Sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure in treatment of primary apical and anterior compartment prolapse stage >= 2: a multi-center randomised controlled trial.
Completed
- Conditions
- Pelvic organ prolapse1003861210029903
- Registration Number
- NL-OMON41517
- 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
Women with a primary apical and anterior 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 measured using the PISQ-12 questionnaire (if applicable),<br /><br>POP-Q, morbidity (including post-operative pain, complications and recovery of<br /><br>normal daily activities), disease specific and generic quality of life,<br /><br>repeated pelvic floor surgery within 36 months after intervention and cost<br /><br>analysis.</p><br>