Een onderzoek naar de kosten en effectiviteit van de mid-urethrale slingoperatie in vergelijking met bulkinjecties bij vrouwen met stressincontinentie.
Recruiting
- Conditions
- Stress urinary incontinence
- Registration Number
- NL-OMON21563
- Lead Sponsor
- Amsterdam University medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Subject is female
Exclusion Criteria
1. Subject has predominating urge incontinence
2. Subject has a genital prolapse with a POP-Q score of point Aa or Ba >/=0
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is subjective improvement assessed by the 1-item questionnaire ‘Patient Global Impression of Improvement’ (PGI-I) (Appendix A). The PGI-I has a 7-point Likert scale with a response range from ‘very much worse’ to ‘very much better’. Improvement is considered to be clinically significant when answers to the PGI-I are either much better” or very much better”. Subjective improvement will be assessed at 4-6 weeks, 6 months and 12 months.
- Secondary Outcome Measures
Name Time Method