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The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Experimental | Treatment using electrical field stimulation of peripheral nerves |
|
| Sham Device | Sham Comparator | Control group using sham device to mimic sound and sensation of investigational device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Field Stimulation Device | Device | Treatment with Electrical Field Stimulation Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm | Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham | One week after final treatment visit |
| No Serious Adverse Events or Unanticipated Adverse Device Effects | Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up | First treatment through follow-up (one week after last treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Birmingham Urologic Associates | Principal Investigator |
| Scott MacDiarmid, MD | Alliance Urology Specialists | Principal Investigator |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Sham Nerve Stimulation Device | Device | Use of the sham device |
|
| 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 |