Primary treatment of vaginal prolapse: Pessary use versus prolapse surgery.
Completed
- Conditions
- English:Pelvic Organ ProlapsePessaryProlapse surgeryDutch:ProlapsVerzakkingPessariumRingProlapschirurgie
- Registration Number
- NL-OMON24754
- Lead Sponsor
- Maxima Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. POP-Q stage grade 2-4 (POP-Q according to ICS);
2. Eligible for pessary treatment and prolapse surgery.
Exclusion Criteria
1. Isolated rectocele;
2. Previous prolapse treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be disease specific quality of life, which will be evaluated by using the urogenital distress inventory (UDI).
- Secondary Outcome Measures
Name Time Method 1. General quality of life and patients satisfaction rate. Both will be evaluated by using a validated questionnaire (werkgroepbekkenbodem, eurqol, SF-36);<br /><br>2. Successful continuous pessary treatment;<br /><br>3. Anatomical result. Evaluated through pelvic examination according to the recommendations of the ICS.