Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Brno University Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Martina Szypulova
Doctor of Medicine, gynecologist, urogynecologist, principal investigator
Brno University Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire
Time Frame: 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 Outcomes
- objective urodynamics parameters(baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination)
- objective measured parameters of urine leakage.(baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination)