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This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - rPMS |
|
| Control Group | Active Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rPMS device | Device | Pelvic floor muscle contractions will be induced by the rPMS device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of quality of life improvement using the UDI-6 questionnaire | Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement. | 13 months |
| Evaluation of incontinence episodes using Bladder diary | Evaluation of change in incontinence episodes before and after the study treatment in both study groups. | 13 months |
| Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire | Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement. | 13 months |
| Evaluation of quality of life improvement using the Pad Usage Questionnaire | Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement. | 13 months |
| Evaluation of pelvic floor muscle strength | Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction evaluation | Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment. | 13 months |
| Therapy comfort evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Urogyn | Wellesley | Massachusetts | 02481 | United States | ||
| Center for Urogynecology and Reconstructive Surgery |
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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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| Pelvic floor muscle training | Procedure | Control group will undergo a pelvic floor muscle training |
|
Evaluation of therapy comfort after each treatment or training session using the questionnaire.
| 1 month |
| Safety evaluation | Incidence of adverse events (AE) associated with study device will be followed. | 13 months |
| Somerset |
| New Jersey |
| 08873 |
| United States |
| The Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | United States |
| The Female Pelvic Medicine Institute | Richmond | Virginia | 23225 | 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 |