FemPulse Wearable Aims to Disrupt Overactive Bladder Treatment

SAN FRANCISCO, CA – March 04, 2026 – Bioelectronic medicine company FemPulse is poised to capture the attention of the global urology community after announcing its pivotal clinical study has been selected for a high-profile presentation at the American Urological Association (AUA) annual conference. The presentation, scheduled for May 15, 2026, in Washington, D.C., will feature the company’s novel wearable device designed to treat overactive bladder (OAB), a chronic condition that diminishes the quality of life for up to 40% of women worldwide.

The selection for the AUA’s “Clinical Trials in Progress” program, which highlights studies expected to substantially influence medical practice, provides significant validation for FemPulse’s innovative approach. It signals a potential paradigm shift in a market long dominated by pharmaceuticals with high discontinuation rates and invasive surgical procedures.

The Pervasive Challenge of OAB Treatment

Overactive bladder is more than an inconvenience; it is a progressive and often debilitating condition characterized by urinary urgency, frequency, and incontinence. Its economic toll is staggering, estimated at over $82 billion in the United States alone, with the majority reflecting direct healthcare spending. The global OAB treatment market, valued at nearly $3.8 billion in 2023, is projected to exceed $5.2 billion by 2030, driven by an aging population and increasing disease prevalence.

Despite the clear need, the current treatment landscape is fraught with challenges. First-line therapies typically involve behavioral changes and oral medications, such as anticholinergics and beta-3 agonists. However, these drugs are notorious for their side effects, which can include dry mouth, constipation, and cognitive impairment. Consequently, patient adherence is remarkably low, with studies showing that 70% to 80% of patients abandon their medication within six months due to a lack of efficacy or intolerable side effects.

For women who fail these initial treatments, the next step often involves more invasive options. These include Botox injections into the bladder muscle or surgically implanted sacral neuromodulation (SNM) devices from established players like Medtronic and Axonics. While effective, SNM therapy is a third-line treatment that requires a surgical procedure, and its adoption remains low, with less than 5% of eligible candidates ever receiving the therapy. This creates a vast treatment gap for millions of women who are dissatisfied with medication but are not ready or willing to undergo surgery.

A New Paradigm: Bioelectronic Neuromodulation in a Wearable Ring

FemPulse aims to fill this critical gap with its first-of-its-kind, wearable neuromodulation ring. The device is a flexible, wireless ring that a woman can insert and remove herself, much like a diaphragm or vaginal contraceptive. Once in place in the upper vagina, it is self-retained and designed for continuous, discreet wear. The device features eight programmable surface electrodes that deliver mild electrical pulses to target the complex network of nerves responsible for communication between the bladder and the spinal cord.

By modulating these nerve signals directly and non-invasively, the FemPulse Ring aims to restore normal bladder function without the systemic side effects of medication or the risks and recovery associated with surgery. This patient-centric “set it and forget it” design represents a move towards empowering women with a self-managed, first-line therapy that aligns with research confirming a strong patient preference for a wearable device over other treatment modalities.

Prior research, including four earlier studies involving 51 subjects, has already established a strong safety profile for the device while providing promising signals of efficacy. In one key in-home study, 83% of patients using the FemPulse device experienced a significant reduction in daily urgent voids, a stark contrast to the 33% seen in the control group.

The EVANESCE-II Trial: A Landmark Study on a Prestigious Stage

The upcoming AUA presentation will focus on the ongoing EVANESCE-II pivotal study, a prospective, multi-center randomized controlled trial (RCT) involving up to 151 women with OAB. The trial’s design is particularly noteworthy, as it is a rare instance of the FDA approving a head-to-head comparison of a medical device against a standard-of-care OAB medication. Subjects in the trial are randomized on a 2:1 basis to receive either the FemPulse Ring or the commonly prescribed drug.

This device-versus-drug trial structure underscores the regulatory and clinical recognition of the profound unmet need for better non-pharmacological options. A positive outcome could position the FemPulse Ring not as a last resort, but as a viable first-line alternative to pills.

Dr. Suzette E. Sutherland, the study's Principal Investigator, highlighted the significance of this approach. “I am excited to again serve as PI for this pivotal trial after seeing the previous positive results,” she stated in the company’s press release. “FDA’s rare approval of a device vs. drug trial underscores the great need for a simple, non-invasive device option for the enormous OAB patient population.”

Adding further credibility is the involvement of Dr. Roger Dmochowski, a leading figure in urology, as the study's Independent Safety Monitor. “I agreed to serve as the safety monitor for FemPulse’s pivotal trial based on the strong safety profile demonstrated previously,” Dr. Dmochowski noted. “After two decades involvement with OAB reimbursement, I am also acutely aware of the potential benefits to patients, providers, and payors of this unique non-surgical neuromodulation option.”

Presenting the ongoing trial at the world’s largest gathering of urologists provides FemPulse with an unparalleled platform to educate key opinion leaders and future prescribers about its technology long before it reaches the market. It builds crucial momentum and awareness, setting the stage for smoother physician adoption upon commercial launch. The company's investigational device is also advancing toward clearance in the European Union, potentially providing an earlier entry into the global market. As the medical community awaits the full results, the presentation at AUA marks a pivotal moment for a technology that could soon empower millions of women to reclaim control over their daily lives.