Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT00153231

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Prolapse	Device: IVS Procedure: Sacrospinofixation	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

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 :

Mar 1, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infracoccygeal sacropexy Intervention: IVS	Device: IVS Infracoccygeal sacropexy
Active Comparator: Sacrospinofixation Intervention: Sacrospinofixation	Procedure: Sacrospinofixation

Arm

Intervention/Treatment

Experimental: Infracoccygeal sacropexy

Intervention: IVS

Device: IVS

Infracoccygeal sacropexy

Active Comparator: Sacrospinofixation

Intervention: Sacrospinofixation

Procedure: Sacrospinofixation

Outcome Measures

Primary Outcome Measures

Early post-operative pain evaluated by a visual analogic pain the next day after the operation. []

Secondary Outcome Measures

- Peri-operative morbidity []
- Patient satisfaction []
- Quality of life []
- Post-operative sexuality []
- Anatomical cure rate on vaginal vault support []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Carémeau	Nimes		France	30000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Renaud de Tayrac, MD, Hôpital Carémeau, Nimes, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT00153231

Other Study ID Numbers:

SPIC

First Posted:

Sep 12, 2005

Last Update Posted:

Mar 27, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Uterine Prolapse

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Mar 27, 2015