Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.
Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.|
- Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
- - Peri-operative morbidity
- - Patient satisfaction
- - Quality of life
- - Post-operative sexuality
- - Anatomical cure rate on vaginal vault support
|Study Start Date:||March 2003|
|Study Completion Date:||May 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: Infracoccygeal sacropexy
Active Comparator: Sacrospinofixation
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153231
|Nimes, France, 30000|
|Principal Investigator:||Renaud de Tayrac, MD||Hôpital Carémeau, Nimes, France|