Pessary or surgery for symptomatic pelvic organ prolapse
Completed
- Conditions
- Prolapse10029903
- Registration Number
- NL-OMON47134
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 436
Inclusion Criteria
1. Women with a prolapse stage 2 or more.
2. Women with moderate to severe POP symptoms. Moderate to severe POP symptoms is defined as a prolapse domain score > 33 on the validated Dutch version of the Pelvic Floor Distress Inventory (PFDI-20).
3. Women who have had a successful pessary fitting procedure: for the RCT.
4. Written informed consent
Exclusion Criteria
1. Prior urogynaecological (prolapse or incontinence) surgery
2. Probability of future childbearing
3. Insufficient knowledge of the Dutch language
4. Co-morbidity causing increased surgical risks
5. Major psychiatric illness
6. Prior pessary use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method