LAS VEGAS — After decades of use, the artificial urinary sphincter (AUS) finally has high-level evidence of its safety and efficacy for stress urinary incontinence (SUI) in men. What’s more, patients like it.

More than 90% of patients had at least a 50% reduction in sanitary pad weight over 12 months; daily pad use declined by about 80%, daily incontinence events decreased by more than 60%, and quality-of-life (QoL) measures all improved significantly. Depression improved significantly, and patient-reported satisfaction with the device remained high throughout a prospective multicenter clinical evaluation.

The results set a benchmark for objective 24-hour pad use and subjective, patient-reported outcomes that future studies should follow to inform decision making, said Melissa R. Kaufman, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tennessee, at the American Urological Association meeting.

“This study really reflects real-world experiences, what we’re seeing in our clinics on a day-t0-day basis,” said Kaufman. “I think this trial probably is one of the most representative because of the latitude of the inclusion criteria and also because of the representation of the medical comorbidities that we would anticipate, such as diabetes and coronary artery disease.”

“Earlier [in the session] we heard about how stress and urge incontinence occurs in this population,” she added. “We saw decreases in urge incontinence and overall decreases in any incontinence episode, so [the AUS] did not treat just some stress component with concomitant urge. This will be important to look at in the future… . I would also like to [highlight] that we saw zero infectious adverse events that required explants in this population of 115 men.”

Following the presentation, an unidentified member of the audience asked about the absence of infections, noting that 0% infection rate is a rare occurrence in the literature on post-treatment urinary incontinence.

“That finding might be a little biased, because we had 17 very high-volume centers that have entire systems that are very agile and that may have their own particular protocols,” said Kaufman. “We did not script protocols with regard to perioperative antibiotics or perioperative chlorhexidine washes or anything that had to be done for the patients. It was all per [the centers’] standard of care.

In response to another question, Kaufman said the trial did not have a strict definition of “high volume” for the participating centers. Participation was based on centers’ historical use of AUS, and study sponsor Boston Scientific vetted some of the centers. She also noted that the trial was conducted during the COVID pandemic, and allowances were made from recruitment challenges.

A recent publication from France showed better outcomes at centers that perform more than 20 AUS implants annually versus fewer than five.

“It seems we could say that at least five [procedures] per year are necessary but the best centers would do more than 10,” said an unidentified speaker who participated in the French study.

Long History, Limited Hard Data

The AUS has been standard of care for SUI in men for about 50 years, particularly in the post-treatment setting for prostate cancer. For most of that time, no broadly accepted definitions existed for metrics and outcomes used to determine efficacy. A decade ago, an international consensus group published a comprehensive document to provide guidance for use of the AMS800, the most commonly used AUS worldwide.

The Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO) represented the first attempt at rigorous application of the standards set forth in the consensus document to clinical management of male SUI. Previous studies had been single-center and/or retrospective evaluations, said Kaufman.

AUSCO involved 17 high-volume centers in the U.S. and Australia. The primary objective was improvement in 24-hour pad weight after 12 months. Investigators enrolled 115 men who had a mean age of 70 and a median body mass index of 30.8. All but five of the men (95.7%) had SUI following radical prostatectomy, and 25 (21.7%) had radiotherapy at some point.

Of 97 evaluable patients, 91 (93.8%) met the goal of at least a 50% reduction in 24-hour pad weight at 12 months (P<0.001), and 83 (85.6%) met the more stringent response criterion of at least a 75% reduction. Daily SUI events decreased from 1.7 to 0.4, urge incontinence events from 1.2 to 0.6, and any urinary incontinence events from 5.2 to 2.1.

Adverse events (AEs) occurred in a third of patients, serious AEs in 15%, and serious AEs due to use of the device in 9%, all consistent with prior literature, said Kaufman. Nine patients required revision procedures, one for lack of efficacy, two for erosion, three for mechanical malfunction, and four for other reasons.

High Marks From Patients

AUSCO included several measures of QoL, all of which showed that treating SUI improved patients’ mental health and well-being, said Andrew Peterson, MD, of Duke Health in Durham, North Carolina. Additional questionnaires showed high rates of patient satisfaction with the AUS and that patients found the device easy to use, contrary to some clinicians’ impressions.

The patients completed three mental health questionnaires at baseline and after 12 months. Results for all three showed significant improvement in situational depression, anxiety, and overall mental health (P=0.0023 to P<0.0001).

Patient-reported satisfaction with the device exceeded 90% at baseline and remained stable or improved over 12 months of use. Similarly, the patients had favorable perceptions about the device’s ease of use at baseline, and ratings improved or remained high during the study, dissuading concerns about the AUS being difficult to manipulate for obese and elderly patients.

“I think we’re really treating depression that’s situational to the patients, and we’re providing a service to men who are overweight, who are older, who may have diabetes,” said Peterson. “We had no surveys that said the device was hard or very hard to manipulate.”

In the few instances requiring explant, the patient’s first question was about replacing the device.

“You have a man who’s febrile, who has a huge scrotum, and you should be putting in the intensive care unit, and they want to know ‘How long do I have to wait before I get another device?'” said Peterson.

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