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

Sponsor:	Carémeau Hospital
Information provided by:	Carémeau Hospital
ClinicalTrials.gov Identifier:	NCT00153231

Purpose

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	Intervention	Phase
Vaginal Prolapse	Device: IVS	Phase IV

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Anatomy Pelvic Support Problems Surgery

U.S. FDA Resources

Further study details as provided by Carémeau Hospital:

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

Estimated Enrollment:	80
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153231

Contacts

Contact: Renaud de Tayrac, MD

0033603263232

renaud.detayrac@chu-nimes.fr

Locations

France
Hôpital Carémeau	Recruiting
Nimes, France, 30000
Contact: Renaud de Tayrac, MD

Sponsors and Collaborators

Carémeau Hospital

Investigators

Principal Investigator:

Renaud de Tayrac, MD

Hôpital Carémeau, Nimes, France

More Information

No publications provided

Study ID Numbers:	SPIC
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00153231 History of Changes
Health Authority:	France: Ministry of Health

Additional relevant MeSH terms:

Genital Diseases, Female
Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Uterine Prolapse

Uterine Diseases
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on November 25, 2009