| Protocol Number: CI-10-0001 05/2010 - Present | |
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Eligibility Criteria for participation: · Males and Females, aged 18 through 75 years · Documented symptoms of idiopathic overactive bladder for at least 6 months · Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug · No urinary retention · No clinically significant bladder outlet obstruction · Not morbidly obese, defined as having BMI > 40 kg/m2 · No neurological disease effecting urinary bladder function, including but not limited to Parkinson’s disease, multiple sclerosis, stroke or spinal cord injury · No history of epilepsy · No pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months · No intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months · No Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 12 months · No presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the back Duration of Study All subjects will undergo treatment with the SNS patch for a total of 4 weeks (Weeks 1 through 4). |
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