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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01201-52 | Other Identifier | ANSM |
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withdrawal of vaginal prosthesis from the market
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The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic promontofixation | Active Comparator |
| |
| Anterior vaginal sacrospinofixation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| promontofixation | Procedure | reconstruction of cystoceles using a subvesical prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response | ≥ 2 to question 17 of PFDI-20 questionnaire | 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| De novo dyspareunia rate the dyspareunia between groups | ≥ 2 to question 11 of the PISQ-IR questionnaire. | 12 months after the initial intervention |
| Quality of sexual life between groups | PISQ-IR questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de clermont-Ferrand | Clermont-Ferrand | 63003 | France | |||
| CHU de Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35044477 | Result | de Tayrac R, Cosson M, Panel L, Compan C, Zemmache MZ, Bouvet S, Wagner L, Fatton B, Lamblin G. Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial. Int Urogynecol J. 2022 Jul;33(7):2021-2030. doi: 10.1007/s00192-021-05071-8. Epub 2022 Jan 19. |
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| sacrospinofixation | Procedure | Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route |
|
| 12 months after the initial intervention |
| Re-intervention for suburethral band (BSU) in de novo SUI between groups | binary: yes/no. | up to 12 months after the initial intervention |
| Compare anatomical prolapse symptoms between groups | POP-Q questionnaire | at 6 weeks and 12 months after intervention |
| Compare functional prolapse symptoms between groups | PFDI-20 questionnaire | at 6 weeks and 12 months after intervention |
| Compare quality of life associated to pelvic floor issues between groups | PFIQ questionnaire | at 6 weeks and 12 months after intervention |
| Compare general quality of life between groups | SF12 questionnaire | at 6 weeks and 12 months after intervention |
| Compare global satisfaction between groups | PGI-I questionnaire | at 6 weeks and 12 months after intervention |
| Compare perioperational morbidity between groups | complication assessed as stage ≥2 on Clavien-Dindo classification, or according to the ICS/IUGA classification. | at 6 weeks and 12 months after intervention |
| Compare direct and indirect costs of the 2 interventions | 12 months after intervention |
| Lille |
| 59037 |
| France |
| HFME - Hospices Civils de Lyon | Lyon | 69677 | France |
| Clinique Beau-Soleil | Montpellier | 34070 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU Nimes | Nîmes | 30029 | France |