RU2629717C2 - Method of low-invasive treatment of urinary incontinence - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: rear urethrovesical angle uis measured by a vaginal probe before the low-invasive treatment of urinary incontinence. A volume-forming substance is injected into the lacunar tissue of proximal urethra and vesicourethral segment. Doses of 0.3-0.5 ml of the volume-forming substance are administered using a 0.45 mm thick, 35 mm long straight needle under unltrasound supervision, with simultaneous measurement of the urethrovesical angle. Bringing this angle to the normal value is the criterion for termination of administration.

EFFECT: method provides controlled, efficient, low-invasive correction of urinary incontinence without surgery, by restoring the anatomical and physiological position of the urethra-vesical segment.

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Description

The invention relates to medicine, namely to gynecology and urology, and is intended for the treatment of stress urinary incontinence in women.

Urinary incontinence in women is one of the most common diseases in female urology and urogynecology [1, 2]. In recent years, significant success has been achieved in the treatment of this condition, which is associated, first of all, with the widespread introduction into clinical practice of operations using free suburethral synthetic loops [3]. Despite this, many questions regarding urine retention mechanisms remain unclear. Moreover, according to various authors, recurrence of urinary incontinence after surgical treatment reaches 20% [4]. The issues of eliminating urinary incontinence in patients of childbearing age, when the use of synthetic prostheses are not always desirable, remain open. Moreover, in March 2013, the US Federal Agency for the Control of Medicines and Foods (Food and Drug Administration, English) issued a resolution warning of possible adverse events when using synthetic materials for the treatment of urinary incontinence in women [5]. These and other facts make it relevant to further search for alternative and minimally invasive treatment for heart failure.

A sign of stress urinary incontinence (CHM) in women is the displacement of the urethro-cystic segment downward and posteriorly at the time of increasing intra-abdominal pressure, resulting in the opening of the urethra and leakage of urine [6, 7, 8, 9]. An objective confirmation of the pathological mobility of the neck of the bladder and urethra, as well as the opening of the urethra during physical exertion - a sign of stress urinary incontinence - is visualization of the lower urinary tract using dynamic transperineal ultrasound [10, 11, 12, 13].

Since the choice of treatment method depended on the type of urinary incontinence, we present the international classification recommended by ICS (International Committee Society).

Stress incontinence, type 0:

a) at rest, the bottom of the bladder is located above the pubic symphysis;

b) when coughing in a standing position, a slight turn and dislocation of the urethra and the bottom of the bladder are determined: when the neck of the bladder is opened, spontaneous excretion of urine is not observed.

Stress incontinence, type 1:

a) at rest, the bottom of the bladder is located above the pubic symphysis;

b) when straining, the bottom of the bladder is lowered by about 1 cm, when opening the neck of the bladder and urethra, involuntary discharge of urine is noted: cystocele may not be detected.

Stress incontinence, type 2a:

a) at rest, the bottom of the bladder is at the level of the upper edge of the pubic symphysis;

b) when coughing, a significant omission of the bladder and urethra below the pubic symphysis is noted: with wide opening of the urethra, spontaneous excretion of urine is noted; determined by cystocele.

Stress incontinence, type 2b:

a) at rest, the bottom of the bladder is below the pubic symphysis;

b) when coughing, a significant omission of the bladder and urethra is determined, which is accompanied by spontaneous excretion of urine: cystourethrocele is determined.

Stress urinary incontinence type 3:

at rest, the bottom of the bladder is slightly lower than the upper edge of the pubic joint: the neck of the bladder and the proximal urethra are open at rest, in the absence of contractions of the detrusor: spontaneous excretion of urine is noted due to a slight increase in intravesical pressure.

As can be seen from the above classification, in case of urinary incontinence of types 0, 1 and 2, the normal urethrovesical segment and the proximal part of the urethra are dislocated, in contrast to type 3 urinary incontinence, in which the urethra and bladder neck do not function as a sphincter, the urethrovesical segment is scarred .

We are interested in the urinary incontinence of types 0.1 and 2, 2a. Ultrasonography is used to determine the urethrovesical segment [14].

Ultrasound performed by perineal or vaginal access, allows you to obtain data corresponding to clinical symptoms, and in most cases allows you to limit the use of x-ray studies (in particular, urethrocystography).

- The diagnostic capabilities of transvaginal ultrasonography are quite high and are of independent importance for clarifying the dislocation of the urethrovesical segment and diagnosing sphincter insufficiency in patients with stress incontinence. With perineal scanning, one can determine the localization of the bottom of the bladder, its relation to the upper edge of the womb, measure the length and diameter of the urethra along the entire length, the posterior urethrovesical angle (β) and the angle between the urethra and the vertical axis of the body (α), evaluate the configuration of the bladder neck, urethra, the position of the neck of the bladder in relation to the symphysis.

To date, there are various methods of treating stressful NM: conservative and surgical.

Conservative methods are, first of all, behavioral therapy, including pelvic floor muscle training, including in biological feedback mode, modern antidepressants from the group of serotonin and noradrenaline reuptake inhibitors, etc. They are effective only in case of mild stressful NM, and also require high motivation from patients and readiness for repeated courses of treatment.

Of the surgical methods, minimally invasive, in the form of various modifications of sling operations, are currently most preferred. But not always their use leads to the disappearance of symptoms of stressful NM, in some cases an average of 6% leads to the appearance of imperative de novo. In addition, the factors limiting the use of this method are the presence of synthetic material, transient urinary retention, bleeding, hematoma formation, the risk of perforation of the bladder, the presence of wound infection, and a rather high cost [15].

Given the current trend toward minimizing surgical aids, the use of volume-forming agents as an alternative to minimally invasive surgery is becoming increasingly important.

In foreign and domestic literature there are numerous data on the use of various volume-forming agents, such as auto-fat, collagen, silicone, zirconium balls, Teflon, etc., which had a number of drawbacks: migration to distant organs and tissues, inflammatory processes at the injection site, the possibility of allergic reactions , short therapeutic effect and technical complexity of the administration procedure.

There is a physiotherapeutic method for treating stressful and mixed NM in women, which consists in exposure to electric currents with a carrier frequency in the range of 2-200 Hz and an amplitude of 0-90 mA [16].

The effectiveness of this method of treating stressful NM is 35% and, unfortunately, is extremely low with mixed NM.

Known polyacrylamide hydrogel that does not have a cytotoxic effect on human fibroblasts. It is non-toxic, not a carcinogen, allergen and mutagen; resistant to enzymatic and microbiological cleavage. In addition, the polymer is not soluble in water. This hydrogel is useful as a material for endoprostheses [17].

Closest to the proposed method is a method that includes electrical stimulation of periurethral tissues and further introduction of dextranomer / hyaluronic acid into the submucosal of the urethra [18].

The disadvantage of the proposed known substances is that in all the proposed options, the substances are introduced into the submucous layer of the urethra transurethrally (the external opening of the urethra), which, in turn, is not pathogenetic justified, since they do not affect the mechanisms of incontinence, according to hammock ”, in women [19].

Thus, it seems relevant to create a method for minimally invasive treatment of stress urinary incontinence by introducing volume-forming substances into the proximal urethra in the projection of the ligamentous apparatus of the bladder neck.

The objective of the invention is a method of treating urinary incontinence, which has no side effects and has a minimum of contraindications, which has a shorter duration.

The task is achieved in that, subject to the rules of aseptic and antiseptic methods for minimally invasive treatment of urinary incontinence, including injection of a volume-forming substance into the paraurethral tissues of the proximal urethra, according to the invention, the posterior urethrovesical angle is measured with a vaginal sensor and a straight needle with a thickness of 0 under local anesthesia, 45 mm, a length of 35 mm is injected in a dosage of 0.3-0.5 ml of a volume-forming substance in the region of the posterior urethravesical angle, while measuring the angle. The criteria for changing the angle consider the change in the posterior urethrovesical angle close to normal.

Achievable technical result is the development of a method for minimally invasive treatment of stress urinary incontinence by introducing volume-forming substances into the paraurethral tissues of the proximal urethra without surgical intervention (dissection) in the study area.

In FIG. 1 presents an ultrasound scan before administration of the drug: 1 - diameter of the urethra; 2 - pubic-urethral distance; 3 - urethro-vesical angle. In FIG. 2 presents an ultrasound scan immediately after administration of the drug: 1 - diameter of the urethra; 2 - pubic-urethral distance; 3 - urethro-vesical angle; 4 - introduced volume-forming substance (gel of high density hyaluronic acid, particle size 1400 μm, molecular weight 3 mDA). In FIG. 3 presents a control ultrasound examination 3 months after administration of the drug: 1 - diameter of the urethra; 2 - pubic-urethral distance; 3 - urethro-vesical angle; 4 - introduced volume-forming substance (gel of high density hyaluronic acid, particle size 1400 μm, molecular weight 3 mDA).

The proposed method is as follows.

The position of the patient in a pose for stone cutting. The bladder is preliminarily filled with Foley catheter 200 ml of physiological saline.

Manipulation is carried out in compliance with the rules of asepsis and antiseptics. Applied local anesthesia 30 minutes prior to the procedure was used for pain relief. Previously, during the ultrasound, the posterior urethrovesical angle was measured. Then, following the rules of aseptic and antiseptic, injections were made using the puncture method transvaginally into the paraurethral tissues of the proximal part of the urethra and bladder neck under ultrasound control. 0.3-0.5 ml of volume-forming substance was administered in a dosage and the posterior urethrovesical angle was measured. The introduction was stopped after reaching an angle close to normal. A follow-up examination was performed after 1 and 3 months, and with insufficient compliance with the posterior urethravesical angle, an additional correction was performed.

Clinical example.

Patient L.K., 25 years old, suffers from urinary incontinence with tension for 1.5 years. The cough test is positive, the Valsalva test is positive. (Figure 1).

- the diameter of the urethra is 7.77 mm, with a voltage of 8.43;

- pubic-urethral distance 29.73 mm, with a voltage of 35.64 mm;

- the posterior urethrovesical angle is initially 127 degrees, at a voltage of 135 degrees;

- urethral mobility is insignificant within 3-5 mm.

The patient was injected with paraurethral tissues and in the posterior urethrovesical angle 1 ml of a volume-forming substance (high-density hyaluronic acid gel, particle size 1400 μm, molecular weight 3 mDA). After the procedure:

- the pubic-urethral distance was 21.47 mm, with a voltage practically unchanged;

- the posterior urethrovesical angle was 107 degrees, at a voltage of 112 degrees;

- the diameter of the urethra is 4 mm, with voltage, the diameter of the urethra has not changed;

- urethral mobility is negligible within 2 mm (Fig. 2).

Observation of the patient after 2 weeks showed a persistent clinical effect:

The patient holds urine during exertion (cough, laughter, physical activity). Valsalva's test is negative.

Further monitoring of the patient (after 1 month) showed the preservation of the therapeutic effect.

Monitoring of the patient after 3 months:

- diameter of the urethra 5 mm;

- pubic-urethral distance of 22.1 mm, with a voltage of 22.8 mm;

- posterior urethrovesical angle of 101 degrees, with a voltage of 106 degrees;

- urethral mobility at a voltage within 2-3 mm (Fig. 3).

Information sources

1. Lopatkin N.A. Guide to Urology. // M., 1998 .-- S. 148-163.

2. Laurent O. B. Incontinence in women // Doctor. 2000. - No. 4. - S. 13-15.

3. Laurent O. B., Pushkar D. Yu., Godunov B. N. Current opportunities for reconstruction of the urethra in women and restoration of urine retention // Russian Bulletin of the Obstetrician-Gynecologist. - 2008. - T. 8. - No. S9. - S. 38.

W, et al.: Standardisation of urethral pressure measurement: report from the Standardfdaisation Sub-Committee of the International Continence Society. Neurourol Urodyn. 2002; 21: 258-60.4. Lose G, Griffiths D, Hosker G, Kulseng-Hanssen S, Perucchini D,

W, et al .: Standardization of urethral pressure measurement: report from the Standardfdaisation Sub-Committee of the International Continence Society. Neurourol Urodyn. 2002; 21: 258-60.

5. Medical devices: information for patients with SUI. US Food and Drug Administration Web site. http://www.cfd.gov/Medical Devices / ProductsandMedicalProcedures / ImplantsandProsthetics / UroGynSurgicalMesh / ucm345230.htm. Updated March 27, 2013.

6. Algorithms for the diagnosis and surgical treatment of patients with urinary incontinence: Proceedings of the V All-Russian Conference “Urinary Disorders in Women”. - Moscow, May 22-23, 2006 / E.K. Aylamazyan [et al.]. - Moscow, 2006 .-- S. 17-18.

7. Alyaev Yu.G. Disorders of urination / Yu.G. Alyaev, V.A. Grigoryan, Z.K. Gadzhieva. - Moscow: Litterra, 2006. - 207 p.

8. Clinical recommendations. UROLOGY / N.A. Lopatkin [et al.]; under the editorship of ON. Lopatkina. - Moscow: GEOTAR-Media, 2007. - 348 p.

9. Perineology / V.E. Radzinsky [et al.]; edited by V.E. Radzinsky. - Moscow: Medicine, 2006 .-- 330 p.

10. Savitsky, G.A. Urinary incontinence due to stress in women / G.A. Savitsky, A.G. Savitsky. - St. Petersburg: "ELBI - St. Petersburg", 2000. - 120 p.

11. Buzelin, J.M. Les echecs de la chirurgie de i'incontinence urinaire chez la femme / J.M. Buzelin [et al.] // Urodynamique Neurol. Urol. - 1990. - Vol. 2. - P. 11-21.

12. Goeschen, K. Der weibliche Beckenboden Funktionelle Anatomie, Diagnostik und Therapie nach der Integralteorie / K. Goeschen, P. Petros. - Heidelberg: Springer Medicin Verlag, 2009 .-- 278 s.

13. Koonings, P.P. Low urethral pressure and stress urinary incontince in women: risk factor for failed retropubic surgical procedure / P.P. Koonings [et al.] // Urology. - 1990. - Vol. 36. -: P. 248-252.

14. Diagnosis of types of urinary incontinence in women with genital prolapse, V.I. Krasnopolsky, S.N. Buyanova, V.D. Petrova, V.I. Balashov http://medi.ru/doc/8690310.htm

15. Laurent O.B. et al., 2006.

16. The clerk B.C., 2005, Orzheshkovsky V.V., 1984.

17. Patent No. 2301814, A61L 27/16, published June 27, 2007.

18. Patent No. 2424005. A61K 31/728, published July 20, 2011.

19. Kasyan G.R. Moscow, 2014, the dissertation “FUNCTIONAL BASES OF URINE CONTINUITY IN WOMEN”.

Claims (1)

A method for minimally invasive treatment of urinary incontinence, including the injection of a volume-forming substance into the paraurethral tissues of the proximal urethra, characterized in that the posterior urethrovesical angle is preliminarily measured with a vaginal sensor, after application of local anesthesia under U3 control with a straight needle 0.45 mm thick, 35 mm long injected in a dosage of 0.3-0.5 ml of a volume-forming substance in the region of the posterior urethravesical angle, while measuring the angle, moreover, before and after the injection, they monitor cession by ultrasound, and the criteria for discontinuation of think bringing this angle to the normal value.

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