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| Name | Class |
|---|---|
| Hospital de Granollers | OTHER |
| Hospital Quiron Sagrado Corazon | OTHER |
| Hospital de Mataró | OTHER |
| Hospital Riotinto |
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This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVDF transobturator tape | Active Comparator | Transobturator tension-free suburethral tape made of polyvinylidene fluoride. |
|
| PP transobturator tape | Active Comparator | Transobturator tension-free suburethral tape made of polypropylene. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVDF transobturator tape | Device |
|
| |
| Polypropylene transobturator tape |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria:
| One year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Comparison of the intra- and postoperative complications between both procedures. | Up to one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective questionnaires of incontinence severity | Change in the punctuation of the following questionnaires comparing before surgery and one year after operation:
| One year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Barcelona | Spain | ||||
| Hospital de Viladecans |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| UNKNOWN |
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
| Hospital de Viladecans | OTHER |
| Hospital Santa Caterina | UNKNOWN |
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| Device |
|
| Barcelona |
| Spain |
| Hospital General de Granollers | Barcelona | Spain |
| Hospital Universitari de Bellvitge | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Santa Caterina | Girona | Spain |
| Hospital General Riotinto | Huelva | Spain |
| Hospital Quiron Sagrado Corazon | Seville | Spain |
| Hospital Virgen del Rocío | Seville | Spain |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |