RU2610000C2 - Method of residual urinary incontinence treatment after implantation of artificial urinary sphincter - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: after the implantation of an artificial sphincter, for residual urinary incontinence treatment, a fat graft enriched in the stromal-vascular fraction is inserted in the submucosa of the urethra along the standing rim area the artificial urinary sphincter ferrule. The insertion is provided endoscopically, through a needle to a depth of 2 mm. After injection, a balloon catheter is installed into the urethra for about 24 hours.

EFFECT: method allows to perform adequate treatment of residual incontinence and eliminate the possibility of infection of a preliminary installed artificial urinary sphincter.

Description

The present invention relates to medicine, namely to urology, and can be used to treat residual urinary incontinence after implantation of an artificial bladder sphincter.

Urinary incontinence is one of the most socially “serious” diseases. Most often, male urinary incontinence occurs after surgical treatment, in most cases it is a radical prostatectomy (RPE). The following data are available in the literature on the incidence of urinary incontinence depending on the intervention: posadilon RPE (Heidenreich A., Bellmunt J., Bolla M. et al. 2012) - 5-48%, nerve-sparing RPE (De Ridder D., Rehder P . 2011) - 1.3-3.4%, robotic RPE (Rehder P., Gozzi C. 2007) - 16%, external radiation therapy - 1-16%, brachytherapy (Engel RM, Wade JC - 1969) - 0 -19%. Thus, according to V. Ficarra, who conducted an analysis of all methods of radical prostatectomy in 2012, on average, urinary incontinence occurs in 6-42% of operated patients.

Urinary incontinence in the late postoperative period (more than 3 months after surgery) is one of the most unpleasant complications for both the patient and the family. For total and orthostatic urinary incontinence, implantation of an artificial urethral sphincter is indicated, 87% of patients who underwent sphincter implantation remain satisfied with the results of the operation (reduction in the number of pads used, no need for additional methods to retain urine) Abrams P., Cardozo L., Khoury S., Wein A. - 2013. And 13% of patients require additional correction of urinary incontinence.

Until recently, the main methods of treating patients with resident urinary incontinence after implantation of an artificial sphincter were performing a second operation with implantation of an additional cuff. In connection with the development and implementation of new urotechnologies, great importance has recently been attached to the methods of treating urological diseases using cellular technologies. Meanwhile, the problem of the treatment of urinary incontinence as a whole has still remained unresolved. Each of the existing methods for the treatment of urinary incontinence has certain disadvantages. Which largely determines the relevance of developing new methods for the treatment of residual urinary incontinence after implantation of an artificial bladder sphincter.

As an analogue, the method of correction of resident urinary incontinence by installing an additional cuff is taken (Kabalin J.N. Addition of a second urethral cuff to enhance performance of the artificial urinary sphincter. J Urol. 1996 Oct .; 156 (4): 1302-4).

The method is as follows: the urethra is accessed openly, the urethral bulbous section is secreted, the second cuff is installed according to the standard method, then through the connector system an additional cuff is connected to the newly installed system. Then carry out hemostasis. The wound is sutured in layers.

Disadvantages:

1) the installation of an additional implant is always associated with an additional risk of infection.

2) the implementation of this method requires an additional incision in the perineum, which increases the time spent in the hospital.

The closest analogue is a method for treating stress urinary incontinence by endoscopic administration of an enriched fat micrograph (Yamamoto T. et al. Periurethral injection of autologous adipose-derived regenerative cells for the treatment of male stress urinary incontinence: Report of three initial cases. International Journal of Urology (2012), July (7), p. 652-659). The method is as follows: using an endoscope, an injection needle is brought into the area of the external sphincter of the urethra. 0.5-1 ml of a concentrated solution enriched in a fat micrograph is injected through a needle into the bulbous-membrane part of the urethra to a depth of 5 mm. Then, through the same needle, under the mucous membrane of the urethra in the area of the bulbo-membranous part of the urethra, with the help of several injections performed in a circle, up to 8 ml of enriched fat micrograph is injected. After injection, a balloon catheter is inserted into the urethra for approximately 24 hours.

Disadvantages:

1) this method is used only for stress urinary incontinence.

Tasks:

1) to develop a method for the treatment of residual urinary incontinence, which prevents the infection of a previously established artificial sphincter of the bladder;

2) expand the indications for the use of endoscopic administration of enriched fat micrograph for the treatment of residual urinary incontinence after implantation of an artificial bladder sphincter.

To solve the tasks with the help of an endoscope, an injection needle is brought into the area of the cuff of the artificial sphincter. Through a needle, up to 8 ml of an enriched fat micrograph is injected into a submucous layer of the urethra to a depth of 2 mm using several injections performed in a circle. After injection, a balloon catheter is inserted into the urethra for approximately 24 hours.

In relation to the closest analogue of the claimed method has the following technical result. The use of the proposed method for the treatment of residental urinary incontinence after implantation of an artificial urethral sphincter allows adequate treatment of residental incontinence and to exclude the possibility of infection of a previously established artificial sphincter of the bladder.

The method is as follows.

First, adipose tissue is taken by liposuction. This manipulation can be performed under local anesthesia under dressing conditions. A small incision or puncture (not more than 0.5 cm) is made through anesthetized skin and a moisturizing solution (usually Hartmann's solution or Ringer's solution, with the addition of lidocaine for local anesthesia and adrenaline to narrow the blood vessels), is injected into the subcutaneous space. After 15 minutes, a 3 mm suction cannula is inserted into the subcutaneous space and the adipose tissue is aspirated into the syringe. The volume of aspirated adipose tissue is about 100 ml. The whole procedure takes about 30 minutes. The resulting adipose tissue is placed in sterile tubes with a special medium that supports tissue viability, and is delivered to the laboratory within 15 minutes. In the laboratory, under sterile conditions, adipose tissue is treated with collagenase enzyme, which breaks down fat cells. After enzymatic treatment, the split adipose tissue is removed, and the cells of the stromal-vascular fraction are washed with physiological saline. After 3-fold washing, the cells are divided into 3 parts. The first part of the cells is used to count their number, assess viability and conduct sterility tests. The second part is diluted with a cryopreservative medium, poured into special tubes for low-temperature storage and frozen in a cryobank at a temperature of -196 ° C. The third part of the cells is placed in a sterile tube, packaged, labeled and delivered to the operating room for subsequent administration. Fat obtained by liposuction is settled upright in syringes, then the liquid part is removed. After that, Ringer's solution is collected in syringes with fat, the fat settles, and the liquid drains. Thus, the fat is washed 3-5 times. Then the washed fat is placed on a sterile metal strainer and rubbed through it with a metal spatula. The fat thus homogenized is collected in syringes for administration. To obtain an enriched fat micrograph, SVF is added to the washed fat in the syringe.

The fat / SVF ratio is determined based on the volume of liposuction. Graft and SVF are mixed in a ratio of 1: 1 or 1: 2. For example, SVF obtained from 100 ml of adipose tissue should be mixed with 100 ml of fat graft.

It is possible to prepare fat grafts in a closed disposable system for washing fatty tissue “Puregraft”. Then, using an endoscope, an injection needle is brought into the area of the cuff of the artificial sphincter. Through a needle, up to 8 ml of an enriched fat micrograph is injected into a submucous layer of the urethra to a depth of 2 mm using several injections performed in a circle. At the end of the main stage, the Foley urethral catheter No. 14 according to Sharyer is installed in the bladder, the last is removed one day after the manipulation and self-urination is restored.

The distinctive advantages of the proposed method is the adequate treatment of residual incontinence and the exclusion of the possibility of infection of a previously established artificial bladder sphincter.

The inventive method of treatment of residual urinary incontinence has been tested clinically.

After implantation of an artificial bladder sphincter using an endoscope, 10 patients with resident urinary incontinence performed the introduction of an enriched fat micrograph into the submucous layer of the urethra, in the cuff standing area. All patients were discharged on day 3 without complications. When observing patients for 12 months (after surgical treatment) based on clinical and instrumental examination of data, urinary incontinence was not detected.

Clinical example: Patient I., 35 years old, was admitted to the hospital with complaints of urine leakage during physical exertion, sneezing, coughing. A history of radical prostatectomy for prostate cancer. Urinary incontinence. Condition after implantation of an artificial bladder sphincter. Resident urinary incontinence. On examination: The condition is satisfactory. According to uroflowmetry, it is not an obstructive type of urination with Qmax - 17 ml / sec. Data from a 24-hour test with pads for 4 days - daily urine loss is 300 (g). Diagnosed with residual stress urinary incontinence. The patient underwent endoscopic introduction of an enriched fat micrograph into the submucous layer of the urethra, in the cuff's standing zone. At the end of the main stage, the Foley urethral catheter No. 14 according to Sharyer is installed in the bladder, the last is removed one day after the manipulation, independent urination is restored. After manipulations on the urethra, the patient was repeatedly examined. 12 months after surgery, the condition is satisfactory, no complaints, no data on urinary incontinence.

Thus, the application of the proposed method allows the treatment of resedual urinary incontinence after implantation of an artificial sphincter of the bladder.

Socio-economic importance. The developed method can significantly reduce the risk of recurrence of urinary incontinence and infection of a previously established artificial bladder sphincter with the use of this technique, to improve the immediate and long-term results of treatment of urethral pathology.

Claims (1)

A method for treating residual urinary incontinence after implantation of an artificial sphincter, characterized in that a fat graft enriched in the stromal-vascular fraction is introduced into the submucous layer of the urethra, around the standing area of the cuff of the artificial sphincter of the bladder.