Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT02998216
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- age 18 and above
- pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
- signed informed consent
Exclusion Criteria
- gynecologic surgery in the three past months before planned surgery
- history of prolapse surgery
- participation in another study
- need to simultaneously perform other surgical procedures (i.e. rectopexy)
- ongoing chemotherapy of treatment with immunosuppressant drugs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pelvic floor symptoms Twelve months Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
- Secondary Outcome Measures
Name Time Method Anatomical outcome / Prolapse stage after surgery Twelve months Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)
Changes in quality of life Twelve months Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Changes in sexual activity Twelve months Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Trial Locations
- Locations (1)
University Hospital Tuebingen
🇩🇪Tubingen, Baden-Wuerttemberg, Germany