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New device aims to stop urgent bathroom trips

NCT ID NCT06217328

Symptom relief Sponsor: BlueWind Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the Revi System, a device that may help people with sudden, strong urges to urinate that cause leaking. About 150 adults who have had this problem for at least 6 months will either get the active device or an inactive version. The goal is to see if the active device reduces leaking episodes better than no treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

117 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed written informed consent. 2. 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. 3. Subject has been diagnosed with UUI for at least 6 months. 4. 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. 5. 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. 6. 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. 7. 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 Exclusion Criteria: 1. Subject participation in a clinical investigation with an active treatment arm within the past 90 days. 2. 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. 3. Subject with BMI \>50. 4. Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site. 5. Subject variation in diuretics consumption within the last 6 months. 6. Subject has received botulinum toxin injections for OAB within the past 12 months. 7. Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months. 8. Subject has had any spinal or genitourinary surgery within the last 6 months. 9. Subject had previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male). 10. Subject with diagnosis of BPH with outflow/obstructive predominant symptoms. 11. Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device. 12. Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder. 13. 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. 14. Subject with history of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e. peripheral neuropathy). 15. Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions. 16. 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. 17. 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. 18. Subject has a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene. 19. Subject has other active implantable electronic device/s regardless of whether stimulation is ON or OFF. 20. Subject has a life expectancy of less than 1 year.

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary urge incontinence

Contacts and locations

Locations

  • Adult and Pediatric Urology and Urogynecology

    Omaha, Nebraska, 68114, United States

  • Arizona Urology Specialists

    Tucson, Arizona, 85741, United States

  • Chesapeake Urology

    Owings Mills, Maryland, 21117, United States

  • DHR Health Institute for Research and Development

    Edinburg, Texas, 78539, United States

  • Duke Urogynecology - Duke University

    Durham, North Carolina, 27707, United States

  • Duly Health

    Lombard, Illinois, 60148, United States

  • Florida Urology Partners

    Tampa, Florida, 33615, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Pasadena Urology

    Pasadena, California, 91101, United States

  • Riverside Medical Clinic

    Riverside, California, 92506, United States

  • Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

    Sioux Falls, South Dakota, 57105, United States

  • Specialty Clinical Research of St. Louis, LLC

    St Louis, Missouri, 63141, United States

  • The Urology Place

    San Antonio, Texas, 78240, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Texas Southwestern - Department of Urology

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Urology Partners of North Texas

    Arlington, Texas, 76017, United States

  • Willis-Knighton Clinical Research

    Shreveport, Louisiana, 71103, United States

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