Willis Knighton Health Seeks Participants for Clinical Trials for Urinary Urge Incontinence Treatment

Jun 20, 2024

Willis Knighton Health is currently enrolling patients in the RESTORE Clinical Study to evaluate Revi, an FDA cleared device designed to reduce urinary urge incontinence symptoms. The study will demonstrate superiority of Revi System vs. non active therapy in treatment of UUI.  Willis Knighton is one of 18 sites nationwide chosen for the study. Gerard Henry, MD, is principal investigator.

Revi uses a miniature implant that is placed just above the ankle, near the tibial nerve- in an outpatient procedure under local anesthesia. You can walk out of the procedure the same day. The tibial nerve communicates with nerves in the lower back that control bladder function. Revi delivers electrical stimulation to the tibial nerve to help calm the bladder. The stimulation causes a mild tingling sensation and is personalized based on a patient’s response. Treatment sessions are conducted by the patient in the privacy and comfort of their own home.

To qualify, volunteers must be at least 18 years old with a history of urgency incontinence alone or in combination with urinary urgency for at least six months.  Study candidates will be asked to fill out questionnaires and complete a three-consecutive day voiding diary.

The duration of the study is 24 months, including follow-ups. Patients will be randomized in a 1:2 ratio into either the “control group” (delayed activation) or the “treatment group.” Both groups will be implanted with the system. “Treatment group” will start their treatment a month after the implantation.  The “control group” will start their treatment about four months after the treatment group.

If a patient qualifies and chooses to join the study, they will receive the Revi System Procedure and all study related care at no cost.  For information, contact Lakeya Randle, primary study coordinator with WK Clinical Research, at 318-212-8196 or visit ReviStudy.com to see if you qualify.