Evaluating the Revi System for treating urinary urge incontinence

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

This study is testing if the Revi System can help people with urinary urge incontinence feel better compared to waiting for treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: BlueWind Medical (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Birmingham, Alabama and 16 other locations)
• Trial ID: NCT06217328 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of the Revi System in treating urinary urge incontinence (UUI) through a randomized controlled design. Participants will be randomly assigned to receive either immediate activation of the Revi System or delayed activation after four months. The study aims to demonstrate the superiority of the Revi System therapy compared to non-active therapy. Data will be collected through various assessments, including voiding diaries and medical history evaluations, over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older who have been diagnosed with urinary urge incontinence for at least six months and experience frequent leaking episodes.

Not a fit: Patients who do not have urinary urge incontinence or those who are not compliant with follow-up evaluations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from urinary urge incontinence.

How similar studies have performed: Other studies have shown promise with similar device-based therapies for urinary incontinence, indicating potential for success with the Revi System.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent.
2. 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.
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.

Where this trial is running

Birmingham, Alabama and 16 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Arizona Urology Specialists — Tucson, Arizona, United States (Recruiting)
• Pasadena Urology — Pasadena, California, United States (Recruiting)
• Riverside Medical Clinic — Riverside, California, United States (Recruiting)
• Florida Urology Partners — Tampa, Florida, United States (Recruiting)
• Willis-Knighton Clinical Research — Shreveport, Louisiana, United States (Recruiting)
• Chesapeake Urology — Owings Mills, Maryland, United States (Recruiting)
• Specialty Clinical Research of St. Louis, LLC — Saint Louis, Missouri, United States (Recruiting)
• Adult and Pediatric Urology and Urogynecology — Omaha, Nebraska, United States (Recruiting)
• Montefiore Medical Center — Bronx, New York, United States (Recruiting)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
• Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic — Sioux Falls, South Dakota, United States (Recruiting)
• Urology Partners of North Texas — Arlington, Texas, United States (Recruiting)
• University of Texas Southwestern - Department of Urology — Dallas, Texas, United States (Recruiting)
• DHR Health Institute for Research and Development — Edinburg, Texas, United States (Recruiting)
• The Urology Place — San Antonio, Texas, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Roni Diaz, VP, Clinical & Regulatory Affairs

Conditions Urinary Urge Incontinence