Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
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.
1 other identifier
interventional
49
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 27, 2015
March 1, 2015
2.8 years
September 8, 2005
March 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
Secondary Outcomes (5)
- Peri-operative morbidity
- Patient satisfaction
- Quality of life
- Post-operative sexuality
- Anatomical cure rate on vaginal vault support
Study Arms (2)
Infracoccygeal sacropexy
EXPERIMENTALIntervention: IVS
Sacrospinofixation
ACTIVE COMPARATORIntervention: Sacrospinofixation
Interventions
Eligibility Criteria
You may qualify if:
- Age more than 18
- Vaginal vault prolapse of grade 2 or more (POP-Q system)
- Symptomatic prolapse
You may not qualify if:
- Patient unable to read French language
- Cystocele without vaginal vault prolapse
- Vaginal vault prolapse of grade 1
- Associated rectal prolapse
- Rectal inflammatory disease (Crohn, RCH).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Carémeau
Nîmes, 30000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renaud de Tayrac, MD
Hôpital Carémeau, Nimes, France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
March 1, 2003
Primary Completion
December 1, 2005
Study Completion
May 1, 2007
Last Updated
March 27, 2015
Record last verified: 2015-03