NL-OMON47256CompletedPhase 3
Serious game-enhanced biofeedback supported self-management versus standardized pelvic physiotherapy in women with mild to moderate stress urinary incontinence - A multinational, non-blinded randomized controlled trial - WOMEN-UP
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Women between 18 and 75 years old
- •- Symptoms of mild or moderate stress urinary incontinence
Exclusion Criteria
- •1. Mixed urinary incontinence (MUI) with a predominance of urge urinary incontinence.
- •2. Subjects who are not able to give informed consent, due to legal incapability or history or current major psychiatric illness (as subjectively assessed by a physician).
- •3. Subjects who are pregnant
- •4. Subjects who underwent specialized pelvic floor muscle therapy (PFMT) for urinary incontinence in the previous 12 months
- •5. Subjects with genital prolapse beyond the hymen (Baden-Walker grade 3 or 4). prolapse stage 2 or more according to the POP-Q classification.
- •6. History of recurrent lower urinary tract infection (>4 times/year)
- •7. Insufficient knowledge or understanding of the Dutch / Spanish / Finnish language
- •8. Insufficient score on the IT-knowledge questionnaire
- •9. Woman unable to contract her pelvic floor muscles (Oxford = 0)
- •10. History of chronic neurological condition, like spinal cord injury, multiple sclerosis, cerebro-vascular incidents.
Investigators
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