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This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystocele repair with biomesh soft prolaps and endofast reliant | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of recurrence | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Correct positioning of the mesh as intended by the surgeon | day 1 |
| Procedural success | Technical success without complications till 30 days after the index-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic anterior prolapse
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| Name | Affiliation | Role |
|---|---|---|
| Koen Slabbaert, MD | RZ Heilig Hart Tienen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RZ Heilig Hart Tienen | Tienen | Vlaams-Brabant | 3300 | Belgium |
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| ID | Term |
|---|---|
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 30 days |
| Peroperative complications | Perforation bowels, bladder or arteries | day 1 |
| Postoperative complications | Infection, bleeding, recurrence, mesh erosion, pain during sexual activities, pain, discomfort | 3 years |
| Quality of life | PFDI-20, PFIQ-7, PISQ-12 | 3 years |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |