Artificial urinary sphincter for SUI shows safety, efficacy in prospective study

Data from the AUSCO trial (NCT04088331) were presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada, showing that the artificial urinary sphincter (AUS) demonstrated positive rates of continence and an acceptable safety profile in men with stress urinary incontinence (SUI).¹

Melissa R. Kaufman, MD, PhD, FACS

In an interview with Urology Times®, presenting author Melissa R. Kaufman, MD, PhD, FACS, touched on the significance of these findings for future developments of the AUS device. Specifically, she explained how these prospective findings provide a baseline for outcomes of trials going forward.

Kaufman is the Patricia and Rodes Hart professor in urologic surgery, as well as a professor of urology and chief of the Division of reconstructive urology and pelvic health at Vanderbilt University Medical Center in Nashville, Tennessee.

Urology Times: Could you describe the background/rationale for this study?

Kaufman: The hydraulic artificial urinary sphincter used for male stress urinary incontinence was developed over 50 years ago. Through the decades, multiple technical advances have come about for the device. We've come up with antibiotic impregnation, tubing modifications, expansion of cuff sizes, refinement of all our surgical techniques, but what we are looking towards is the real future of the artificial urinary sphincter. Despite having over 50 years of data and vast practical experience, most of the literature [on the] AUS device is retrospective.

What we embarked upon to be able to develop the next set of technology and the next trials is a prospective, multi-institutional analysis of artificial urinary sphincter outcomes, or AUSCO, to assess efficacy, safety, and quality of life. We needed to establish some baseline standardized data for regulatory imperatives. We know the device remains a marvelous option and a standard of care therapy for stress incontinence for men, but we want to advance technologies, and this trial will be the benchmark for research reporting in the future.

Urology Times: What were the key findings from the trial?

Kaufman: We had 17 sites and implanted 115 patients. Of course, like in most incontinence trials, the primary end point really looks at a 50% improvement [in 24-hour pad weight]. In this case, we used a very stringent goal of a 24-hour pathway at 1 year out from activation of the device.

We demonstrated almost 94% of patients met that that primary end point. That was fantastic. There were some other very prominent findings, including that the majority, 60%, were pad-free at this time point. Urinary incontinence is one of the most cited reasons for decisional regret after treatment for prostate cancer. This prospective trial, where we see the majority of men achieving total continence and a very modest serious adverse event rate, tells us that this device remains transformational for improvement and patient quality of life following any type of prostate treatment.

Urology Times: How does this study inform how or when urologists should be offering AUS to their patients?

Kaufman: We found some fascinating aspects to the study. For one, our guidelines have really liberalized the fact that AUS may be the appropriate therapy after shared decision-making for patients for mild to severe incontinence. Certainly, in select patient populations like those who have had a history of pelvic radiation, it is a preferred modality of treatment.

[In our study,] up to a third [of patients] had a history of diabetes, and over 20% had a history of radiation, but none of those things affected their clinical outcomes or their adverse event rate. This is noteworthy because it wasn't in agreement with what we've seen in a lot of retrospective trials, particularly regarding radiation and increased rate of complications. The caveat is that we were only looking at a 1-year time point. We weren't looking further out. Many of those studies evaluate patients in a much longer time frame.

Most remarkably, in the entire cohort of 115 subjects, there were no device infections. That is the most feared complication of artificial sphincter. Perhaps it was that we were at clinical trial sites; it was at high-volume implanters.

But overall, it was a very robust study with modest adverse event rates that will hopefully expand people's knowledge and offering of this very transformational therapy for patients. It's a durable solution for male stress incontinence with very low complication rates and very high satisfaction rates.

Urology Times: What next steps are planned for this research?

Kaufman: We're also going to be publishing manuscripts that discuss what it does for depression [and] what having an artificial sphincter does for sexual function. The impact is very profound. What's coming next are [also] technological advances with active implantable devices. We believe that this is going to be our baseline data, [and] these types of advances are going to improve outcomes, lower revision rates, and expand indications for AUS placement in the future.

REFERENCE

1. Wood H, Peterson A, Chaussee E, et al. Primary results from the multi-institutional, prospective artificial urinary sphincter clinical outcomes (AUSCO) trial. 2025;213(5S):e44. doi:10.1097/01.JU.0001109716.61721.8d.07