Vaginal Prolapse
Conditions
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.
Interventions
DEVICEIVS
Infracoccygeal sacropexy
PROCEDURESacrospinofixation
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early post-operative pain evaluated by a visual analogic pain the next day after the operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Peri-operative morbidity | — |
| - Patient satisfaction | — |
| - Quality of life | — |
| - Post-operative sexuality | — |
| - Anatomical cure rate on vaginal vault support | — |
Countries
France
Outcome results
None listed