First and only non-invasive, Medicare-covered at-home therapy for post-prostatectomy urinary incontinence— available over the counter
NEWTOWN, Conn., March 31, 2026 /PRNewswire/ -- Elidah today announced FDA clearance of Elitone for Men, a non-invasive, at-home treatment designed to help men regain bladder control after prostate surgery, addressing a significant and often overlooked men's health condition. Urinary incontinence, or bladder leakage, is one of the most common and disruptive complications following prostate procedures, yet men have had few options to actively support recovery at home.
Urinary incontinence affects millions of men, particularly following prostate surgery, and can significantly impact daily life, confidence, physical activity, and overall quality of life. Up to 80% of men experience bladder leakage immediately after surgery, and approximately 20% continue to experience moderate to severe symptoms one year later. Despite how common the condition is, many men underestimate its impact or expect it to resolve quickly, often delaying treatment and missing the opportunity to improve recovery earlier.
Elitone for Men is an easy-to-use, non-invasive, external therapy that delivers neuromuscular stimulation to activate and strengthen the pelvic floor muscles, supporting pelvic health for men and improving bladder control. The therapy is designed for use at home in just 20 minutes per day, enabling consistent, structured treatment without needing invasive procedures or clinic visits. In clinical studies, men using the device demonstrated:
- Significantly faster improvements in continence, reaching by 8 weeks the level of recovery seen in control patients at 12 weeks.
- By 12 weeks, patients using the device achieved a 92% reduction in leakage compared to 68% in the control group.
"Recovery improves with active rehabilitation, especially in the early weeks after surgery. Elitone for Men delivers structured at-home therapy that helps patients regain continence and get back to normal faster," said Dr. Joseph Renzulli, urologist at Yale Medicine.
Available over the counter, the therapy can be used immediately following surgery and is also covered by Medicare for eligible patients. This combination of accessibility and reimbursement provides a new pathway for patients to begin therapy earlier in their recovery. Elitone for Men is currently available for preorder, with availability in the United States expected later in April 2026.
"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," said Eric Kolb, co-founder of Elidah. "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."
Elitone for Men reflects Elidah's broader approach to advancing pelvic health for men and women through non-invasive, at-home therapies. The Elitone platform delivers targeted neuromuscular stimulation designed to strengthen pelvic floor muscles and, in other applications, help address symptoms of overactive bladder (OAB), including urgency and frequency. This dual approach highlights the potential for more comprehensive, at-home solutions across multiple types of bladder dysfunction. Learn more at elitoneformen.com.
About Elidah: Elidah is a medical device company based in Connecticut, USA, focused on developing non-invasive, at-home therapies for pelvic floor disorders. Its Elitone® platform includes FDA-cleared solutions for both women and men and has supported tens of thousands of users. https://elitone.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/new-fda-cleared-at-home-treatment-helps-men-regain-bladder-control-after-prostate-surgery-302729552.html
SOURCE Elidah
