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To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks |
|
| 2 | Placebo Comparator | Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal placebo device | Device | Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks | 8 weeks | |
| Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic investigation | 4 and 8 weeks | |
| Standardised Pad test | 4 and 8 weeks | |
| Number of severe urinary stress incontinence episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre européen d'explorations gynécologiques | Paris | 75005 | France |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| transvaginal electrical stimulation device | Device | Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks |
|
| 4 and 8 weeks |
| Number of sanitary napkins used | 4 and 8 weeks |
| Leakage index | 4 and 8 weeks |
| Subjective appreciation of patients | 4 and 8 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| 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 |