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Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - rPMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rPMS device | Device | Pelvic floor muscle contractions will be induced by the device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of quality of life improvement using the ICIQ-UI questionnaire | Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement. | 18 months |
| Evaluation of quality of life improvement using the FSFI questionnaire | Evaluation of change in FSFI score. Increase of the score will be considered as an improvement. | 18 months |
| Evaluation of quality of life improvement using the PISQ-12 questionnaire | Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed. | Incidence of adverse events (AE) associated with study device will be followed. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julene Samuels | Louisville | Kentucky | 40205 | United States | ||
| Joseph Berenholz |
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| ID | Term |
|---|---|
| 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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| Farmington Hills |
| Michigan |
| 48334 |
| United States |
| Gynecological Solutions | Hillsborough | New Jersey | 08844 | United States |
| Southern Urogynecology | West Columbia | South Carolina | 29169 | United States |
| Hillcroft Medical Clinic | Sugar Land | Texas | 77479 | United States |
| 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 |