RESTORE: An RCT to Evaluate the Efficacy of the Revi System

Prospective, multi-center, open label, post market, randomized controlled trial To demonstrate superiority of Revi System therapy vs. non active therapy in the treatment of UUI Treatment Arm: Device: Revi System Subjects will be implanted with a Revi System and activation of therapy will occur \~4 weeks post implantation and continue for the duration of the study. Control Arm: Device: Revi System - Delayed Activation Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study. Randomization in a 1:2 ratio into either the "control group" or the "treatment group" will be performed in blocks of 3 or 6 randomly, across the study population by a central randomization system. Randomization will be stratified by investigational site. The study will consist of the following activities: Visit 1 - Screening * Potential subjects with UUI, who fulfil basic criteria will be informed of the study and will be invited to sign an informed consent form. * Demographic information (age, race, height and weight, leg circumference), medical and surgical history and concomitant medication information will be collected. * Study candidates will be asked to fill out various questionnaires * Patients will be asked to complete a 3- consecutive day voiding diary. * Urine sample will be collected, blood will be drawn and a full physical examination, including a PVR measurement and uroflow (in men), will be performed. Visit 2 - Randomization \& Implantation * 5 ± 4 weeks after starting the diary, eligible subjects will be randomized to either the Treatment or Control (delayed activation) arms (2:1) and will undergo unilateral implantation with the BlueWind Revi System * Collection of AE and concomitant medication will be performed Treatment Arm: Visit 3 - Activation * After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. * Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system. Visits 4-9 - Treatment optimization and follow up * Follow-up visits will be performed at 1, 2, 3, 6, 9, and 12 months post system activation. * All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit. * During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed. Control Arm: Visit 3 - Post-operative check-up • After a recovery period of 1-month post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. Visit 4 - Activation * After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. * Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system. Visits 5-10 - Treatment optimization and follow up * Follow-up visits will be performed at 1, 2, 3, 6, 9, and 12 months post system activation. * All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit. * During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed.