PRAGUE, March 21, 2023 /PRNewswire/ -- STIMVIA a pioneer medical technology company focused on the development and commercialization of novel non-invasive neuromodulation for the treatment of lower urinary tract and bowel dysfunction, announces the publication of the safety and efficacy results of peroneal electrical Transcutaneous NeuroModulation (Peroneal eTNM®) delivered by URIS® neuromodulation system in patients with overactive bladder (OAB). The peer-reviewed publication is currently available online and the print article is scheduled to be published in the April issue of an official journal of the American Urological Association, The Journal of Urology.
URIS® is a breakthrough technology for the treatment of diseases associated with Central Nervous System disorders.
The URIS® trial was an international, prospective, randomized, an active comparator-controlled, multicenter trial evaluating the safety and efficacy of peroneal eTNM® using URIS® neuromodulation system versus solifenacin in patients with OAB symptoms, including frequent urination, sudden urge to urinate, and/or urge incontinence. A total of 77 patients were randomized in a 2:1 ratio into one of two groups for a 12-week treatment period with a four-week safety follow-up period: URIS® neuromodulation system was administered once daily for 30 minutes, while Solifenacin 5 mg was administered orally once daily.
In the trial, URIS® neuromodulation system demonstrated consistent efficacy, was well tolerated and showed a significantly better safety profile over solifenacin.
"The results of this study demonstrate that peroneal eTNM® using the URIS® neuromodulation system is safe, well tolerated, and effective, with over 85% of patients experiencing clinically significant improvement in most bothersome OAB symptoms. Importantly, peroneal eTNM® is associated with significantly lower incidence of treatment-related adverse events compared to solifenacin," says Prof. Jan Krhut, a key investigator in the URIS® trial, a Professor of Urology at University of Ostrava and adds: "The results of this clinical trial have demonstrated that URIS® neuromodulation system could provide an important new non-invasive modality to oral treatment for patients suffering with OAB."
"Over hundreds of millions worldwide suffer from OAB symptoms, and more than 80% of patients cannot find relief due to side effects or low effectiveness of oral pharmacotherapy. URIS® neuromodulation system is safe and effective for overactive bladder treatment associated with a considerably better benefit-risk profile over oral pharmacotherapy and significantly positive impact on patient´s Quality of Life," says Dr. Roman V. Dvorak, Chief Medical Officer of Stimvia.