FDA, French ANSM greenlight pivotal trial of UroActive smart implant for male SUI

The FDA and the French National Agency for the Safety of Medicines and Health Products (ANSM) have granted an investigational device exemption (IDE) clearance to a pivotal trial of the UroActive smart implant for the treatment of stress urinary incontinence (SUI) in men, UroMems announced in a news release.¹

According to the company, the UroActive System “is placed around the urethral duct and is controlled based on the patient's activity, without the need for complex manipulation, intending to provide patients with ease of use and a better quality of life than current options.”

The trial, called SOPHIA2 (NCT06968741), will assess the safety and efficacy of the UroActive implant in treating men with SUI. The study’s co-principal investigators in the US are Melissa R. Kaufman, MD, PhD, FPMRS, professor and chief reconstructive surgery at Vanderbilt University in Nashville, Tennessee and Andrew C. Peterson, MD, FPMRS, professor at Duke University in Durham, North Carolina.

Melissa R. Kaufman, MD, PhD, FPMRS

"We have seen first-hand the shortcomings of current SUI treatment options for our male and female patients," said Kaufman in the news release.¹ "That's why we're so excited to be leading the SOPHIA2 trial, as it's showing promise to provide significant improvements in addressing these issues. Based on the feasibility study data we've seen, UroActive has the potential to be a transformational technology."

In total, the prospective, open-label SOPHIA2 trial will enroll approximately 140 male patients with SUI across clinical trial sites in the US and France. To be eligible for enrollment, patients must be at least 22 years old, have a primary diagnosis of SUI for at least 6 months, and have been deemed an appropriate candidate for surgery.²

Participants in the study will be implanted with the UroActive Artificial Urinary Sphincter device. The primary end point is the responder rate at 26 weeks following device activation. The study’s secondary end point is the proportion of patients who experience a change in overall impression of improvement (PGI-I) from baseline to 26 weeks.

Primary completion of the study is expected in December 2026.

Data on the UroActive Device

Data from the first-in-human SOPHIA study (NCT05547672) of the UroActive implant in men were presented at the American Urological Association 2024 Annual Meeting in San Antonio, Texas, showing positive outcomes on all primary and secondary end points.³

The feasibility study included a total of 6 patients. The co-primary end points for the trial were the rate of successful device activation and the rate of explantation or revisions at 6 months’ follow-up. The key secondary end point was the number of patients experiencing at least a 50% reduction in 24-hour pad weight test (24H-PWT) at 3 months and 6 months following activation of the device.

According to the investigators, the devices were successfully implanted and activated in all 6 patients, and there were no explants nor revisions required. There was 1 severe adverse event, consisting of a hematoma after surgery with slow urinary stream, which was self-resolved.

A 50% or higher reduction in 24H-PWT was experienced by all patients, with a median reduction of 84% (IQR, 8%). The median Qmax was 34 ml/s (IQR, 10).

The UroActive device is also under investigation in women with SUI and has demonstrated comparable results in the clinical feasibility study.⁴ In February 2024, UroMems reported that all 6 patients had been successfully implanted with the device, with no need for revision nor explant. Patients also showed positive outcomes on the trial’s secondary end points of leak rate values and patient quality of life questionnaires.

Professor Emmanuel Chartier-Kastler

"We've seen exceptionally strong results for both men and women in France as part of the feasibility clinical study, including over 1 year with no need for revision nor explant and extremely high praise from patients who had been suffering from SUI for years," concluded Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University and Pitié-Salpêtrière Hospital in Paris, in the news release.¹ "We look forward to conducting the pivotal SOPHIA2 study in France in lock step with the US sites."

REFERENCES

1. UroMems receives clearance from the FDA and the French ANSM for initiating landmark pivotal clinical study of UroActive Smart Implant to treat male stress urinary incontinence. News release. UroMems. July 17, 2025. Accessed July 17, 2025. https://www.prnewswire.com/news-releases/uromems-receives-clearance-from-the-fda-and-the-french-ansm-for-initiating-landmark-pivotal-clinical-study-of-uroactive-smart-implant-to-treat-male-stress-urinary-incontinence-302507146.html

2. A Study to Assess the Safety and Effectiveness of the UrOActive Artificial Urinary sPHincter (AUS) (SOPHIA2). ClinicalTrials.gov. Last updated May 21, 2025. Accessed July 17, 2025. https://clinicaltrials.gov/study/NCT06968741

3. Beaugerie A, Perrouin-Verbe M-A, Denormandie A, et al. The new artificial urinary sphincter UroActive: Results of the first in man study at 3 months post-activation (SOPHIA study). Presented at: 2024 American Urological Association Annual Meeting. May 2-6, San Antonio, Texas.

4. UroMems announces successful results in first-ever female clinical feasibility study of UroActive Smart Implant for stress urinary incontinence treatment. News release. UroMems. February 20, 2024. Accessed July 17, 2025. https://www.uromems.com/en/press/article/22/uromems-announces-successful-results-in-first-ever-female-clinical-feasibility-study-of-uroactive-smart-implant-for-stress-urinary-incontinence-treatment