No registrations found.
ID
Source
Brief title
Health condition
Stress urinary incontinence
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient reported improvement of SUI symptoms
Secondary outcome
1. 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)
Background summary
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.
Study objective
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.
Study design
- T-1: Screening visit
- T0: Baseline visit
- T1: 6-8 weeks
- T2: 12-14 weeks (end of treatment)
- T3: 50-52 weeks
Intervention
Intervention: Pelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal
Control: Usual care pelvic floor muscle therapy
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
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
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 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 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5599 |
| NTR-old | NTR5838 |
| Other | METC AMC Amsterdam : 2016_132 |