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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of pessaries versus surgical interventions in pelvic organ prolapse management?
How does the use of a pessary compare to standard-of-care prolapse surgery in treating symptomatic pelvic organ prolapse?
Are there specific biomarkers that can predict patient response to pessary use or pelvic organ prolapse surgery?
What are the known adverse events associated with pessary treatment and how do they compare to surgical interventions for pelvic organ prolapse?
What combination approaches or alternative therapies are being explored alongside pessaries and prolapse surgery for pelvic organ prolapse?