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This is a pilot clinical study taking place at one site in Berlin, Germany using Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of 7 set treatment program with the device. After the 12 week treatment programme the subjects will be asked to perform daily set exercises for a further 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inko RS device | Experimental | 30 minutes of treatment with the Inko RS device, five days each week, for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inko RS Device | Device | 30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Based on a reduction in urine leakage following a standardised 1- min stress test at 1 hour post-bladder filing protocol (1-hour pad weight test) at 12 weeks compared to baseline following a 12 week treatment programme with the Inko RS Device. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate an improvement in quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL). | 4 wks, 8 wks and 12 weeks | |
| Evaluate an improvement in quality of life assessed using the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Hedwig Krankenhaus | Berlin | State of Berlin | 10115 | Germany |
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| at 4, 8 and 12 weeks |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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