First Remote-Controlled Device for Male Incontinence in U.S. Implanted at Duke

Millions of men face daily challenges with stress urinary incontinence that diminishes their quality of life, including those who survive prostate and other pelvic cancers.

A surgical team at Duke Health has performed the first U.S. implantation of a new remote-controlled artificial urinary sphincter that aims to give men who struggle with incontinence after treatment for pelvic cancers a more personalized and discreet way to manage bladder control. The announcement comes at the start of Prostate Cancer Awareness Month, a time when attention often turns to survivorship issues that affect men long after treatment.

Peterson said about 10% to 20% of men develop enough incontinence after prostate cancer treatment that they have to wear diapers or pads. He is the co-principal investigator of a clinical trial to determine the safety and effectiveness of the electronic artificial urinary sphincter. The study is funded by the device manufacturer, UroMems.

The current gold-standard surgical treatment involves a manually operated artificial urinary sphincter that requires a patient to manually squeeze a pump implanted inside the scrotum to urinate. For some men, especially those who are older or have limited mobility, operating the pump can be difficult. Others report feeling self-conscious using it in a public setting.

“Some men become reclusive,” Peterson said. “They don't go out to dinner, they don't go dancing, they don’t do the things they love because they're anxious about leaking urine.”

The new electronic device packs a pump, reservoir, and battery into a small metal encasement, similar to a pacemaker, which is implanted in a patient’s abdomen just under the skin. It’s operated by a remote control the size of a car key fob.

When the patient wants to urinate, he pushes a button on the remote which sends a signal to the device to open a cuff around the urethra, allowing urination. The device is set to a cycle which automatically closes the cuff to stop the flow and is adjustable based on the person’s activity.

The FDA approved an investigational device exemption in 2025, allowing the device to be studied in the clinical trial.

“Our trial will follow patients for up to five years because the goal isn’t just effectiveness — it’s safety, durability, and a real improvement in quality of life,” said Peterson.

A prospective study in France followed six men at one year after implantation of the electronic device. The study found it to be safe and effective, reducing urinary leakage by more than 75% in 80% of the men. This study was also funded by the manufacturer of the device.

The study plans to enroll up to 140 men at several sites in the U.S. and France.

References:

1. https://www.newswise.com/articles/first-remote-controlled-device-for-male-incontinence-in-u-s-implanted-at-duke

2. https://www.auajournals.org/doi/10.1097/JU.0000000000004945

3. https://clinicaltrials.gov/study/NCT06968741

(Newswise/APC)