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underenrollment
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The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial Nerve | Active Comparator | Transcutaneous electrical stimulation will be placed on the posterior tibial nerve. |
|
| Parasacral | Active Comparator | Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina. |
|
| Shoulder | Sham Comparator | Transcutaneous electrical stimulation will be placed on the shoulder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of incontinence episodes per day | Patients will self-report the number of incontinence episodes. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bladder voids per day | Patients will self-report the number of times they void their bladder. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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 |
| D001745 | Urinary Bladder Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |