivery through the natural birth canal after surgical treatment of stress urinary incontinence using the material Kollost.

The objective of the invention is to develop a sling operation using Kollost biomaterial in young women planning a future pregnancy.

The technical result when using the invention is to increase the strength of the wall of the sphincter of the bladder due to the narrowing of the proximal urethra and strengthening the cystic fascial plate.

The invention is illustrated by the following figures: in FIG. 1 shows the formation from a collagen membrane of dimensions 60 * 50 * 1.5 mm of a rectangular implant corresponding to the length of the urethra, with ends in the form of an isosceles trapezoid along the length of the paraurethral canals; in FIG. 2 - the implant is placed in the middle part of the urethra. The free edges of the implant are sutured directly to the urethral muscle with a single-row knotted catgut suture. The free trapezoidal ends of the implant are sutured to the vesicovaginal fascia; in FIG. 3 - the front wall of the vagina is sutured with a continuous vikrilovy seam.

The proposed method for the surgical treatment of SNM is as follows. The patient is in position for gynecological operations. The vagina is exposed using mirrors. A Foley No. 18 catheter is placed in the bladder. The front lip of the cervix is captured by bullet forceps and brought down. On the front elongated wall, a median longitudinal section is made of a length of 3-3.5 cm, starting 1 cm below the external opening of the urethra. The edges of the cut wall of the vagina are captured and parted by Kocher clamps on each side. A median longitudinal section dissects the vesicovaginal fascia. After that, paraurethral channels are formed in an acute and blunt way. A square-shaped implant with a width corresponding to the length of the urethra is cut out of a collagen membrane with dimensions of 60 * 50 * 1.5 mm, the ends of the implant are excised in the form of an isosceles trapezoid along the length of the paraurethral canals. Then the implant is placed in the middle part of the urethra. The edges of the collagen implant are sutured directly to the urethral muscle with a single-row knotted catgut suture, and its trapezoidal ends are sutured to the vesicovaginal fascia. About 300 ml of sterile physiological saline or furatsilina are administered via the Foley catheter. The catheter is removed. If the cough test is positive, additional closure of the fascia is performed with a single-row knotted nylon seam. In case the cough test is negative, the front wall of the vagina is sutured with a continuous vikril seam. Bleeding is usually minor and rarely suture additional. The result is achieved by narrowing the proximal urethra and increasing its length.

It is known that the vesicovaginal fascia after childbirth becomes thinner and its structure is disturbed. In the claimed method, the trapezoidal ends of the membranes, stitched to the fascia, strengthen the vesicle-fascial plate, which ensures the strength of the sphincter wall, leads to a narrowing of the proximal urethra, differentiation of type I collagen occurs on the vaginal mucosa, which subsequently leads to the stability of the pelvic floor to increase intraperitoneal pressure.

Inspection Methods.

An allergic test was performed 14 days before surgery. 0.1 ml of gel was injected intradermally into the forearm using a 27 1 / 2G needle. All patients underwent a comprehensive phased clinical and laboratory examination: Stage 1 - a general clinical examination, including filling in urination diaries; assessment of complaints and obstetric history. Stage 2 - urogynecological examination (cough test, Valsalva test, one-hour cushioning test or 60-minute step test, stop test), systematic assessment of the perineum by POP-Q, uroflowmetry. Stage 3 - ultrasound examination.

In the postoperative period, local treatment, antibacterial, anti-inflammatory therapy was performed. Extract was carried out for 3 days.

This surgical treatment technique is applicable under the following conditions:

1. Women under 40 years of age planning a future pregnancy.

2. Lack of indication for childbirth through the natural birth canal.

3. Established etiological factor, sphincter insufficiency.

4. Unsuccessful conservative therapy.

The invention is illustrated by the following clinical example. Patient X 32 years old turned to the base of the Department of Obstetrics and Gynecology No. 2 with complaints of urinary incontinence during laughter, sexual intercourse and physical activity, without signs of connective tissue dysplasia and without deviations, in general, and bacteriological analysis of urine. A history of two births: the first weighing 3200 kg with a height of 51, the second weighing 3700 with a height of 53 cm. There were no obstetric surgeries in the birth. Patient normosthenic physique, satisfactory nutrition. Operations on the pelvic organs denied. For the first time, signs of urinary incontinence were noted after repeated birth. There is no effect after a conservative course of treatment. The study found the following:

1- POP-Q (Pelvic Organ Prolapse Quantification Stage) 0 - points Aa, Ap, Ba, Bp - all 3 cm; points C and D with a minus sign.

2 - Ultrasound examination was carried out by a two-dimensional vaginal probe

2a - the length of the urethra 1.9 cm

2b - proximal width 1.7

2c - urethrovesical angle of 126 degrees

3 - Functional tests

3a - Test Valsalva, or test with straining and cough tests with a positive response

4 - uroflowmetry

4a - maximum flow rate (Qmax) - 57.0 ml / s

4c - volume (V) - 300 ml

5 - Without deviation in the general and bacteriological analysis of urine.

Sphincter bladder failure associated with childbirth through the natural birth canal has been established.

After surgical treatment with the use of Kollost, the study after 6 months revealed:

1 - Ultrasound examination was carried out by a two-dimensional vaginal probe

1a - the length of the urethra 2.3 cm

1b - proximal width, closed

1c - urethrovesical angle of 122 degrees

2 - Functional tests

2a - Valsalva test, or strained test and cough test with a negative answer

3 - uroflowmetry

3a - maximum flow rate (Qmax) - 36.5 ml / s

3c - volume (V) - 330 ml.

Claims (1)

A method for surgical treatment of stress urinary incontinence in women, including implantation of the Kollost biomaterial,
characterized in that a rectangular implant with a width corresponding to the length of the urethra is cut out from a collagen membrane of dimensions 60 * 50 * 1.5 mm, the ends of the implant are excised in the form of an isosceles trapezoid along the length of the paraurethral canals, the implant is placed in the middle part of the urethra, and the edges of the implant are hemmed to the muscles of the urethra with a single-row nodal catgut suture, and its ends are sutured to the vesicovaginal fascia.

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