Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair - Tabular View

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Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

This study is currently recruiting participants.

Study NCT00153231. Last updated on September 8, 2005. Information provided by Carémeau Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

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.

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Vaginal Prolapse

Intervention ^†

Device: IVS

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

April 2003

Completion Date

December 2006

Eligibility Criteria ^†

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).

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Renaud de Tayrac, MD

0033603263232

renaud.detayrac@chu-nimes.fr

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00153231

Organization ID

SPIC

Secondary IDs ^††

Study Sponsor ^†

Carémeau Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Renaud de Tayrac, MD

Hôpital Carémeau, Nimes, France

Information Provided By

Carémeau Hospital

Verification Date

March 2003

First Received Date ^†

September 8, 2005

Last Updated Date

September 8, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.