Pessary or prolapse surgery for symptomatic pelvic organ prolapse
- Conditions
- -Symptomatic pelvic organ prolapse.-Verzakking van bekkenorganen met klachten.-Pessary, prlapse surgery.-Pessarium, ring. Verzakkingsoperatie, prolapsoperatie.
- Registration Number
- NL-OMON29535
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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).
Exclusion Criteria
1. Prior urogynaecological (prolapse or incontinence) surgery
2. Probability of future childbearing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global impression of improvement of POP symptoms at 24 months measured with PGI-I.
- Secondary Outcome Measures
Name Time Method • Changes in symptom bother and disease-specific quality of life at 12 and 24 months follow-up<br /><br>• Changes of sexual function at 12 and 24 months follow-up<br /><br>• Changes in general quality of life at 3, 6, 12 and 24 months of follow up<br /><br>• Adverse events/complications related to both treatment strategies during the study period<br /><br>• Development of prediction model to identify factors for failing of pessary and surgery.<br /><br>• Costs-effectiveness analyses