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Women-UP trial


- candidate number24220
- NTR NumberNTR5838
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2016
- Secondary IDs2016_132 METC AMC Amsterdam
- Public TitleWomen-UP trial
- Scientific TitleSERIOUS GAME-ENHANCED BIOFEEDBACK SUPPORTED SELF-MANAGEMENT VERSUS PELVIC PHYSIOTHERAPY IN WOMEN WITH MILD TO MODERATE STRESS URINARY INCONTINENCE – A MULTINATIONAL, NON-BLINDED RANDOMIZED CONTROLLED TRIAL
- ACRONYM
- hypothesisPelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal is non-inferior to pelvic floor muscle training alone.
- Healt Condition(s) or Problem(s) studiedStress urinary incontinence
- Inclusion criteria- Women between 18 and 75 years old
- Symptoms of mild or moderate stress urinary incontinence more than once a week (ICIQ-IU-short form index score ranging from 1 to 12).
- Exclusion criteria1. 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 training (PFMT) for urinary incontinence in the previous 12 months
5. Subjects with genital prolapse more than 1 cm beyond the plane of the hymen (simplified POP-Q stage stage 3 or more, ICS-IUGA 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 (Appendix Q)
9. Woman unable to contract her pelvic floor muscles (Oxford = 0 or EMG-measure)
10. History of chronic neurological condition, like spinal cord injury, multiple sclerosis, cerebro-vascular incidents.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate1-jul-2018
- Target number of participants300
- InterventionsIntervention: Pelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal
Control: Usual care pelvic floor muscle therapy
- Primary outcomePatient reported improvement of SUI symptoms
- Secondary outcome1. Patient reported cure of SUI symptoms
2. Incontinence related quality of life
3. Generic quality of life / Utility
4. Indication for SUI-surgery during follow-up
5. Patient satisfaction
6. Resource use / Costs
7. Performance of pelvic floor
8. Adherence to treatment
9. Treatment-related adverse events
10. Serious Adverse Device Events (SADE’s)
- Timepoints- T-1: Screening visit
- T0: Baseline visit
- T1: 6-8 weeks
- T2: 12-14 weeks (end of treatment)
- T3: 50-52 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Commission
- Publications
- Brief summaryRandomized controlled trial, hypothesizing that pelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal is non-inferior to pelvic floor muscle training alone.
- Main changes (audit trail)
- RECORD11-apr-2016 - 22-jun-2016


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