Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT06673875
- Lead Sponsor
- Brno University Hospital
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
stress urinary incontinence
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination Assessment of pelvic floor muscle rehabilitation training to change the clinical severity of urinary incontinence using the questionnaire - International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-UI SF - range 0 to 21) at at time of initial urogynecology examination / after 8 weaks of training / and after 4 months of training/ at the time of output urogynecology examination - in the group with home exercises using the medical device Aniball-inco ( 1st group) vs. exercise of the pelvic floor muscles after education by a physiotherapist (2nd group).
- Secondary Outcome Measures
Name Time Method objective urodynamics parameters baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination evaluation of changes in urodynamic parameters before pelvic floor muscle training at at time of initial urogynecology examination and after 4 months of training at the time of output urogynecology examination. We will assess the rate of maximum urethral closure pressure (MUCP cmH2O) in two monitored groups.
objective measured parameters of urine leakage. baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination Evaluation of the rate of urine leakage using a one-hour pad-weight test (grams). The test is standardised by ICS (International Continence Society).
The total amount of urine leaked is determined by weighing the pad. The test is performed before training before pelvic floor muscle training at time of initial urogynecology examination and after 4 months of training at the time of output urogynecology examination.
Trial Locations
- Locations (1)
University Hospital Brno
🇨🇿Brno, Czech Republic, Czechia