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

Phase 3

Completed

Conditions: stress-urine-incontinentie
involuntary loss of urine
stress urinary incontinence

Registration Number: NL-OMON47256

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Subjective improvement of SUI symptoms</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Objective cure of SUI symptoms<br /><br>2. Incontinence related quality of life<br /><br>3. Generic quality of life<br /><br>4. Indication for SUI-surgery during follow-up<br /><br>5. Patient satisfaction<br /><br>6. Costs<br /><br>7. Performance of pelvic floor<br /><br>8. Adherence to treatment<br /><br>9. Treatment-related adverse events<br /><br>10. Serious Adverse Device Events (SADE*s)</p><br>