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.
ID
Bron
Verkorte titel
Aandoening
Stress urinary incontinence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patient reported improvement of SUI symptoms
Achtergrond van het onderzoek
Randomized 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.
Doel van het onderzoek
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.
Onderzoeksopzet
- T-1: Screening visit
- T0: Baseline visit
- T1: 6-8 weeks
- T2: 12-14 weeks (end of treatment)
- T3: 50-52 weeks
Onderzoeksproduct en/of interventie
Intervention: Pelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal
Control: Usual care pelvic floor muscle therapy
Publiek
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Wetenschappelijk
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5599 |
| NTR-old | NTR5838 |
| Ander register | METC AMC Amsterdam : 2016_132 |