UroActive System shows promise in first female patient with SUI

Initial data from a study (NCT05828979) of the UroActive System, a smart artificial urinary sphincter for the treatment of stress urinary incontinence (SUI), show that the first female patient to be implanted with the device has reached the study’s 6-month primary end points, according to a news release from UroMems, the developer of the technology.¹

The UroActive System is the first smart active implant to treat SUI.

"We are elated to reach this critical achievement contributing to the demonstration of the feasibility of the UroActive System to successfully treat women suffering from debilitating SUI," said UroMems chief executive officer and co-founder Hamid Lamraoui in the news release.¹ "The compelling results of this first-in-female implant show the high potential of our technology, bringing us one step closer to delivering on the massive unmet need for women and physicians desperately seeking a better SUI treatment option."

The first female patient enrolled in the study was implanted with the device in July 2023. The procedure was performed by Emmanuel Chartier-Kastler, MD, PhD, Aurélien Beaugerie, MD, and Christophe Vaessen, MD, at La-Pitié-Salpêtrière University Hospital in Paris, France.

Overall, the patient met the study’s primary outcome measures of successful device activation and the rate of explants and revisions at 6 months. In addition to remaining revision-free, the patient has also experienced restored social continence. Secondary measures, including leak rate values, have also showed a trend toward positive outcomes.

The UroActive System is the first smart active implant to treat SUI. The device is powered by a MyoElectoMechanical System (MEMS) and is controlled based on a patient’s activity, without the need for manual adjustments. The technology is placed around the urethra in men and around the bladder neck in women.

The device was granted Safer Technologies Program (STeP) Designation from the FDA in 2023,² which is intended to allow more timely access to new products that have the potential to be safer than currently approved options, while maintaining the FDA’s standards for safety and effectiveness. Further, the UroActive System is currently being studied in the SOPHIA study (NCT05547672), which is assessing the device in men with SUI. Results from the study were published in December 2023, demonstrating proof of feasibility in this patient population.³

At the time of data report, no revisions nor explants of the device have been necessary, and all devices are working as expected. The investigators also observed positive outcomes regarding the trial’s secondary end points of leak rate values and patient quality of life questionnaires.

In total, the study enrolled 6 men with SUI who have reduced outlet resistance due to intrinsic sphincter deficiency. The primary end points are the rate of explants and revisions at 6 months following activation of the device, as well as the rate of device activation successes at 5 weeks after implantation.

According to UroMems, the findings from the SOPHIA trial, alongside findings from the current study in female patients, will help to inform the design and implementation of a pivotal clinical trial of the device in the US and Europe.

References

1. UroMems announces results of first-ever smart artificial urinary sphincter implant in female patient to treat stress urinary incontinence. News release. UroMems. February 14, 2024. Accessed February 19, 2024. https://www.prnewswire.com/news-releases/uromems-announces-results-of-first-ever-smart-artificial-urinary-sphincter-implant-in-female-patient-to-treat-stress-urinary-incontinence-302061348.html

2. UroMems granted Safer Technologies Program Designation from FDA for smart implant to treat stress urinary incontinence. News release. UroMems. April 20, 2023. Accessed July 24, 2023. https://www.prnewswire.com/news-releases/uromems-granted-safer-technologies-program-designation-from-fda-for-smart-implant-to-treat-stress-urinary-incontinence-301803090.html

3. UroMems reaches significant milestone: Successful results in clinical feasibility study of UroActive Smart Implant for stress urinary incontinence treatment. News release. UroMems. December 13, 2023. Accessed February 19, 2024. https://www.uromems.com/en/press/article/10/uromems-reaches-significant-milestone-successful-results-in-clinical-feasibility-study-of-uroactive-smart-implant-for-stress-urinary-incontinence-treatment