Sacrospinous ligament fixation or Elevate Posterior procedure in treatment of primary apical prolapse stage * 2: a matched cohort study.
Withdrawn
- Conditions
- Pelvic Organ prolapse10029903
- Registration Number
- NL-OMON39017
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 105
Inclusion Criteria
Women with a primary apical compartment prolapse stage * 2 requiring surgery. Patients with co-existing posterior defects or concomitant perineal surgery (perineoplasty) can be included.
Exclusion Criteria
- Previous prolapse surgery
- Women of reproductive age desiring future pregnancy and childbirth
- Unwilling to return for follow-up or language barriers
- Co-morbidity that is associated with increased surgical risks, for instance women with ASA 3 or 4 classification. Up to the physician to decide.
- Poor cognitive function, as subjectively assessed by the physician.
- History of or current major psychiatric illness as subjectively assessed by the physician.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Quality of life related to pelvic floor function after 12 months measured using<br /><br>validated 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>