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.
1 other identifier
interventional
150
1 country
19
Brief Summary
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
February 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedDecember 17, 2025
December 1, 2025
2 years
January 3, 2024
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Endpoint
Superiority of active Revi therapy over non-active therapy in the treatment of subjects with urinary urge incontinence based on a 3-day voiding diary
Month 4
Study Arms (2)
Device: Revi System Treatment Arm
OTHERSubjects 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.
Device: Revi System - Delayed Activation Control Arm
OTHERSubjects 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.
Interventions
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.
The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable
Eligibility Criteria
You may qualify if:
- Signed written informed consent.
- Subject is at least 21 years old, with no plans to become pregnant during the trial. If of child bearing potential and sexually active, negative pregnancy test and using acceptable contraception.
- Subject has been diagnosed with UUI for at least 6 months.
- Subject experiences a minimum of four (4) leaking episodes associated with urgency, with at least one episode per day for 2 days documented on a voiding diary for 3 consecutive days.
- If used, subject should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 1 month prior to baseline and agree to remain on stable medication consumption until the 24-month follow-up visit.
- If used, subject should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior to baseline.
- Subject agrees to attend all follow-up evaluations and is willing and capable to completely and accurately fill out voiding diaries and questionnaires and is willing to complete required exams and test
You may not qualify if:
- Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
- Subject is a high surgical risk with multiple illnesses or active general infections that expose them to excessive bleeding or delayed or non-healing wounds. This includes patients who need anticoagulation therapy that cannot be temporarily stopped for the implantation procedure.
- Subject with BMI \>50.
- Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
- Subject variation in diuretics consumption within the last 6 months.
- Subject has received botulinum toxin injections for OAB within the past 12 months.
- Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
- Subject has had any spinal or genitourinary surgery within the last 6 months.
- Subject had previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
- Subject with diagnosis of BPH with outflow/obstructive predominant symptoms.
- Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
- Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder.
- Subject has recurrent urinary tract infections (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone.
- Subject with history of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e. peripheral neuropathy).
- Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BlueWind Medicallead
Study Sites (19)
Arizona Urology Specialists
Tucson, Arizona, 85741, United States
Pasadena Urology
Pasadena, California, 91101, United States
Riverside Medical Clinic
Riverside, California, 92506, United States
Florida Urology Partners
Tampa, Florida, 33615, United States
University of Chicago
Chicago, Illinois, 60637, United States
Duly Health
Lombard, Illinois, 60148, United States
Willis-Knighton Clinical Research
Shreveport, Louisiana, 71103, United States
Chesapeake Urology
Owings Mills, Maryland, 21117, United States
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri, 63141, United States
Adult and Pediatric Urology and Urogynecology
Omaha, Nebraska, 68114, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke Urogynecology - Duke University
Durham, North Carolina, 27707, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105, United States
Urology Partners of North Texas
Arlington, Texas, 76017, United States
University of Texas Southwestern - Department of Urology
Dallas, Texas, 75390, United States
DHR Health Institute for Research and Development
Edinburg, Texas, 78539, United States
The Urology Place
San Antonio, Texas, 78240, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lori Fein
BlueWind Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2024
First Posted
January 22, 2024
Study Start
February 24, 2024
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share