Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01705-40 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):
A. The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UGYTEX | Experimental | Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) |
|
| No MESH | Active Comparator | Patients in this arm had subvesical plication without reinforcement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UGYTEX | Device | Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional failure | The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical failure | The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years. | 5-8 years |
| Post-operative complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Champeau | Béziers | 34500 | France | |||
| APHP - Hôpital Antoine Beclere |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31506808 | Result | Allegre L, Callewaert G, Alonso S, Cornille A, Fernandez H, Eglin G, de Tayrac R. Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse. Int Urogynecol J. 2020 Apr;31(4):745-753. doi: 10.1007/s00192-019-04073-x. Epub 2019 Sep 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No mesh. | Procedure | Patients in this arm had subvesical plication without reinforcement. |
|
Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh. |
| 5-8 years |
| The PGI-I questionnaire | 5-8 years |
| The PFDI questionnaire | 5-8 years |
| The PFIQ questionnaire | 5-8 years |
| The PISQ-12 questionnaire | 5-8 years |
| Clamart |
| 92141 |
| France |
| CHU de Clermont Ferrand - Hôpital Estaing | Clermont-Ferrand | 63003 | France |
| APHP - Hôpital Beaujon | Clichy | 92110 | France |
| CH d'Issoire - Centre Hospitalier Paul Ardier | Issoire | 63503 | France |
| CH de la Rochelle | La Rochelle | 17019 | France |
| CH de Chartres - Hôpital Louis Pasteur | Le Coudray | 28630 | France |
| APHP - Centre Hospitalier Universitaire de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CH d'Orange - Hôpital Louis Giorgi | Orange | 84106 | France |
| Clinique Mutualiste La Sagesse | Rennes | 35000 | France |
| CHU de Rouen - Hôpital Charles Nicolle | Rouen | 76031 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |