NCT06217328

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

A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: BlueWind Medical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Detailed description

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.

Conditions

• Urinary Urge Incontinence

Interventions

Type	Name	Description
DEVICE	Revi System Treatment	The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable
DEVICE	Revi System - Delayed Activation	The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable. The system will be implanted but it will not be turned on until 4 months post implant procedure.

Timeline

• Start date: 2024-02-24
• Primary completion: 2026-02-28
• Completion: 2027-02-28
• First posted: 2024-01-22
• Last updated: 2025-12-17

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study