First female patient implanted with smart artificial urinary sphincter for stress urinary incontinence

The first female patient has received an implant of the UroActive smart artificial urinary sphincter (AUS) for the management of stress urinary incontinence (SUI), announced UroMems, the developer of the technology, in a news release.¹

The UroActive device was granted Safer Technologies Program Designation from the FDA earlier this year.

"This is a unique accomplishment for UroMems and SUI in women. We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population,” said chief executive officer and co-founder of UroMems, Hamid Lamraoui, in the news release.¹

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. The procedure was approved by the National Agency of Medicines and Health Products, the French equivalent of the FDA in the United States.

Pierre Mozer, MD, chief medical officer and co-founder of UroMems, said in the news release,¹ "It's unacceptable that women today don't have a better option for treating their stress incontinence. Ultimately, we hope UroActive will become the therapy of choice for both physicians and their patients.”

The UroActive device is the first smart active electronic AUS, and it is adjustable based on each patients’ activity. The device was granted Safer Technologies Program (STeP) Designation from the FDA earlier this year,² and it is currently being studied in the SOPHIA study.

SOPHIA study

The SOPHIA study (NCT05547672) is currently assessing the UroActive device in men with SUI. Initial results from the study were published earlier this year.³

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

Initial data from the study showed that the first male patient, who was implanted with the device in November 2022,⁴ reached the study’s primary endpoints and experienced restored social continence.³ Additionally, the device showed positive outcomes in regard to secondary markers, which included improvements in a 24-hour pad weight test, quality of life, post void residuals, patient satisfaction, and instances of adverse events, among other measures.

Mozer added,³ "With the encouraging six-month post-activation results of our first study subject, we look forward to reviewing the balance of the follow-up data on our patients and advancing to the pivotal study stage of a potentially revolutionary SUI therapy.”

Ongoing resultsfrom the SOPHIA study, alongside results from the just-announced first-in-female implantation, will help to inform design and implementation of a pivotal clinical trial on UroActive in Europe and the United States.

References

1. UroMems announces first-ever smart articificial urinary sphincter implant in a female patient. News release. UroMems. July 20, 2023. Accessed July 24, 2023. https://www.prnewswire.com/news-releases/uromems-announces-first-ever-smart-artificial-urinary-sphincter-implant-in-a-female-patient-301882182.html#:~:text=GRENOBLE%2C%20France%20and%20MINNEAPOLIS%2C%20July,smart%2C%20automated%20artificial%20urinary%20sphincter%20

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 announces results of first patient in smart implant study to treat stress urinary incontinence. News release. UroMems. June 6, 2023. Accessed July 24, 2023. https://www.prnewswire.com/news-releases/uromems-announces-results-of-first-patient-in-smart-implant-study-to-treat-stress-urinary-incontinence-301843679.html

4. UroMems initiates first-in-human study of its smart implant to treat stress urinary incontinence. News release. UroMems. November 29, 2022. Accessed July 24, 2023. https://www.prnewswire.com/news-releases/uromems-initiates-first-in-human-study-of-its-smart-implant-to-treat-stress-urinary-incontinence-301689050.html