Hypothesis / aims of study
The Artificial Urinary Sphincter (AUS) is currently the gold standard treatment for severe stress urinary incontinence in men. It is also a treatment option for women in Europe, especially in case of sub-urethral slings failure [1]. The most widely implanted AUS in Europe and the United States is the AMS 800™. This device is a passive hydraulic device and the urethral occlusion pressure is transmitted by the Pressure Regulating Balloon (PRB). PRB pressure is a fixed (usually 61- 70 cm H2O as a consensus validated value [2]) and cannot be adjusted after implantation. The clinical efficacy of the device has been widely proven in both men and women nevertheless with a significant rate of revision and explantation.
The UroMems Artificial Urinary Sphincter (AUS), UroActiveTM (UroMems, France), is an implantable device designed to treat stress urinary incontinence for males and females which includes a reservoir, a pump and electronic components that allow setting device parameters wirelessly with a Clinician Programmer (CP) and for the patient to void with a Patient Remote Control (PRC).
We report preliminary data at 90 days post-activation follow-up of the first male patient implanted with this new artificial urinary sphincter.
Study design, materials and methods
This study is a prospective, open-label, non-randomized, multi-center, single-arm, study with subjects acting as their own control designed to test the feasibility of this therapy.
• Primary Outcome Measures are rate of explants and revisions at 6 months after device activation and rate of device activation successes.
• Main Secondary Outcome Measure is the number of subjects with 50% reduction or greater in 24-hour pad weight test at 90, 185 and 365 days after activation.
Six patients are planned.
After the implantation and a healing period of 5 weeks, the device is activated (ACT). Two Follow-Up (FU) visits are planned at day 14 (D14) and day 30 (D30) post-activation to adjust the parameters of the device according to patient feedback on continence.
The device (Figure 1) is composed of an occlusive cuff (OC) connected to a Control Unit (CU) which includes a reservoir, a pump and electronic components that allow for setting device parameters wirelessly with a Clinician Programmer (CP). As with the AMS800™, the OC is placed around the bulbar urethra in men and around the bladder neck in women. In contrast, the CU is placed in the abdomen, above the rectus aponeurosis, so no intra-abdominal surgery is required (Figure 2).
The patient can void and control the level of device pressure using a dedicated Patient Remote Control (PRC). Two levels of pressure can be set: Baseline Pressure for everyday activities or Low Pressure to apply when lying-down. Each level of pressure can be personalized with the CP.
The device implements a failsafe function “UroTimer”, allowing the device to be automatically deactivated if the patient does not void during a certain period (eg 12hours).
Data, including device pressure and PRC use, are recorded by the device and can be downloaded with the CP.
UroactiveTM is neither CE Marked nor FDA approved yet.
Results
Study started September 2022.
The device was successfully implanted and activated.
An adverse event, unrelated to the device, occurred 56 days (D56) post-activation, which led to an automatic deactivation of the device with the “UroTimer” failsafe function. Device was reactivated, without any trouble, 3 weeks later at 77 days post-activation (D77).
Low Pressure level was unchanged at 10cmH2O during the follow-up.
Baseline Pressure level was changed at each FU visits based on patient feedback. Median (IQR) Baseline Pressure measured in the device was 36(14), 47(12), 58(20) and 65 (17)cmH20 during period ACT-D14, D14-D30, D30-D56 and D56-D90 respectively
The patient performed a mean of 8,7 micturitions/day and spent a mean time of 8 hours/day with Low Pressure level in the device.
At 90 days follow-up, the average 24-hour pad weight test was 11g, compared to 125g before activation.
Interpretation of results
For this First in Man implantation, UroActive AUS met the safety and efficacy targets at 3 months post-activation.