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Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

NCT00153231 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-03-27

No results posted yet for this study

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.

Conditions

  • Vaginal Prolapse

Interventions

DEVICE

IVS

Infracoccygeal sacropexy

PROCEDURE

Sacrospinofixation

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Renaud de Tayrac, MD · Hôpital Carémeau, Nimes, France

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-12-31
Completion
2007-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153231 on ClinicalTrials.gov