New FDA-Cleared Device Offers Men an At-Home Path to Bladder Control After Prostate Surgery

NEWTOWN, Conn. – March 31, 2026 – By Angela Gray

Men recovering from prostate surgery have a new, non-invasive tool to reclaim their quality of life, as the U.S. Food and Drug Administration (FDA) has cleared Elitone for Men, a first-of-its-kind at-home therapy for urinary incontinence. Developed by Connecticut-based medical device company Elidah, the device offers a proactive solution to one of the most common and distressing side effects of prostate procedures, providing an over-the-counter, Medicare-covered option that can be used in the privacy of one's home.

The announcement marks a significant advancement in men's health, addressing a condition that affects millions but is often endured in silence. Urinary incontinence, or bladder leakage, impacts up to 80% of men immediately following prostate surgery, and for a significant minority—approximately one in five—the problem persists with moderate to severe symptoms even a year later.

A Common but Underestimated Challenge

The physical and emotional toll of post-prostatectomy urinary incontinence is profound. It can disrupt daily routines, limit physical activity, and erode self-confidence. Many men find themselves dependent on absorbent pads or external clamps, which manage symptoms but do not treat the underlying cause. The journey to recovery is often a frustrating process of 'waiting and seeing,' with few active, non-invasive options available.

"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, in the company's announcement.

This waiting game can delay meaningful recovery. Experts note that while pelvic floor muscle training (PFMT), commonly known as Kegels, is the standard first-line conservative treatment, patient adherence can be inconsistent. Performing the exercises correctly without guidance is challenging, and many men become discouraged by slow progress. This creates a significant gap in care between self-directed exercises and more invasive surgical interventions, a gap Elitone for Men is designed to fill.

How At-Home Neuromuscular Stimulation Works

Elitone for Men utilizes targeted neuromuscular stimulation to do the work of pelvic floor exercises for the patient. The system consists of a discreet, wearable GelPad that is placed externally on the perineum (the area between the scrotum and anus) and a small, pocket-sized controller. When activated, it sends gentle electrical impulses to the pelvic floor muscles, causing them to contract and strengthen.

The therapy is designed for convenience, requiring just one 20-minute session per day. During treatment, users can walk, work, or relax, integrating the therapy seamlessly into their daily lives without the need for clinic visits or invasive procedures.

Clinical studies submitted to the FDA underscore the device's efficacy. According to Elidah, men using the device demonstrated significantly faster improvements in continence. By the 12-week mark, patients using the therapy achieved an average 92% reduction in leakage, measured by pad weight, compared to a 68% reduction in the control group. Furthermore, the study showed that device users reached the level of recovery at eight weeks that took the control group twelve weeks to achieve, effectively accelerating the rehabilitation process by a full month.

"Recovery improves with active rehabilitation, especially in the early weeks after surgery," noted Dr. Joseph Renzulli, a urologist at Yale Medicine, in a statement. "Elitone for Men delivers structured at-home therapy that helps patients regain continence and get back to normal faster."

Reshaping the Treatment Landscape

The current treatment landscape for severe male stress urinary incontinence is dominated by surgical options. The artificial urinary sphincter (AUS) is considered the 'gold standard' for its effectiveness, but it is a highly invasive procedure that many men are hesitant to undergo. Male slings are another surgical option for milder cases. Elitone for Men introduces a powerful, active therapy that sits ahead of these invasive options, empowering patients to rehabilitate their own muscles first.

Its clearance as an over-the-counter (OTC) device is a critical component of its accessibility. Men can acquire the therapy without an initial prescription, removing a significant barrier to entry. This allows for immediate use following surgery, a crucial window for active rehabilitation.

Furthermore, the device is covered by Medicare for eligible patients. Based on the precedent set by the company's device for women, Elitone for Men is classified as Durable Medical Equipment (DME). While a physician's order confirming medical necessity is required for reimbursement, Medicare Part B covers the device as a 13-month rental, after which the patient owns it. This financial accessibility, combined with its OTC status, creates a new paradigm for post-prostatectomy care.

The device is currently available for preorder on the company's website, with shipping in the United States expected to begin in April 2026. This launch places a new tool in the hands of urologists and patients, aligning with the broader healthcare trend of decentralization and empowering patients with effective, at-home medical technologies.

By providing a simple, powerful, and accessible solution, Elitone for Men not only promises to improve physical outcomes but also to destigmatize a sensitive men's health issue. It gives men a concrete action to take in their recovery, replacing passive waiting with active rehabilitation and offering a renewed sense of control over their bodies and their lives.