Novel artificial urinary sphincter shows promise for male urinary incontinence

The UroActive implantable artificial urinary sphincter showed promising efficacy and safety as a novel option for treating male urinary incontinence, according to poster data from the first-in-human SOPHIA study (NCT05547672) shared during the 2024 American Urological Association Annual Meeting.¹

“UroActive met the safety and efficacy targets at 6 months post-activation. A multicenter and international pivotal clinical trial is planned to start,” the authors wrote in the conclusion on their poster.

The UroActive system consists of an occlusive cuff (OC) that is connected to a control unit (CU). During implantation, the clinician places the OC around the bulbar urethra and the CU is placed above the aponeurosis on the right part of the patient’s abdomen. “The patient can open the cuff to void and decrease device pressure when lying down using a dedicated remote control,” the SOPHIA authors wrote on their poster.

The device also includes a safety feature called the UroTimer that will automatically deactivate the UroActive system if the patient does not void during a specific period of time. Follow-up visits are scheduled to reset the parameters of the device, if necessary, based on patient continence and other feedback.

The open-label, multi-center, single-arm, prospective SOPHIA study included 6 patients with a median age of 69 years. All patients were incontinent following radical prostatectomy. Among these patients, implantation of the device took an average of 64 minutes (IQR, 61-69). Following implantation of the device, there is a 5-week healing period for the patient, after which the device is activated.

The 2 primary end points for the trial were the rate of successful device activation and the rate of explantation or revisions at 6 months’ follow-up. The key secondary end point was the number of patients experiencing at least a 50% reduction in 24-hour pad weight test (24H-PWT) at 3 months and 6 months following activation of the device.

According to the researchers, the devices were successfully implanted and activated in all 6 patients, and there was no explantation or revision required. There was 1 severe adverse event, consisting of a hematoma after surgery with slow urinary stream, which was self-resolved. CU data at 3 months’ post-activation showed a mean of 8 micturition/day (IQR= 3) and that patients experienced a mean of 7 hours/day (IQR = 40 minutes) with low pressure.

A 50% or higher reduction in 24H-PWT was experienced by all patients, with a median reduction of 84% (IQR = 8%). The median Qmax was 34 ml/s (IQR = 10).

There were 3 incidents in which the UroTimer safety function was set off because the time had been set too short on the function setting. It was triggered 1 additional time due to an adverse event that was not related to the UroActive device. All 4 incidents were easily resolved, with the devices being reactivated.

“UroActive met the safety and efficacy targets at 6 months post-activation. A multicenter and international pivotal clinical trial is planned to start,” the authors wrote in the conclusion on their poster.

The study was sponsored by UroMems, the developer of UroActive. The device does not currently have FDA approval or CE Marking.

References

1. Beaugerie A, Perrouin-Verbe M-A, Denormandie A, et al. The new artificial urinary sphincter UroActive™: Results of the first in man study at 3 months post-activation (SOPHIA study). Presented at: 2024 American Urological Association Annual Meeting. May 2-6, San Antonio, Texas.

2. NIH US National Library of Medicine ClinicalTrials.gov. Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men (SOPHIA). ClinicalTrials.gov Identifier: NCT05547672. First posted September 21, 2022. Last update posted September 14, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05547672