Sacrospinous ligament fixation combined with cystocele repair versus Elevate Anterior procedure in treatment of primary prolapse.
- Conditions
- Pelvic organ prolapse. Surgery. Mesh. Recurrence. Sexual Function.Vaginale verzakking. Chirurgie. Mesh/implantaat. Recidief. Seksuele functie.
- Registration Number
- NL-OMON25045
- Lead Sponsor
- niversity Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Sexually active women with a primary apical and anterior compartment prolapse stage 2 or more requiring surgery. Patients with co-existing posterior defects or concomitant perineal surgery (perineoplasty) can be included
Exclusion Criteria
1. Previous prolapse surgery;
2. Enterocele stage 2 or more after hysterectomy (performed for other reasons than prolapse);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life related to pelvic floor function at one year after intervention measured using UDI, DDI and IIQ questionnaires.
- Secondary Outcome Measures
Name Time Method Sexual function measured using the PISQ-12, POP-Q, morbidity (including post-operative pain, complications and recovery of normal daily activities), generic quality of life, repeated pelvic floor surgery within 12 months after intervention and cost analysis.