Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
NCT ID: NCT00153231
Last Updated: 2015-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2003-03-31
2007-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Infracoccygeal sacropexy
Intervention: IVS
IVS
Infracoccygeal sacropexy
Sacrospinofixation
Intervention: Sacrospinofixation
Sacrospinofixation
Interventions
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IVS
Infracoccygeal sacropexy
Sacrospinofixation
Eligibility Criteria
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Inclusion Criteria
* Vaginal vault prolapse of grade 2 or more (POP-Q system)
* Symptomatic prolapse
Exclusion Criteria
* Cystocele without vaginal vault prolapse
* Vaginal vault prolapse of grade 1
* Associated rectal prolapse
* Rectal inflammatory disease (Crohn, RCH).
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Renaud de Tayrac, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Carémeau, Nimes, France
Locations
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Hôpital Carémeau
Nîmes, , France
Countries
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Other Identifiers
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SPIC
Identifier Type: -
Identifier Source: org_study_id
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