Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
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|ClinicalTrials.gov Identifier: NCT00153231|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Prolapse||Device: IVS Procedure: Sacrospinofixation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||May 2007|
Experimental: Infracoccygeal sacropexy
Active Comparator: Sacrospinofixation
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153231
|Nimes, France, 30000|
|Principal Investigator:||Renaud de Tayrac, MD||Hôpital Carémeau, Nimes, France|