Evaluation of two vaginal surgical procedures for the treatment of pelvic organ prolapse: unilateral (direct) and bilateral (indirect) sacrospinous ligament fixation.
Recruiting
- Conditions
- pelvic organ prolapse, prolapse, uterine prolapse, vaginal vault prolapse
- Registration Number
- NL-OMON22473
- Lead Sponsor
- Academic Medical Center (AMC), Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
Inclusion Criteria
1. Subject is female;
2. Subject is least 18 years of age;
Exclusion Criteria
1. Subjects who are pregnant or want to become pregnant;
2. Subjects who are not capable of giving informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Surgical success in the treatment of apical prolapse: The primary outcome measure will be surgical success” or failure” assessed one year after surgery. The primary outcome measure has three components:<br /><br>- An anatomic assessment of prolapse, using the POPQ examination<br /><br>- The presence or absence of bulge symptoms specific to prolapse, using two questions from the PFDI-20 questionnaire;<br /><br>- An assessment of additional treatment (surgical or non-surgical) for prolapse after the index surgery.<br /><br>2. Improvement of quality of life related to pelvic floor function: PFDI-20 questionnaire.<br>
- Secondary Outcome Measures
Name Time Method - Morbidity<br /><br>- Quality of life related to pelvic floor function, stratified by compartment<br /><br>- Sexual satisfaction improvement from baseline<br /><br>- Superiority of BSC-mesh in the treatment of apical prolapse<br /><br>- Procedure related serious adverse events