Sacrospinous ligament fixation versus Elevate Posterior procedure in treatment of primary apical prolapse stage * 2: a multi-center randomised controlled trial.
Completed
- Conditions
- Pelvic organ prolapse1003861210029903
- Registration Number
- NL-OMON37357
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Sexually active women with a primary apical compartment prolapse stage * 2 requiring surgery.
Exclusion Criteria
- Previous prolapse surgery
- Enterocele stage * 2 after hysterectomy (performed for other reasons than prolapse)
- Known malignancy
- Pregnancy or wish to become pregnant
- Unwilling to return for follow-up or language barriers
- Presence of immunological / haematological disorders interfering with recovery after surgery
- Abnormal ultrasound findings of uterus or ovaries.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Quality of life related to pelvic floor function measured using validated<br /><br>disease-specific quality of life questionnaires (UDI, DDI, IIQ) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Sexual function at one year after intervention measured using the PISQ-12<br /><br>questionnaire, POP-Q, morbidity (including post-operative pain, complications<br /><br>and recovery of normal daily activities), generic quality of life, repeated<br /><br>pelvic floor surgery within 12 months after intervention and cost analysis. </p><br>