Shreveport, LA (June 24, 2024) – Willis-Knighton Health is actively recruiting participants for the RESTORE Clinical Study, aimed at evaluating the effectiveness of the Revi system, an FDA-cleared device designed to alleviate symptoms of urinary urge incontinence (UUI). This study, which includes Willis-Knighton as one of only 18 sites nationwide, seeks to demonstrate the superiority of the Revi System over non-active therapies. The study is led by principal investigator Dr. Gerard Henry.
The Revi device employs a miniature implant placed just above the ankle near the tibial nerve in an outpatient procedure under local anesthesia. This minimally invasive procedure allows patients to walk out the same day. The tibial nerve connects to nerves in the lower back that control bladder function, and Revi delivers electrical stimulation to the tibial nerve to help calm the bladder. The stimulation, which causes a mild tingling sensation, is tailored to each patient’s response. Notably, patients can conduct their treatment sessions in the comfort and privacy of their own homes.
To qualify for the study, volunteers must be at least 18 years old and have experienced urgency incontinence alone or in combination with urinary urgency for at least six months. Study candidates will need to fill out questionnaires and maintain a three-day consecutive voiding diary.
The study duration is 24 months, including follow-up periods. Participants will be randomized in a 1:2 ratio into either a “control group” (delayed activation) or a “treatment group.” Both groups will be implanted with the Revi system, but the “treatment group” will commence their treatment one month post-implantation, while the “control group” will begin approximately four months after the treatment group.
Participants who qualify and choose to join the study will receive the Revi system procedure and all related care at no cost. Those interested in participating can contact Lakeya Randle, the primary study coordinator at WK Clinical Research, at 318-212-8196, or visit ReviStudy.com to determine eligibility.
About Willis-Knighton Health:
Willis-Knighton Health is dedicated to advancing medical treatments and improving patient outcomes through innovative research and clinical trials. Their participation in the RESTORE Clinical Study underscores their commitment to providing cutting-edge care to patients suffering from urinary urge incontinence.
For more information, interviews, or media inquiries, please contact Lakeya Randle at 318-212-8196.