Urinary Urge IncontinenceNCT06217328
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
A study testing Revi System Treatment and Revi System - Delayed Activation in people with Urinary Urge Incontinence, run by BlueWind Medical at 19 sites in United States.
Trial summary
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Urge Incontinence
- What is being tested?
- Revi System Treatment and Revi System - Delayed Activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 19 sitesUnited States
- Study dates
- 24 Feb 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Subject is at least 18 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
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Subject has open wounds or sores on the lower leg or foot or had previous, unhealed trauma in the implant area or has pitting edema (≥2+) in the lower leg.
- Subject has Venous or Arterial disease/insufficiency in the lower leg or Vasculitis or dermatologic condition in the lower leg or infections near the implantation site in the lower leg.
- Subject has a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene.
- Subject has other active implantable electronic device/s regardless of whether stimulation is ON or OFF.
- Subject has a life expectancy of less than 1 year.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Urology Partners of North Texas
Arlington, Texas, 76017
University of Chicago
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Texas Southwestern - Department of Urology
Dallas, Texas, 75390
Duke Urogynecology - Duke University
Durham, North Carolina, 27707
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Duly Health
Lombard, Illinois, 60148
Adult and Pediatric Urology and Urogynecology
Omaha, Nebraska, 68114
Chesapeake Urology
Owings Mills, Maryland, 21117
Pasadena Urology
Pasadena, California, 91101
Riverside Medical Clinic
Riverside, California, 92506
University of Utah
Salt Lake City, Utah, 84112
The Urology Place
San Antonio, Texas, 78240
Willis-Knighton Clinical Research
Shreveport, Louisiana, 71103
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri, 63141
Florida Urology Partners
Tampa, Florida, 33615
Montefiore Medical Center
The Bronx, New York, 10461
Arizona Urology Specialists
Tucson, Arizona, 85741
About this study
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.
Read the 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 4-9 - 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.
- Conditions
- Urinary Urge Incontinence
- Being tested
- Revi System Treatment, Revi System - Delayed Activation
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revi System TreatmentDevice
The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable
Revi System - Delayed ActivationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device: Revi System Treatment Arm | Other | 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. Receives: Device: Revi System Treatment |
| Device: Revi System - Delayed Activation Control Arm | Other | 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. Receives: Device: Revi System - Delayed Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start24 Feb 2024
- Primary completion28 Feb 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will be implanted with the device and randomized (2:1) to ON vs OFF. After the subjects complete the OFF period, their system will be activated and they will crossover to the ON group.
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Fein, Study director, BlueWind Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217328
- Sponsor's protocol ID
- G02-CLP-0019
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06217328
- Acronym / sponsor ID
- G02-CLP-0019
- Conditions
- Urinary Urge Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 117 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 4-9 - 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects will be implanted with the device and randomized (2:1) to ON vs OFF. After the subjects complete the OFF period, their system will be activated and they will crossover to the ON group.
| Arm | Type | Receives |
|---|---|---|
| Device: Revi System Treatment Arm | Other | Device: Revi System TreatmentSubjects 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 | Other | Device: Revi System - Delayed ActivationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent.
- Subject is at least 18 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revi System TreatmentThe Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable | Device | Device: Revi System Treatment Arm |
| Revi System - Delayed ActivationThe 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. | Device | Device: Revi System - Delayed Activation Control Arm |
Primary outcome
Primary Endpoint
Time frame: Month 4
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Fein study director
BlueWind Medical
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revi System Treatment and Revi System - Delayed Activation in people with Urinary Urge Incontinence, run by BlueWind Medical at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.