Protocol Number: CI-10-0001 05/2010 - Present
 
 

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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