UH Urology Institute at the Forefront of Evidenced Based Solutions for Urinary Disorders
February 26, 2026
Innovations in Urology | Spring 2026
For the approximately 60 percent of women in the United States who report some degree of overactive bladder (OAB) and urinary incontinence (UI), the symptoms and disruptions can significantly impact the quality of life.1
Adonis Hijaz, MDFortunately, the physicians and researchers at the University Hospitals Urology Institute participate in critical studies to improve diagnosis and therapeutic options for these patients.
Neuromodulation Devices for Urinary Incontinence: RESTORE Study
“Revi is a commercially available neuromodulation device from BlueWind Medical for refractory OAB and was recently approved by the U.S. Food and Drug Administration,” says Adonis Hijaz, MD, Vice Chairman for Academics and Research, UH Urology Institute. “The Urology Institute is a clinical site for RESTORE, a manufacturer-led, post-market clinical trial to test ReviTM.”
The small Revi device is surgically implanted in the ankle under local anesthesia. After the surgical site heals, patients use a wearable device around their ankle for roughly 30 minutes every day. The device stimulates the posterior tibial nerve and sends signals up the leg to the brain to help manage symptoms.
Ellen Divoky, Manager of Clinical Research in the UH Urology Institute and project manager for this study, was instrumental in implementing and overseeing UH’s participation.
“RESTORE was a one-year, randomized, non-blind study to compare Revi therapy to non-active therapy for UI,” Divoky says. “All participants underwent surgical implantation of the device. Then they were randomly assigned to two groups. In one group, the device was immediately turned on; the other group waited four months and then their device was turned on.”
The FDA approved Revi for non-refractory urgency incontinence without the requirement that patients fail non-surgical therapies first, leaving it up to physicians to determine if and when to recommend the device. Ultimately, Dr. Hijaz says, what will largely dictate clinical practice are the guidelines third-party payers develop for approving its use.
Study Highlights
Expanded options for patient care. Although there are numerous treatments for urinary incontinence, Dr. Hijaz says he is encouraged by these new technologies. The FDA approved implantable tibial nerve stimulation devices in addition to Revi include eCoin by Valencia Technologies Corporation (2022) and recently approved Altaviva by Medtronics (2025).
“Revi, and other implantable devices, allows urologists to expand our armamentarium of options for treating patients who have urgency incontinence and overactive bladder,” he says. “ Medications are effective but can be associated with bothersome side effects and characterized by a high discontinuation rate negatively impacting their impact on symptom management. Implantable tibial nerve stimulation solutions represent an attractive option for patients compared to other advanced therapy options like sacral neuromodulation therapy or Botulinum toxin bladder injection.
Good outcomes. The OASIS pivotal trial for BlueWind Medical's Revi System showed excellent safety and sustained efficacy for overactive bladder (OAB) and urge urinary incontinence (UUI), with 79% of patients achieving ≥50% reduction in UUI episodes at 24 months, high patient satisfaction (97%), and no serious device/procedure-related adverse events.
Medtronic's TITAN II trial results support the FDA approval of their Altaviva™ system for urge urinary incontinence (UUI), showing significant effectiveness with over 60% of patients achieving a ≥50% reduction in leakage episodes and 70% experienced meaningful improvement in health-related quality of life.
The eCoin® Registration trial for the treatment of refractory urgency urinary incontinence revealed that 78% of subjects experienced at least a 50% reduction in UUI episodes at 2 years with 22% achieving complete dryness.
Patient involvement in care. “Patients who are empowered and engaged in their own healthcare do better than those essentially left alone to manage their problem,” says Dr. Hijaz. “They tend to pay attention to what they eat and drink and to know they are treating themselves for a good reason, which may play a role in reinforcing good habits and improved outcomes.”
Industry partnerships. UH develops, funds and implements many important research studies, and fostering positive relationships with manufacturers and participating in industry-sponsored trials is also a valuable way to expand the collective urology knowledge base.
“We both want the same result: better care for patients,” Dr. Hijaz says. “We are proud to be part of studies such as RESTORE. Furthermore, the insights we gain will help third party payers develop coverage guidelines.”
EMPOWER: Patient Engagement Improves Outcomes for Urinary Incontinence
Imagine struggling with symptoms of a medical problem for more than six years before seeking care from a physician, and then going another four years until you receive effective treatment. Unfortunately, this is a fact of life for many women who suffer from urinary incontinence (UI).
The UH Urology Institute is one of five institutions that participated in the EvidenceNow Initiative through Agency for Healthcare Research Quality (AHRQ) to address the gap in diagnosis and treatment of UI at the primary care level, where physicians are most able to address the problem. In general, physicians don’t screen for UI, leading to underreporting and undertreating of this common and disruptive condition. They coined the project the EMPOWER study, and have made this initiative a priority for the past four years. EMPOWER concluded in January 2026.
Of the 109 primary care providers in Northeast Ohio that are part of UH’s Primary Care Institute, 76 participated in EMPOWER.
“EMPOWER is intended to be a multimodal program to better diagnose women with UI, shorten the time between diagnosis and treatment and promote non-surgical treatments at the PCP or specialist level,” says Dr. Hijaz. “More than 15,000 women ages 18 and older were screened via the [International Consultation on Incontinence] questionnaire about urine leakage,” Dr. Hijaz says. “Of the 15,000 screened, 58 percent were experiencing UI, many with moderate to severe symptoms, confirming that UI is, in fact, a very common problem. Those who screened positive for UI were invited to join the 8-week trial, of which 400 did.”
Once enrolled in the study, participants were assigned to one of three arms: standard care, standard care plus a Nurse Navigator and the third arm added an interactive, artificial intelligence ChatBot called CeCe to help participants manage their symptoms. All participants received educational material and were asked to complete questionnaires. Some were selected for additional, optional interviews. PCPs also participated in Project ECHO, an expert facilitated telementoring program, to improve UI management on the provider end.
Outcomes. Preliminary results show that the presence and support of a Nurse Navigator reduced the severity of UI symptoms over six months compared to standard care, although the addition of the ChatBot made little difference.
“Our goal with EMPOWER was to remove barriers to diagnosing and managing UI in the primary care setting and to build capacity in physician offices for the management of UI,” Dr. Hijaz says. “As the name suggests, we strived to empower patients to talk to their providers about UI and engage them in self management. We also trained providers in the diagnosis and management of UI. This is a viable approach to an important – and undertreated – problem that affects millions of women. In fact, The EMPOWER Study team received commendations from Congresswoman Shontel Brown, 11th District, Ohio, in September 2023.”
Dr. Hijaz continues: “Key features of EMPOWER were the patient education component and direct interaction with a real person, the Patient Navigator. Our multipronged approach of patient, provider and systemwide involvement appears to be a sustainable approach to improving outcomes for women with urinary incontinence.”
For more information about the EMPOWER or RESTORE studies, call Ellen Divoky, Clinical Research Manager at 216-844-8092.
Contributing Expert:
Adonis Hijaz, MD
Vice Chairman, Academics and Research
University Hospitals Urology Institute
Director, Female Pelvic Surgery
University Hospitals Cleveland Medical Center
Lester Persky Professor of Urology
Case Western Reserve University School of Medicine
1Urinary Incontinence, StatPearls, 8/11/2024, Stephen W. Leslie, Linh, N, Tran, Yana, Puchett, https://www.ncbi.nlm.nih.gov.