RU2424005C1 - Method of treating stress and mixed urinary incontience in females - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: invention refers to urology, gynaecology, physiotherapy. A method involves electrical stimulation of periurethral tissues. The electrical stimulation is ensured by a vaginal sensor. The patient is exposed to current of the frequency 12-35 Hz, pulse duration 200-400 mcS. The exposure length is 25-30 minutes. The therapeutic course is 10-15 sessions. The electrical stimulation is followed with the introduction of dextranomer/hyaluronic acid in a submucous layer of the middle one-third of urethra. In 15-20 days after the introduction of said dextranomer is followed with another electrical stimulation in said modes in number of 5-10 sessions. ^ EFFECT: method provides higher clinical effectiveness, prolongs the remission due to charged dextranomer particle confinement and intensifies the formation of proper collagen fibres in an introduction place. ^ 1 ex

Description

The present invention relates to medicine, namely to the section urogynecology, and is intended for the treatment of stress and mixed types of urinary incontinence (NM) in women.

Urinary incontinence (NM) in women is an urgent medical and social problem. The results of recent epidemiological studies on the example of residents of a metropolis reflect the following data: at the age of 25-34 years, the incidence of NM is 9%, increasing after 55 years to 36% [Apolikhina IA, 2006]. According to foreign authors [Abrams P., 2003], the prevalence of symptoms of NM in women in the world reaches 37%.

The Standardization Sub-committee of the International Continence Society stressful NM is defined as involuntary loss of urine resulting from increased intra-abdominal pressure as a result of physical exertion, coughing, sneezing, heavy lifting, etc.

Stressful NM causes severe discomfort and significantly complicates the full-fledged life of women in society. Most of them are left without timely and adequate examination and treatment due to the low circulation and lack of awareness of women about the treatment options for this disease.

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 for mild stressful NM, and also require high motivation from patients and readiness for long 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 [Laurent O. B. et al., 2006].

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 known 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 (Ulashchik B.C., 2005, Orzheshkovsky VV, 1984).

The effectiveness of this method of treating stressful NM is 35% and, unfortunately, is extremely low with mixed NM (Vo K, 1999).

Currently, there is a new dextranomer / hyaluronic acid volume-forming agent for the treatment of NM by periurethral injection. It consists of positively charged microparticles of dextranomer, which stimulate the formation of their own collagen fibers, and hyaluronic acid, which is a vehicle for these microparticles. According to foreign authors, the effectiveness of the use of this tool in the treatment of stressful and mixed NM with a predominance of the stress component is 55% [Chapple C.R. et al., 2005].

The disadvantage of this method is the nature of the temporary effect, which is possibly associated with biodegradation and its removal from the periurethral region.

The objective of the invention is to increase efficiency by increasing the duration of the effect of treating stress and mixed urinary incontinence in women.

The problem is solved by the method consisting in the fact that they conduct electrical stimulation of periurethral tissues with a vaginal probe, an electric current with a frequency of 12-35 Hz, a pulse duration of 200-400 μs for 25-30 minutes 10-15 sessions, followed by the introduction into the submucous layer of the middle third urethra "dextranomer / hyaluronic acid" and the repetition of electrical stimulation above the specified modes 15-20 days after the introduction of 5-10 sessions.

Improving the efficiency of the proposed method, in our opinion, is that when a low-voltage electric current acts on positively charged particles of the dextranomer, they are retained and enhances the synthesis of their own collagen fibers at the injection site.

In practice, the method is as follows:

Stage I: electrical stimulation of the periurethral region with a vaginal sensor, an electric current of 12-35 Hz, a pulse duration of 200-400 μs for 25-30 minutes is carried out with an empty bladder in the amount of 5-10 sessions.

Stage II:

The procedure for introducing a volume-forming agent into the periurethral space is performed in a small operating room in the position of the patient lying on the gynecological chair.

When the bladder is empty, the length of the urethra is measured using a Foley catheter No. 16. Then the catheter is compared with the Luer applicator, which is a guide for the injection needle and helps to more accurately get it into the submucous layer of the middle third of the urethra.

Under intravenous or local anesthesia, 2 ml of instillagel is injected into the urethra. After 8 minutes, periurethral injections are made into the submucosal layer of the middle third of the urethra, at the points corresponding to 3, 6, 9 and 12 hours of the conditional dial. Dextranomer / hyaluronic acid is introduced under slight pressure through an oblique incision of the Luer applicator to avoid creating excessive pressure in the tissues, which can squeeze part of the material through the needle injection channel after it is removed. After the introduction of the bulking agent, the needle is slowly removed from the tissues, and similar injections are repeated at the following points. The total amount of drug administered is 4 ml. The time for this procedure is 15 minutes. After the introduction of the dextranomer / hyaluronic acid volume-forming agent, it is possible during the operation to evaluate the effectiveness of the ability to retain urine by asking the patient to cough. After the ability to urinate independently for 2 hours after the procedure, the patient can go home.

Stage III:

Repeated electrical stimulation of the periurethral region with the above modes after 15-20 days after the introduction of funds in the amount of 5-10 sessions.

The following example illustrates the method of the invention:

Patient V.V., 38 years old, with a history of moderate stress urinary incontinence for 3 years, the appearance of these symptoms was noted after the last delivery, complicated by rupture of the perineum of the II degree. During the day uses 2-3 pads. The patient underwent electrical stimulation of the periurethral region with an electric current with a frequency of 30 Hz, a pulse duration of 400 μs for 30 minutes, in an amount of 12 sessions. Subsequently, the volume-forming agent dextranomer / hyaluronic acid was introduced into the submucosa of the middle third of the urethra under local anesthesia. 20 days after administration, repeated electrical stimulation of the periurethral region was performed in the above modes. The total number of sessions was 8.

During the treatment, clinical improvement was noted:

retention of urine when laughing, coughing, sneezing and physical exertion, reducing the number of day and night urination. Further monitoring of the patient after 1, 3 and 12 months showed the preservation of the therapeutic effect.

This method can be used to treat stress and mixed urinary incontinence in women.

The claimed method was used to increase efficiency by increasing the duration of the treatment effect in 40 women with stressful and mixed NM. The results of the study showed improvement in 84% of patients.

Information sources

1. Abrams P. The standardization of terminology of lower urinary tract function: report from the standardization sub-committee of the International Continence Society / P. Abrams, L. Cardozo, M. Fall et all. // Urology - 2003 .-- Vol.61. - 37-49.

2. In K, Talseth T, Holme I, Single blind, randomized controlled trial of pelvic floor exercise, electrical stimulation, vaginal cones and no treatment in management of genuine sui in woman. British Medical Journal, 1999, 318 (718), P. 487-593.

3. Chapple C. R, Haab F, Cervigni M, Dannecker C, Fianu-Jonasson A, Sultan A.H. An open, multicentre study of NASHA / Dx Gel (Zuidex) for the treatment of stress urinary incontinence // European Urology. - 2005. - Vol. 48. - P. 488-494.

4. Apolikhina I.A. Clinical epidemiology, differential diagnosis and conservative treatment of urinary incontinence in women. Abstract. diss ... Dr. med. sciences. - M., 2006.

5. Laurent O. B. Morphological characteristics of an overactive bladder // Consultum medicum. - 2006 - extra-release - p. 5-14.

6. Orzheshkovsky V.V. "Clinical Physiotherapy", Kiev, 1984 - 30-38.

7. Clerk B.C., I.V. Lukomsky “General Physiotherapy”, Minsk, 2005 - p.120-134.

Claims (1)

A method for the treatment of stress and mixed types of urinary incontinence in women, which consists in conducting electrical stimulation of periurethral tissues with a vaginal sensor, an electric current of 12-35 Hz, a pulse duration of 200-400 μs, for 25-30 minutes, in an amount of 10-15 sessions, followed by the introduction of a dextranomer / hyaluronic acid into the submucosal layer of the middle third of the urethra and repeated electrical stimulation by the above regimes 15-20 days after administration, in the amount of 5-10 sessions.