Pivotal study data show efficacy of percutaneous SNM device for UUI

The Neuspera percutaneous sacral neuromodulation (pSNM) device demonstrated promising efficacy in the management of urge urinary incontinence (UUI), according to 6-month results from the pivotal phase 2 SANS UUI trial (NCT04232696).

Neuspera anticipates a regulatory decision on its premarket approval later this year.

The data will be presented at the 2025 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in Rancho Mirage, California, and were shared in a news release from Neuspera Medical.¹

The study included a total of 128 patients with UUI who were implanted with the battery-free pSNM device. Overall, 84.2% achieved a 50% or greater reduction in urgent leaks. According to Neuspera, these results are “on par with reported rates in recent SNM studies.”

Further, 84% of those who responded to treatment achieved a greater than 75% reduction in UUI symptoms, and 42% of responders achieved a 100% reduction in UUI symptoms. Data also showed a 3.5x clinically significant improvement in quality of life.

"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 presenting author Colin Goudelocke, MD, a urologist at Ochsner Health System, in the news release.¹ "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. I look forward to offering this option to my patients once it receives regulatory approval."

The prospective, single-arm SANS-UUI study enrolled adult patients with UUI who were screened and implanted with the device across 29 centers in the US and Europe. Patients included in the study had failed or were not a candidate for more conservative treatment or had failed or could not tolerate treatment with medication.²

Phase 1 of the SANS-UUI study assessed the utilization of the device and determined a length of hours for daily stimulation to be used in phase 2 of the trial. Data from phase 1 of the study were presented at the 2022 SUFU Winter Meeting and showed that among the 34 patients implanted with the device, 90% demonstrated at least a 50% improvement in UUI symptoms at 6- and 12-month follow-up with 2 hours of daily stimulation. Further, 52% of patients were completely dry at 12-month follow-up.³

The investigators concluded that 2 hours per day of stimulation led to statistically significant improvements in UUI in this patient population.⁴

Phase 2 of the study is further assessing the safety and efficacy of the system at the length of time determined in phase 1 of the study. The primary efficacy end point is the percentage of patients who experience at least a 50% change in UUI episodes from baseline to 6 months. The primary safety end point is the incidence of device-related serious adverse events at 6 months. Secondary end points include those outcomes at 12-month follow-up, in addition to other quality of life measures.

Final completion of the SANS-UUI trial is expected in December 2026.

Neuspera submitted its application for premarket approval to the FDA in September 2024. The company anticipates a decision later this year, it reported.

Stay tuned for a coming interview on these data with presenting author Colin Goudelocke, MD, of Ochsner Health System, on UrologyTimes.com!

References

1. Neuspera Medical announces landmark six-month clinical trial results for the first battery-free percutaneous sacral neuromodulation (pSNM) system for urgency urinary incontinence management. News release. Neuspera Medical Inc. February 26, 2025. Accessed February 28, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-announces-landmark-six-month-clinical-trial-results-for-the-first-battery-free-percutaneous-sacral-neuromodulation-psnm-system-for-urgency-urinary-incontinence-management-302385607.html

2.Neuspera’s implantable sacral nerve stimulation system in patients with symptoms of urinary urgency incontinence (UUI). ClinicalTrials.gov. Updated February 5, 2025. Accessed February 28, 2025. https://clinicaltrials.gov/study/NCT04232696

3. Neuspera Medical announces first successful implant of the Nuvella System in the second phase of its sans-UUI IDE Clinical Trial. News release. Neuspera Medical Inc. October 10, 2022. Accessed February 28, 2025. https://neuspera.com/neuspera-medical-announces-first-successful-implant-of-the-nuvella-system-in-the-second-phase-of-its-sans-uui-ide-clinical-trial/

4. Padron O, Hanson C, McCrery R, et al. Treatment of urinary urgency incontinence (UUI) with an ultra-miniaturized sacral nerve modulation (SNM) system: Outcomes of the SANS-UUI feasibility study. Presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2022 Winter Meeting; February 22-26, 2022; San Diego, California. Abstract 18. https://sufuorg.com/docs/meetings/sufu2202/abstracts.aspx