WOMEN-UP trial

SERIOUS 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29615

Enrollment

300

Registered

2016-04-11

Start date

2016-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence

Interventions

Intervention: Pelvic floor muscle training supported by vaginal and abdominal biofeedback, serious games and a web-portal Control: Usual care pelvic floor muscle therapy

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Patient reported improvement of SUI symptoms	—

Secondary

Measure	Time frame
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)	—

Contacts

Public ContactJan-Paul W.R. Roovers

PO Box 22660

j.p.roovers@amc.uva.nl+31 (0)20 5666429

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)