Phase 2 study of SNM device for UUI meets enrollment goal
According to Neuspera, results from phase 2 of the SANS-UUI trial are expected to support an application for FDA approval of the device in patients with OAB-related UUI.
All patients have been enrolled and undergone implant procedures in phase 2 of the SANS-UUI clinical trial (NCT04232696), exploring the safety and efficacy of the Neuspera Implantable Sacral Neuromodulation (SNM) System in patients with urinary urge incontinence (UUI) associated with overactive bladder (OAB), announced Neuspera, the developer of the device, in a news release.1
Final results from phase 2 of the trial are expected in the first half of 2024.
The prospective, single-arm SANS-UUI study enrolled patients with OAB-related UUI who were screened and implanted with the device across 26 centers in the US and Europe. Patients included in the study have failed or are not a candidate for more conservative treatment or have failed or could not tolerate treatment with medication.2
“As the coordinating investigator for the SANS-UUI clinical trial, I’m excited at the prospects of the Neuspera System for treating patients with OAB symptoms in the least invasive manner,” said Osvaldo F. Padron, MD, in the news release.1 Padron is a urologist at Florida Urology Partners in Tampa, Florida.
According to Neuspera, results 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.
“Completing patient enrollment and implants is an important milestone in Neuspera’s journey towards revolutionizing the way physicians utilize SNM therapy,” said Chief Medical Officer of Neuspera Medical, Steve Siegel, MD, in the news release.1 “We’re grateful to the patients and physicians partnering with us in this study, and we look forward to finalizing the data that will support our FDA submission of the Neuspera System.”
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 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 months with 2 hours of daily stimulation. Clinically and statistically significant improvements in UUI from baseline were observed through 9 months of follow-up.
Further, 52% of patients were completely dry at 12-month follow-up. The investigators determined 2 hours per day of stimulation to be safe and effective in patients with UUI.3,4
Phase 2 of the study will further assess 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 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.
Final results from phase 2 of the trial are expected in the first half of 2024.
References
1. Neuspera Medical, Inc. completes patient enrollment and implants for the SANS-UUI pivotal clinical trial. News release. Neuspera Medical, Inc. December 6, 2023. Accessed December 7, 2023. https://neuspera.com/neuspera-medical-inc-completes-patient-enrollment-and-implants-for-the-sans-uui-pivotal-clinical-trial/
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 December 7, 2023. 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 December 7, 2023. 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, 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
