Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Vaginal Prolapse Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153231
• Other study ID #: SPIC
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: March 26, 2015
• Start date: March 2003
• Est. completion date: May 2007

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Prolapse

Intervention

Device:
• IVS
Infracoccygeal sacropexy

Procedure:
• Sacrospinofixation

Locations

Country	Name	City	State
France	Hôpital Carémeau	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early post-operative pain evaluated by a visual analogic pain the next day after the operation.			Yes
Secondary	- Peri-operative morbidity			Yes
Secondary	- Patient satisfaction			No
Secondary	- Quality of life			No
Secondary	- Post-operative sexuality			No
Secondary	- Anatomical cure rate on vaginal vault support			No