Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Centre Hospitalier Universitaire de Nīmes49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Vaginal Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Secondary Outcomes

- Peri-operative morbidity

- Patient satisfaction

- Quality of life

- Post-operative sexuality

- Anatomical cure rate on vaginal vault support