Urinary Urge Incontinence Clinical Trial
Official title:
A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes.
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
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 4-11 - Treatment optimization and follow up - Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation. - A call visit will be performed at 18-months. - 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: • 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 5-12 - Treatment optimization and follow up - Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation. - A call visit will be performed at 18-months. - 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. ;
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