UroMems has completed enrolment in a clinical study investigating its automated artificial urinary sphincter to treat stress urinary incontinence (SUI).
The French company successfully implanted its UroActive device in six men with SUI in the prospective, single-arm, open-label, non-randomised, multi-centre trial (NCT05547672). According to the primary outcomes on the trial’s ClinicalTrials.gov entry, UroMems will measure rate of explants and revisions at six months post-device activation. The team will also measure the rate of activation successes at five weeks after device activation.
The male trial, called SOPHIA, is running in parallel with a female counterpart trial, called TRANSITION. Last month, the company announced the first implantation in TRANSITION.
UroMems said that results from both initial clinical studies will be used to design pivotal SUI trials in the US and Europe.
The mechatronics company is aiming to bring the first automated artificial urinary sphincter to market. Artificial sphincters are standard treatment to help control the release of urine in patients with moderate and severe stress urinary incontinence – where urine leaks out of the bladder after sudden pressure such as physical movement or activity. Normally, these are manually activated via an inserted balloon pump.
UroMems’ device is powered by a MyoElectroMechanical System which can automatically control urethral pressure. The system measures patient activity by microsensors and adjusts urethral pressure accordingly. The company says this means that when the patient’s activities do not require increased pressure, compression on the urethral tissue is relaxed – meaning the chances of tissue erosion are reduced.
In April 2023, the US Food and Drug Administration (FDA) granted UroActive with Safer Technologies Programme designation to speed up the device’s route to market.
UroMems’ CEO and co-founder Hamid Lamraoui said: “This clinical investigation began less than a year ago and soon we will have six-month follow-up results for the complete cohort.”
UroMems’ chief medical officer and co-founder Professor Pierre Mozer added: “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.”