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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

September 8, 2005

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Vaginal Prolapse

Intervention ^ICMJE

Device: IVS

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Renaud de Tayrac, MD

0033603263232

renaud.detayrac@chu-nimes.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00153231

Responsible Party

Study ID Numbers ^ICMJE

SPIC

Study Sponsor ^ICMJE

Carémeau Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Renaud de Tayrac, MD

Hôpital Carémeau, Nimes, France

Information Provided By

Carémeau Hospital

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP