In total, the prospective SOPHIA study enrolled 6 men with stress urinary incontinence who have reduced outlet resistance due to intrinsic sphincter deficiency.
The target enrollment has been met for the first-in-man SOPHIA trial (NCT05547672) exploring the feasibility of the UroActive System, a smart artificial urinary sphincter for patients with stress urinary incontinence (SUI).1
In total, the prospective SOPHIA study2 enrolled 6 men with SUI 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.
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.
"We are delighted with the rapid enrollment and positive early results we're seeing in our SOPHIA study. And with the treatment of our final study subject complete, we are now following the full clinical cohort in preparation for the pivotal study on our unique UroActive System,” Pierre Mozer, MD, chief medical officer and co-founder of UroMems, stated in the news release.1
According to UroMems, the developer of the technology, 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 recently granted Safer Technologies Program (STeP) Designation from the FDA,3 and the first-ever implantation of thedevice in a female patient was successfully completed.
Initial results from the first patient enrolled in the SOPHIA study were announced by UroMems earlier this year.4 The patient underwent implantation in November 2022, and the procedure was done by principal investigator of the study Emmanuel Chartier-Kastler, MD.
Data showed that the primary end points of the study were achieved with no revisions necessary at 6-months' follow-up. The patient also experienced restored social continence following the procedure. Additionally, the device showed positive outcomes in regard to secondary markers, including improvements in leak rate values, among other measures.
"We are indebted to these men for their participation in the SOPHIA study, and their enthusiastic response to their personalized therapy is heartening. This clinical investigation began less than a year ago and soon we will have 6-month follow-up results for the complete cohort,” Hamid Lamraoui, UroMems chief executive officer and co-founder, stated in the news release.1
According to UroMems, final results of the trial will help to inform the study design for a pivotal SUI trial in Europe and the United States.
1. UroMems completes first-in-man study enrollment of smart implant for stress urinary incontinence. News release. UroMems. September 12, 2023. Accessed September 18, 2023. https://www.prnewswire.com/news-releases/uromems-completes-first-in-man-study-enrollment-of-smart-implant-for-stress-urinary-incontinence-301924845.html
2. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Clinical investigation to assess a new artificial urinary sphincter to treat urinary incontinence in men (SOPHIA). Last updated September 14, 2023. Accessed September 18, 2023.https://clinicaltrials.gov/study/NCT05547672
3. UroMems granted Safer Technologies Program Designation from FDA for smart implant to treat stress urinary incontinence. News release. UroMems. April 20, 2023. Accessed September 18, 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
4. UroMems announces results of first patient in smart implant study to treat stress urinary incontinence. News release. UroMems. June 6, 2023. Accessed September 18, 2023. https://www.prnewswire.com/news-releases/uromems-announces-results-of-first-patient-in-smart-implant-study-to-treat-stress-urinary-incontinence-301843679.html