FDA clears neuromuscular stimulation device for post-prostatectomy incontinence

The FDA has granted 510(k) clearance to Elitone for Men, a non-invasive, at-home neuromuscular stimulation device designed to improve urinary incontinence after prostate surgery, Elidah announced.¹

"Recovery improves with active rehabilitation, especially in the early weeks after surgery,” explained Joseph Renzulli, MD, FACS, an associate professor of urology at Yale School of Medicine in New Haven, Connecticut.¹ “Elitone for Men delivers structured at-home therapy that helps patients regain continence and get back to normal faster, in my opinion.”

Elitone for Men is an external therapy designed to deliver neuromuscular stimulation to the pelvic floor musculature, with the goal of enhancing muscle strength and improving bladder control. The device is intended for daily home use, with a recommended duration of 20 minutes per session.

According to data cited in the company announcement, men using the device demonstrated accelerated improvement in continence compared with patients in the control arm. By 8 weeks, device users achieved levels of continence comparable to those observed in patients in the control arm at 12 weeks. At 12 weeks, patients using the device experienced a 92% mean reduction in 24-pad weight compared with 68% for patients in the control group.²

"For too long, men facing urinary incontinence after prostate surgery have had limited options to actively improve their recovery, making it one of the most frustrating parts of the process," added Eric Kolb, co-founder of Elidah, in the news release from the company.¹ "We created Elitone for Men as a simple yet powerful at-home solution designed to help patients see meaningful improvement sooner, while also being easy to use and incorporate into daily routines, giving patients a way to actively support their recovery, rather than waiting and hoping it improves."

The device will be available over the counter in the US, with anticipated availability beginning in April 2026. The company also noted that Medicare coverage may be available for eligible patients, potentially lowering barriers to access.

Elitone for Men is part of Elidah’s broader portfolio of noninvasive, home-based therapies targeting pelvic floor dysfunction in both men and women and has also been applied to manage symptoms of overactive bladder, including urinary urgency and frequency.

According to Elidah, “This dual approach highlights the potential for more comprehensive, at-home solutions across multiple types of bladder dysfunction.”

REFERENCES

1. New FDA-cleared at-home treatment helps men regain bladder control after prostate surgery. News release. Elidah. March 31, 2026. Accessed March 31, 2026. https://elitone.com/wp-content/uploads/2026/03/Elitone-for-Men-Press-Release-033126.pdf

2. Elitone for Men. Elidah. Accessed March 31, 2026. https://elitone.com/men/