RU2799143C2 - Method of forming autosphincter by sero-muscular flap of urinary bladder wall in urinary incontience - Google Patents

Abstract

FIELD: medicine; operative urogynecology.

SUBSTANCE: lower median incision is made, retroperitoneal mobilization of the anterior and lateral walls of the bladder, bladder neck and posterior urethra. The proposed muscle flap is marked from the top of the bladder to its neck, 10 cm long and 4 cm wide at the base of the flap in the bladder neck area, including the blood vessels feeding the flap and the nerves accompanying them. The serous-muscular flap is separated from the mucous membrane in accordance with the marking without opening the lumen of the bladder; a separated serous-muscular flap with the base at the bladder neck containing blood vessels and nerves is moved distally to the bladder neck and urethra area and such an area is fixed with interrupted sutures with absorbable atraumatic polymer sutures. The area of the seromuscular defect of the bladder wall is sutured with a continuous suture using atraumatic absorbable sutures.

EFFECT: method allows to use own tissues of the muscular membrane of the bladder and preserve the original sources of blood supply and innervation of the flap used to form the sphincter; change the tone of the sphincter depending on the degree of filling of the bladder; eliminate the formation of a cosmetic defect.

1 cl, 2 ex, 1 tbl, 7 dwg

Description

The invention relates to the field of medicine, in particular to urology, and is directed to the formation of the sphincter of the bladder from its own tissues.

The problem of urinary incontinence in men and women of advanced age is very relevant. In men, the main cause of urinary incontinence is the need for prostate surgery due to the development of benign prostatic hyperplasia or prostate cancer, in which the incidence of this complication reaches 49% (Steineck G, Helgesen F, Adolfsson J, et al. Quality of life after radical prostatectomy or watchful waiting N Engl J Med 2002;347:790–6). In women, urinary incontinence develops mainly due to the weakening of the ligamentous organs of the small pelvis and prolapse of the pelvic organs, the frequency of which in various cases reaches 36% of the female population over 55 years old in Russia (Kasyan G.R., Stroganov R.V., Pushkar D. I. Recurrent Urinary Incontinence in Women: Frequency and Treatment Urology 2016 Apr;(2 Suppl 2):76-81 PMID: 28247648).

Thus, the problem of treating urinary incontinence in men and women is very relevant.

Accordingly, various treatment options for this pathological condition have been developed. For the treatment of moderate urinary incontinence in women, special methods of training the pelvic floor muscles have been developed to increase the tone of the external urethral sphincter (Lawson S, Sacks A. Pelvic Floor Physical Therapy and Women's Health Promotion. J Midwifery Womens Health. 2018 Jul;63(4) :410-417 doi: 10.1111/jmwh.12736). However, their effectiveness is very limited. With more pronounced functional disorders, a method has been developed to artificially narrow the lumen of the urethra by pulling it ventrally with an implanted tape (the so-called sling operations), which is used in both men and women. The disadvantages of this approach are the need to introduce a foreign thesis (synthetic tissue strips), leading to the frequent development of reactive inflammation, including suppuration of the surgical site, the development of a persistent pain syndrome, leading in some patients to the removal of the implant, as well as to an unstable functional result, which can manifest itself both in the preservation of urinary incontinence (with insufficient tension of the sling), and in the development of urinary obstruction (with excessive tension). Adjustable sling tension options do not always solve these problems. As a result, the effectiveness of this method progressively decreases with time elapsed after the operation, and is only 24% 5 years after the operation (Brubaker L, Richter HE, Barber MD, Hsu Y, Rahn DD, Menefee S, Visco A, Spino C, Martin S, Meikle SF Pelvic floor disorders clinical trials: participant recruitment and retention Int Urogynecol J 2013 Jan;24(1):73-9 doi: 10.1007/s00192-012-1824-x.

With an extreme degree of functional disorders in men, when previous treatment options are ineffective, mechanical artificial bladder sphincters are used. However, these operations are traumatic, associated with the implantation of foreign bodies of a sufficiently large volume both in the abdominal wall and the scrotum, which determines the high risk of complications that require revision of the implants in 34% of cases, and their removal in 27% (Radomski SB , Ruzhynsky V, Wallis CJD, Herschorn S. Complications and Interventions in Patients with an Artificial Urinary Sphincter: Long-Term Results J Urol 2018 Nov;200(5):1093-1098 doi: 10.1016/j.juro.2018.05 .143). There is also a high risk of developing overactive bladder (up to 37.5%) in response to the introduction of a foreign body (Ko KJ, Lee CU, Kim TH, Suh YS, Lee KS. Predictive Factors of De Novo Overactive Bladder After Artificial Urinary Sphincter Implantation in Men With Postprostatectomy Incontinence Urology 2018 Mar;113:215-219 doi: 10.1016/j.urology.2017.09.027). In addition, older men may have difficulty regulating the work of the sphincter due to age-related mental changes. An important factor is that all artificial bladder sphincters are imported and in modern conditions their availability can be severely limited.

An alternative treatment for urinary incontinence in both men and women is the formation of the bladder sphincter using the body's own tissues, which reduces the likelihood of inflammatory complications and allows you to count on a long-term therapeutic effect.

A known method of surgical treatment of urinary incontinence in women (RU 2721140 C1). Perform endoscopic access to the prevesical space. Trocars are installed in the right iliac region, under conditions of carboxyextraperitoneum, the side walls of the vagina are isolated. Double ligatures are applied to the anterior-lateral wall of the vagina in the region of the bladder neck on both sides of the urethra and fixed to the lacunar ligaments. The method allows to effectively eliminate urinary incontinence and reduce the duration of postoperative rehabilitation.

However, this method is applicable only to women. At the same time, it provides only an increase in mechanical resistance to the flow of urine through the urethra due to its additional bending and does not improve the functioning of the sphincter, and therefore, sufficient functionality of urination. In addition, the use of suture fixation of tissues may not provide stable long-term results due to the possible stretching of tissues, especially in elderly patients.

A known method for the treatment of recurrent forms of urinary incontinence in women (RU 2623488 C1). A retropubic loop urethropexy is performed with a tape for sling operations. Tapes are placed on the aponeurosis of the anterior abdominal wall towards each other. The excess tape is cut at the level of the skin and left in a free state in the subcutaneous tissue of the suprapubic region. In the event of a relapse, the ends of the tape are isolated and brought into and out into opposite skin incisions. Expand the holes in the aponeurosis until the mobility of the tape. Re-tension and fix the tape. EFFECT: method makes it possible to exclude repeated, in full, performance of the operation for implantation of a new tape for sling operations in case of recurrence of urinary incontinence, reduces the risk of intra- and postoperative complications, the risk of perforation and erosion of the urethra.

However, this method is only a variation of sling operations and has the same disadvantages as mentioned above.

A method has been proposed for using the fascia of the rectus abdominis muscle with the formation of a loop around the urethra in order to narrow its lumen (Nadir I Osman, Christopher J Hillary, Altaf Mangera, Reem Aldamanhoori, Richard D Inman, Christopher R Chapple. The Midurethral Fascial "Sling on a String": An Alternative to Midurethral Synthetic Tapes in the Era of Mesh Complications Eur Urol 2018 Aug;74(2):191-196 doi: 10.1016/j.eururo.2018.04.031). The disadvantages of this method is the difficulty of regulating the degree of tension of the fascial tape and the degree of narrowing of the urethra, which can lead to both the preservation of urinary incontinence and the difficulty of its removal (obstructive syndrome). The proportion of these complications is especially high in patients with previous surgeries on the organs of the urinary system, reaching 10.5-14%. In addition, this operation is very traumatic and leads to a significant cosmetic defect.

A known method for the treatment of urinary incontinence in women (RU 2772634 C1). The flap is inserted into the soft tissue through the vagina. In this case, the treatment is carried out at a pressure in the urethra of 20-50 cm of water. Art. and consistency of the fourth micturition reflex according to Mahoney based on the results of dynamic profilometry. The flap is implanted in the space between the anterior wall of the vagina and the urethra in the area of its proximal part, fixing to the neck of the bladder with separate sutures.

However, this method is feasible only in women and is not applicable to men with urinary incontinence.

Closest to the claimed method is a method of forming an artificial urethral sphincter by moving m.gracilis and wrapping the urethra in the form of a ring (Chancellor MB, Hong RD, Rivas DA, Watanabe T, Crewalk JA, Bourgeois I. Gracilis urethromyoplasty - an autologous urinary sphincter for neurologically impaired patients with stress incontinence Spinal Cord 1997 Aug;35(8):546-9 doi: 10.1038/sj.sc.3100444). The contraction of the muscle should carry out the sphincter mechanism and ensure the retention of urine.

However, the known method has the following disadvantages:

- m.gracilis is largely supplied by perforating arteries, which have variable localization, which is associated with the risk of damage and bleeding during muscle isolation, and this can impair its blood supply, which increases the risk of flap necrosis with the development of its sclerosis and/or fistulas;

- invasiveness of the operation, in which it is necessary to perform large incisions on the inner surface of the thigh;

- the moved muscle is striated with a different function than the smooth muscle detrusor sphincter and has a different innervation, which can cause inconsistency in the contraction of the bladder and the tone of the moved m.gracilis.

The proposed method is aimed at eliminating the above disadvantages.

The objective of this invention is the formation of an artificial sphincter of the bladder from a cut serous-muscular flap of the anterior wall of the bladder with the preservation of the feeding leg, which allows to provide the function of urinary retention and be more physiological.

The problem is solved by the fact that, as well as in the known method, a lower-median incision is performed, the anterior and lateral walls of the bladder, the bladder neck and the posterior urethra are mobilized retroperitoneally.

A feature of the proposed method is that the proposed muscle flap is marked from the top of the bladder to its neck measuring 10 cm in length and 4 cm in width at the base of the flap in the region of the bladder neck with the inclusion of large trunks of feeding blood vessels and their accompanying nerves , in accordance with the markup, the serous-muscular flap is separated from the mucous membrane without opening the lumen of the bladder, the separated serous-muscular flap with a base at the bladder neck, containing blood vessels and nerves, is moved distally to the region of the bladder neck and urethra with dense surrounding this section and fixation with interrupted sutures with absorbable atraumatic polymer sutures, the area of the serous-muscular defect of the bladder wall is sutured with a continuous suture using atraumatic absorbable sutures.

The method is illustrated by a detailed description, examples of execution and illustrations, which show:

Fig. 1 - photo illustration of the appearance of the removed bladder, laid in a natural position with the markup of the proposed flap by incision of the serous membrane with a scalpel (indicated by arrows).

Fig. 2 - photo illustration of cutting out a serous-muscular flap from the anterior wall of the bladder.

Fig. 3 - photo illustration of the displacement of the cut flap into the area of the prevesical urethra and its fixation around the urethra.

Fig. 4 - photo illustration of the final formation of the autosphincter and suturing of the defect in the anterior wall of the bladder.

Fig.5 - urethrocystogram of the bladder. rabbit after modeling urinary incontinence. The arrow indicates the absence of narrowing of the urethra in the region of the internal bladder sphincter.

Fig. 6 - photo illustration of the appearance of the surgical field after the formation of an autosphincter from the serous-muscular layer of the rabbit's own bladder:

1 - bladder;

2 - formed autosphincter;

3 - urethra.

Fig. 7 - urethrocystogram of a rabbit 1 month after the formation of an autosphincter from a serous-muscular flap of its own bladder (the arrow indicates the narrowing of the urethra in the region of the formed sphincter).

The method is carried out as follows.

Under general anesthesia, a lower-median incision is made, the anterior and lateral walls of the bladder, the neck of the bladder and the posterior urethra are mobilized retroperitoneally. The proposed muscle flap is marked from the top of the bladder to its neck, 10 cm in length and 4 cm at the base of the flap in the area of the bladder neck, with the obligatory inclusion of large trunks of the supplying blood vessels and their accompanying nerves. In accordance with the markup, the serous-muscular flap is separated from the mucous membrane without opening the lumen of the bladder. A separated serous-muscular flap with a base at the bladder neck, containing blood vessels and nerves, is moved distally to the area of the bladder neck and urethra with a dense environment of this department and fixation with interrupted sutures, absorbable atraumatic polymer sutures. The area of the seromuscular defect is sutured with a continuous suture using atraumatic absorbable sutures.

The effectiveness of the proposed method is illustrated by the following examples.

Example 1 - surgical substantiation of the possibility of forming an autosphincter from a serous-muscular flap of one's own bladder without opening its lumen.

Patient H., 62 years old, was admitted with a diagnosis of bladder cancer T3N0M0. The patient underwent a radical cystectomy. On the removed bladder, an imitation of an operation to form an autosphincter of the bladder was performed.

The removed bladder was placed in a position corresponding to its natural location in the body, and a proposed flap measuring 10 cm in length and 4 cm in width was marked by incising the serous membrane of the organ with a scalpel (Fig. 1). After marking, the serous-muscular flap was separated from the apex to the base of the bladder, while maintaining the feeding pedicle at the base in the area close to the neck of the bladder without damaging the mucous membrane and opening the lumen of the bladder (Fig. 2). The separated flap was moved distally and wrapped around the prevesical urethra in the area of the internal sphincter of the bladder and fixed there with atraumatic suture material (Fig. 3). At the same time, a ring-shaped structure was formed containing the muscles of the bladder, covering the urethra and capable of forming a holding mechanism, preventing urinary incontinence. The defect of the seromuscular membrane was sutured, restoring a full wall of the bladder (Fig. 4).

This example illustrates the technical possibility of forming an autosphincter of the bladder due to its own tissues (serous-muscular flap) without opening the lumen of the bladder. The method provides a good functional effect (urine retention) while minimizing the risk of surgical complications.

Example 2 - proof of the functional efficiency of an autosphincter formed from a serous-muscular flap of one's own bladder.

Modeling of urinary incontinence was performed in 3 rabbits under general anesthesia by balloon dilatation of the bladder neck and prevesical urethra. Overstretching of the sphincter caused its long-term dysfunction. 3 days after the simulation, a urethrogram was performed to confirm the dysfunction of the sphincter and to detect the absence of narrowing of the urethra in the region of the internal sphincter (Fig. 5).

Under general anesthesia, the bladder was isolated, punctured with a G18 intravenous catheter to perform filling cystometry. The bladder was emptied and gradually filled with warm saline. solution with the determination of the maximum functional volume of the bladder and intravesical pressure. After taking the indicators, the autosphincter of the bladder was formed according to the claimed method with cutting out the serous-muscular flap of the muscular membrane of the bladder without opening its lumen and moving it to the region of the bladder neck and prevesical urethra (Fig. 6). After 2 weeks, the animals were re-examined with urethrography and filling cystometry.

The results of the examination showed that the urethrogram revealed a narrowing of the urethra in the area of the formed autosphincter (Fig. 7). Filling cystometry revealed a significant increase in the functional volume of the bladder, as well as the level of intravesical pressure at which urination began, which indicated an increase in the ability of the bladder to accumulate urine and retain it (see table).

From the data of the table it can be seen that in all 3 rabbits after the formation of an autosphincter according to the claimed method, an increase in the capacity of the bladder before the start of urination (by 9-10 ml), as well as an increase in intravesical pressure, at which urination began (by 8-12 cm of aq. Art.), which indicates that the formed autosphincter increases the efficiency of urinary retention in case of dysfunction of the natural sphincter of the bladder.

The proposed method allows:

- use your own tissues of the muscular membrane of the bladder (the muscular membrane of which consists of smooth muscle cells, that is, the same cells as in your own internal sphincter of the bladder, while in the prototype method, skeletal muscle with striated muscle fibers is used);

- preserve the original sources of blood supply and innervation of the flap used to form the sphincter (both autonomic nerve fibers, both sympathetic and parasympathetic, are preserved, as well as sensory innervation emanating from the same parts of the central nervous system as in the norm, while in the method -prototype flap is innervated only by motor fibers extending from motor neurons of other departments);

- change the tone of the sphincter depending on the degree of filling of the bladder;

- exclude the formation of a cosmetic defect.

Claims (1)

A method for forming an autosphincter with a serous-muscular flap of the bladder wall during urinary incontinence, including a lower-median incision, retroperitoneal mobilization of the anterior and lateral walls of the bladder, bladder neck and posterior urethra, characterized in that the proposed muscle flap is marked from the top of the bladder to its neck measuring 10 cm in length and 4 cm in width at the base of the flap in the region of the bladder neck with the inclusion of the blood vessels feeding the flap and the nerves accompanying them, in accordance with the markup, the serous-muscular flap is separated from the mucous membrane without opening the lumen of the bladder, a separated serous-muscular flap with a base at the bladder neck, containing blood vessels and nerves, is moved distally to the region of the bladder neck and urethra with the surrounding of this section and fixation with interrupted sutures with absorbable atraumatic polymer threads, the area of the serous-muscular defect of the bladder wall The bladder is sutured with a continuous suture using atraumatic absorbable sutures.

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