Summary:
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence and urinary urgency frequency in those patients who have tried and failed two or more conservative therapies. The device, weighing less than 0.03 ounces and measuring 1.0” x 0.1”, stimulates a nerve located in the pelvic region, called the pudendal nerve. Stimulation of this nerve is intended to reduce urinary urge and unwanted urination.
Qualified Participants Must:
• Be age 18 years or older
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Be diagnosed with urinary urge incontinence or urgency frequency syndrome
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Not be pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 month period
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Not be currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function