Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Phase 4

Completed

• Conditions: Vaginal Prolapse
• Interventions: Procedure: Sacrospinofixation; Device: IVS

• Registration Number: NCT00153231
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2005-12
• Study Completion: 2007-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

• Age more than 18
• Vaginal vault prolapse of grade 2 or more (POP-Q system)
• Symptomatic prolapse

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacrospinofixation	Sacrospinofixation	Intervention: Sacrospinofixation
Infracoccygeal sacropexy	IVS	Intervention: IVS

Primary Outcome Measures

Name	Time	Method
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.

Secondary Outcome Measures

Name	Time	Method
- Anatomical cure rate on vaginal vault support
- Peri-operative morbidity
- Patient satisfaction
- Quality of life
- Post-operative sexuality

Trial Locations

Locations (1)

Hôpital Carémeau; 🇫🇷 Nimes, France