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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infracoccygeal sacropexy | Experimental | Intervention: IVS |
|
| Sacrospinofixation | Active Comparator | Intervention: Sacrospinofixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVS | Device | Infracoccygeal sacropexy |
| |
| Sacrospinofixation |
| Measure | Description | Time Frame |
|---|---|---|
| Early post-operative pain evaluated by a visual analogic pain the next day after the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| - Peri-operative morbidity | ||
| - Patient satisfaction | ||
| - Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD | Hôpital Carémeau, Nimes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Carémeau | Nîmes | 30000 | France |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Procedure |
|
| - Post-operative sexuality |
| - Anatomical cure rate on vaginal vault support |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |