Hypothesis / aims of study
Severe female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency remains challenging to treat, particularly in patients with persistent symptoms after previous surgical interventions. Although conventional hydraulic artificial urinary sphincters (AUS) can be used in selected cases, their use in women remains limited due to limited access, technical complexity, and ergonomic considerations.
The aim of this study was to evaluate the feasibility, safety, and clinical performance of a novel smart AUS, UroActive® (UroMems), in women with severe SUI. We report the one-year follow-up results.
Study design, materials and methods
This prospective, multicenter, single-arm study included female patients meeting predefined eligibility criteria who underwent implantation of the UroActive® device in a single procedure using a robotic laparoscopic approach.
The UroActive® AUS (UroMems) consists of an occlusive cuff (OC) and a control unit (CU), which includes a reservoir, a pump, and an electronic system (Fig.1) allowing wireless adjustment of device parameters (e.g., pressure) by the physician using a clinician programmer. Patients void using a patient remote control (PRC) as needed. The device is activated 6 weeks after implantation.
Follow-up visits were scheduled at day 14, day 30, day 90, day 185, and day 365, and annually thereafter up to 5 years post-activation. Patients completed 1-hour pad weight tests (1H-PWT) and quality-of-life questionnaires at day 185, day 365, and annually thereafter. Adverse events were recorded at each visit.
This study is registered at ClinicalTrials.gov (NCT05044923).
Results
Six women with a median age of 67 years (IQR 61–71) were implanted at two study sites. Five patients had a history of previous incontinence surgeries (bulking agents [n=2], TVT [n=1], TOT [n=1], combined TVT, TOT and mini-sling [n=1]). At baseline, the median 1H-PWT was 178 g (IQR 36–301).
All six devices were successfully activated.
At day 185 post-activation, all patients achieved ≥50% reduction in 1H-PWT, with a median reduction of 98% (IQR 95–99). Median maximum flow rate (Qmax) was 32 mL/s (IQR 22–51), and median post-void residual (PVR) was 12 mL (IQR 0–25). Median pad use decreased from 5.5 pads/day (IQR 3.5–7.0) at baseline to 1.5 pads/day (IQR 0–2.5).
At day 365 post-activation, all patients achieved ≥75% reduction in leakage, with a median reduction of 98% (IQR 97–99). Median pad use further decreased to 1.0 pad/day (IQR 0–3.0). Uroflowmetry parameters remained within normal ranges, with a median Qmax of 30 mL/s (IQR 13–45) and median PVR of 9 mL (IQR 0–20). Median ICIQ-SF score was 23 (IQR 22–24).
No unanticipated adverse events or device explantations were reported at one year.
Interpretation of results
This first-in-woman prospective multicenter study demonstrates substantial and sustained improvement in urinary continence with the UroActive® sphincter. Objective leakage, as measured by pad weight testing, decreased by approximately 97–98% at one year, with all patients achieving clinically meaningful improvement.
These efficacy outcomes were accompanied by a favorable safety profile, with no explants, revisions, or unexpected adverse events during the first year of follow-up. Preservation of Qmax and low post-void residual volumes indicate that continence improvement was achieved without compromising voiding function.