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Gold Standard

Experts first focused on evaluating the results of a long-term study monitoring the use of the manual hydraulic artificial urinary sphincter (AUS) designated AMS 800. It is commonly used to address male stress incontinence, which can occur after surgical treatment or radiotherapy for prostate cancer.

Ten-year data from the CEASAR study comparing the effectiveness of surgical treatment and radiotherapy for localized prostate cancer found that up to 25% of patients who underwent prostatectomy reported urine leakage. According to Dr. Sarah Faris, Associate Professor of Surgery at the University of Chicago, AUS implantation is highly effective in such cases. Treating severe stress urinary incontinence with the AMS 800 restores a full quality of life for patients.

This manual hydraulic AUS typically functions for 7–10 years. Risks associated with its implantation still exist, despite multiple improvements over its 40-year lifespan, including changes in cuff size and the addition of an antibiotic coating.

However, the prospective AUS Clinical Outcomes (AUSCO) study with 115 participants showed frequent side effects. Thirty-eight patients (33%) reported at least one complication: 10 men (8.7%) had serious device issues, 9 (7.8%) required revision implantation, 2 (1.7%) experienced erosion, and 3 (2.6%) had mechanical failure.

Digital Innovation

The 2025 AUA Annual Meeting participants then turned their attention to electronic artificial sphincters currently in development. Specifically, one-year data from a pilot study of the electronic device UroActive was presented.

UroActive is an implantable artificial urinary sphincter consisting of an occlusive cuff connected to a control unit that includes a reservoir, pump, battery, and electronic components capable of wireless communication. The cuff is placed around the bulbar urethra, and the control unit is located in the right side of the abdomen.

On the Right Track

Professor Emmanuel Chartier-Kastler of Sorbonne University in Paris presented results of a one-year study involving six men with UroActive. The wireless remote-controlled device has two settings: standing and lying down. These are programmed by a physician, and the patient can switch between them.

Professor Chartier-Kastler noted that UroActive is innovative in that it applies less pressure to the urethra when the patient is lying down and automatically opens the urethra, which is beneficial for patients with cognitive or physical impairments. All six study participants experienced incontinence after radical prostatectomy. More than 50% reduction in total pad weight over 24 hours (24-hour pad weight test) was confirmed.

A follow-up study involving around 100 participants is planned and will form the basis for an FDA approval application before market launch. A pivotal study of UroActive in women is also in preparation. An initial clinical study of six women with stress urinary incontinence showed full functionality of the device six months after implantation.

As Melissa Kaufman, Professor of Urologic Surgery and Director of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center, told Medscape Medical News, the innovations brought by electronic sphincters will provide more comfortable solutions and be available to more patients than ever before.

Editorial Team, Medscope.pr

Sources:

1. Digital Innovation Coming Soon to Incontinence Care. Medscape, April 28, 2025. Available at: www.medscape.com/viewarticle/digital-innovation-coming-soon-incontinence-care-2025a10009w2

2. Beaugerie A., Perrouin-Verbe M. A., Denormandie A. et al.: PD02-01 NEW ARTIFICIAL URINARY SPHINCTER: RESULTS OF THE FIRST IN MAN STUDY AT ONE YEAR POST-ACTIVATION (SOPHIA STUDY). The Journal of Urology 213(5S):p e41, May 2025, doi: 10.1097/01.JU.0001109716.61721.8d.01.

3. Wood H., Peterson A., Chaussee E. et al.: PD02-07 PRIMARY RESULTS FROM THE MULTI-INSTITUTIONAL, PROSPECTIVE ARTIFICIAL URINARY SPHINCTER CLINICAL OUTCOMES (AUSCO) TRIAL. The Journal of Urology, Vol.213(5S), p.e44 05/2025, doi: 10.1097/01.JU.0001109716.61721.8d.07.