Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conservative treatment of stress urinary incontinence - pelvic floor muscle training, vaginal device Aniball INCO.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Procedure conservative treatment of stress urinary incontinence - pelvic floor muscle training
evaluation of pelvic floor muscle rehabilitation to change the clinical severity of urinary incontinence - Device 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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- objective urodynamics parameters [Time frame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination]
- objective measured parameters of urine leakage. [Time frame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- University Hospital Brno — Brno
Identifiers
NCT: NCT06673875 · Aniball inco