Study shows feasibility of UroActive System in men with SUI
All of those enrolled in the study have been implanted for at least 7 months, with the longest implantation at 15 months.
The 6-month primary end points have been met in the first-in-man, prospective SOPHIA trial (NCT05547672) exploring the feasibility of the UroActive System, a smart artificial urinary sphincter for men with stress urinary incontinence (SUI).
"The results of this study will allow us to prepare our pivotal study which will be a major step in the development of UroActive," says Pierre Mozer, MD, PhD.
Findings from the multicenter study were announced by UroMems, the developer of the device, in a news release.1
"The very compelling results of this first-in-man clinical study demonstrate the high potential of our technology and pave the way for larger clinical trials that will allow us to demonstrate all the benefits we are expecting to offer patients suffering from debilitating SUI," said Hamid Lamraoui, chief executive officer and co-founder of UroMems, in the release.1 "We could not have reached this important milestone without the enthusiastic participation of the men in this initial study cohort. We're extremely grateful to them for being a vital part in bringing this potentially revolutionary treatment to market."
Overall, the trial enrolled and implanted 6 adult men with urinary incontinence who have reduced outlet resistance due to intrinsic sphincter deficiency. All patients underwent implantation of the UroActive Device at either La Pitié-Salpêtrière University Hospital (AP-HP) at Sorbonne University in Paris, France, or at Nantes University Hospital in Nantes, France.2 All of those enrolled in the study have been implanted for at least 7 months, with the longest implantation at 15 months.
The primary outcome measures for the study include the rate of device activation successes at 5 weeks and the rate of explants and revisions at 6 months following implantation. Secondary outcome measures include improvements in 24-hour pad weight test, patient satisfaction, and adverse events.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.
According to UroMems, the UroActive device is the first smart active electronic artificial urinary sphincter to treat SUI, and it is adjustable based on each patients’ individual activity. The investigational device was granted Safer Technologies Program (STeP) Designation from the FDA earlier this year.4
The company also noted that the findings from the SOPHIA trial will help to inform the design and implementation of a larger pivotal trial in the US and Europe.
Pierre Mozer, MD, PhD, UroMems chief medical officer and co-founder, concluded in the news release, "We're so pleased to see that our expectations about our device's performance were met or even exceeded and delighted to successfully treat and receive such high praise from patients who had been suffering from SUI for years. The results of this study will allow us to prepare our pivotal study which will be a major step in the development of UroActive.”1
References
1. 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 December 14, 2023. https://www.prnewswire.com/news-releases/uromems-reaches-significant-milestone-successful-results-in-clinical-feasibility-study-of-uroactive-smart-implant-for-stress-urinary-incontinence-treatment-302014290.html
2. UroMems completes first-in-man study enrollment of smart implant for stress urinary incontinence. News release. UroMems. September 12, 2023. Accessed December 14, 2023. https://www.prnewswire.com/news-releases/uromems-completes-first-in-man-study-enrollment-of-smart-implant-for-stress-urinary-incontinence-301924845.html
3. Clinical investigation to assess a new artificial urinary sphincter to treat urinary incontinence in men (SOPHIA). ClinicalTrials.gov. Last updated September 14, 2023. Accessed December 14, 2023. https://clinicaltrials.gov/study/NCT05547672
4. UroMems granted Safer Technologies Program Designation from FDA for smart implant to treat stress urinary incontinence. News release. UroMems. April 20, 2023. Accessed December 14, 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
