SAVE U -trial: Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.
- Conditions
- - uterine descent, vaginal hysterectomy, sacrospinous fixation- descensus uteri, vaginale hysterectomie, sacrospinale fixatie
- Registration Number
- NL-OMON26877
- Lead Sponsor
- Isala Klinieken
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 208
Inclusion Criteria
POP-Q stage ≥ 2 uterine descent requiring surgery. Patients with co-existing anterior / posterior defects or concomitant incontinence surgery (TVT-O) can be included
too.
Exclusion Criteria
1. Previous pelvic floor or prolapse surgery;
2. Known malignancy or abnormal cervical smears;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical failure, defined as recurrence of prolapse POP-Q stage 2 of the middle compartment and prolapse complaints and/or redo surgery.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning.