Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence

Обзор

The eim is to evaluate the clinical effectiveness of pelvic floor muscle training (PFMT) in conservative therapy in women with objective, urodynamic stress urinary incontinence using home exercise training with the medical vaginal device versus standard pelvic floor muscle training-exercises

Подробное описание

The first group were using vaginal device - commercial name Aniball INCO®, which is controlled by the Czech State Institute of Drug Control which is registered by the European Medical Device Nomenclature (EMDN) with Unique Device Identifier - Device Identifier (UDI-DI) - 859418371002LA

The second group - the education was provided by certified physiotherapist trained in pelvic floor disroder

Вмешательства

• Процедура conservative treatment of stress urinary incontinence - pelvic floor muscle training
  evaluation of pelvic floor muscle rehabilitation to change the clinical severity of urinary incontinence
• Устройство vaginal device Aniball INCO
  the firt group - the pelvic floor muscle training with vaginal device Aniball INCO according manual after education by the urogynecologist, who is educated in pelvic floor dysfunction. the second group - the pelvic floor muscle training without vaginal device, the education was performed by certified physiotherapist trained in pelvic floor disorder.

Первичные конечные точки

• International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire [Срок оценки: baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination]

Вторичные конечные точки (2)

• objective urodynamics parameters [Срок оценки: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination]
• objective measured parameters of urine leakage. [Срок оценки: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination]

Критерии участия

Inclusion Criteria: stress urinary incontinence

Exclusion Criteria: age under 18, age over 80, ISD (Intrinsic Sphincter Deficiency), descent of the pelvic organs according to POP-Q ≥ 2 (stage), urgent incontinence ruled out using a questionnaire (OAB V8 - overactive bladder < 7a PPIUS - patient perception of intensity and urgency scale ≤ 1), overactive bladder (OAB) with the use of anticholinergics, pregnant women and women up to 6 months after childbirth, active pelvic cancer, degenerative neurological or myofascial disease, reduced cognitive function that does not allow understanding the principles of the study, impossibility of contraction mm.levatores ani., recurrent vaginal inflammation, atrophic vulvovaginitis, irregular bleeding, contraindications listed by the manufacturer of the medical device Aniball inco.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• University Hospital Brno — Brno

Идентификаторы

NCT: NCT06673875 · Aniball inco

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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