The innovative battery-free percutaneous sacral neuromodulation (pSNM) device from Neuspera Medical has demonstrated significant efficacy in treating urge urinary incontinence (UUI), according to newly released 6-month data from the pivotal phase 2 SANS-UUI trial. The results, set to be presented at the 2025 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), mark a potential breakthrough in neuromodulation therapy.
Clinical Trial Results
In the multicenter study involving 128 patients, the pSNM device showed remarkable effectiveness, with 84.2% of participants achieving at least a 50% reduction in urgent leaks. The success rates align with outcomes reported in recent sacral neuromodulation (SNM) studies. More impressively, among those who responded to treatment, 84% experienced greater than 75% reduction in UUI symptoms, while 42% achieved complete symptom elimination. The study also documented a 3.5-fold improvement in patients' quality of life.
Study Design and Patient Population
The SANS-UUI trial, conducted across 29 centers in the US and Europe, enrolled adult patients who had either failed conservative treatments or were unsuitable candidates for medication-based approaches. The study implemented a prospective, single-arm design, building upon promising results from its phase 1 trial, which established that two hours of daily stimulation could lead to significant UUI improvement.
Expert Perspective
"These results demonstrate that Neuspera's pSNM technology provides similar effectiveness to traditional SNM devices while offering an alternative to a traditional implanted battery," said Dr. Colin Goudelocke, a urologist at Ochsner Health System and the study's presenting author. "Having options available for our patients is so crucial, and pSNM provides consistent relief from UUI while removing what can be an obstacle for some."
Regulatory Status and Future Outlook
Neuspera Medical submitted its premarket approval application to the FDA in September 2024, with a decision anticipated later this year. The SANS-UUI trial will continue monitoring patients through December 2026 to gather long-term efficacy and safety data. The primary safety endpoint focuses on device-related serious adverse events at 6 months, while secondary endpoints include 12-month outcomes and various quality of life measures.
