NCT02272361CompletedNot Applicable
Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up
University Hospital, Lille12 sites in 1 country220 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 12
- Primary Endpoint
- PFDI-20 score
Study Overview
Brief Summary
The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.
The secondary objectives of this study are the following:
- to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
- to overall quality of life assessment and expectations of patients.
- to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
- to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
- •Written informed consent
- •insured under the French social security system
Exclusion Criteria
- •Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
- •Participation in another trial
Arms & Interventions
laparoscopic sacrocolpopexy
Other
laparoscopic sacrocolpopexy
Intervention: laparoscopic sacrocolpopexy (Other)
vaginal mesh surgery
Other
vaginal mesh surgery
Intervention: vaginal mesh surgery (Other)
Outcomes
Primary Outcomes
PFDI-20 score
Time Frame: 4 years
The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (12)
Loading locations...
Similar Trials
Completed
Phase 3
Laparoscopic Assisted Versus Open Resection for Colorectal CarcinomaColorectal CarcinomaNCT00485316Chinese University of Hong Kong
Unknown
Not Applicable
Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse RepairPelvic Organ ProlapseNCT02852512University Of Perugia62
Unknown
Not Applicable
EndoCone Single Port Versus Conventional Multi-port Laparoscopic ApproachGallstonesNCT01709877Azienda Ospedaliero, Universitaria Pisana300
Recruiting
Phase 3
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid CancerColorectal CancerNCT02635503Cancer Institute and Hospital, Chinese Academy of Medical Sciences366
Completed
Not Applicable
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to StandEpithelial Ovarian CancerNCT01549925University of Utah50