Trial progresses of SNM device for urge urinary incontinence

All patients have completed the 6-month primary end point visit in phase 2 of the SANS-UUI trial (NCT04232696), which is evaluating the safety and efficacy of the Neuspera Implantable Sacral Neuromodulation (SNM) System in patients with urge urinary incontinence (UUI) associated with overactive bladder (OAB), announced Neuspera, the developer of the device, in a news release.¹

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

"Reaching the final patient's primary end point visit for the clinical trial is an important milestone in Neuspera's journey towards revolutionizing the way physicians utilize SNM therapy," said Steven Siegel, MD, chief medical officer of Neuspera Medical, in the news release.¹ "This will be a great solution for patients who want a high degree of symptom control with the smallest implantable neurostimulator available, designed to empower patients and provide ultimate discreetness, putting control of life-altering symptoms in patients' hands."

The prospective, single-arm SANS-UUI study enrolled adult patients with UUI who were screened and implanted with the device across 26 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 a medical meeting in 2022 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 from baseline in UUI episodes at 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.

According to Neuspera, data from phase 2 of the SANS-UUI trial are expected to support an application to the FDA for approval of the device in patients with OAB-related UUI. Currently, the Neuspera System is cleared for the treatment of patients with chronic pain of peripheral nerve origin.

"As the coordinating investigator for the SANS-UUI clinical trial, based on my experience with the Neuspera System and how patients are responding, I'm excited to soon be able to offer an OAB treatment option that truly gives patients control of their bladders in the least invasive way with the ability to self-administer their therapy when it's convenient for them, and nobody else can see or feel it," said Osvaldo F. Padron, MD, in the news release.¹ Padron is a urologist at Florida Urology Partners in Tampa, Florida.

Final completion of the SANS-UUI trial is expected in December 2026.²

References

1. Neuspera Medical, Inc. reaches significant milestone: Final patient has completed primary endpoint visit in the SANS-UUI pivotal clinical trial. News release. Neuspera Medical, Inc. Published online and accessed July 23, 2024. https://www.prnewswire.com/news-releases/neuspera-medical-inc-reaches-significant-milestone-final-patient-has-completed-primary-endpoint-visit-in-the-sans-uui-pivotal-clinical-trial-302203425.html

2.Neuspera’s implantable sacral nerve stimulation system in patients with symptoms of urinary urgency incontinence (UUI). ClinicalTrials.gov. Last updated May 25, 2023. Accessed July 23, 2024. 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 July 23, 2024. 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, and Urogenital Reconstruction 2022 Winter Meeting. February 22-26, 2022. San Diego, California. Abstract 18. https://sufuorg.com/docs/meetings/sufu2202/abstracts.aspx