Multi-center, Prospective, Randomized, Controlled, Non-Inferiority, Clinical Trial of Chronic Afferent Nerve Stimulation (CAN-Stim) of the Tibial Nerve versus Sacral Nerve Stimulation (SNS) in the treatment of Urinary Urgency Incontinence resulting from Refractory Overactive Bladder (OAB) - “PROTECT” Study
Felicia Lane, MD
UCI Medical Center
To demonstrate the safety and efficacy of the Protect Chronic Afferent Nerve Stimulation (CAN-Stim) System in the treatment of urgency urinary incontinence resulting from refractory Over Active Bladder (OAB) syndrome
Adult females with a clinical diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence with predominate urge and a good candidate as determined by screening
9-10 visits over a 12 month follow up period with assessments at 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implant.
Potential benefits you may receive include the following: reduced number of urinary voids per day, reduced urgency to urinate, reduced number of urine leakage episodes, and improved quality of life. However, these potential benefits cannot be guaranteed. Information gained from your participation in the study may benefit future subjects with urgent urinary incontinence.
You will receive $250 for each study visit completed, up to $2250.
Linh Huynh, MPH, CRC