Test devices aim to relieve burden of urinary incontinence

Three clinical trials might lead to new treatments for women, especially in low-resource and rural locations.

When it comes to urinary incontinence – involuntary urine leakage – many women just put up with it. They may be too embarrassed to mention it to their doctor, or feel too busy with day-to-day responsibilities to prioritize their health. Moreover, hardships created by COVID-19 have only increased reluctance to seek care. 

Given that 43% of U.S. women over age 50 experience urinary incontinence, a lot of women likely are suffering needlessly, said Dr. Suzette Sutherland, UW Medicine's director of female urology and a University of Washington School of Medicine associate professor of urology. Urinary incontinence can be caused by diet, stress, pregnancy or aging. 

“Life’s greatest adventure shouldn’t be searching for the nearest bathroom," she said. “We want women to know that there are such easy solutions available today, and new technological advances all the time."

Sutherland is involved in three clinical trials designed to make urinary incontinence more manageable.

Women experience the condition in different ways. The main two involve an overactive bladder and a feeling of urgency associated with a nagging or uncontrollable urge to void. One treatment for bladder-urgency is called neuromodulation, a therapy used for more than 20 years to treat bladder and pelvic disorders.  All three of the clinical trials are evluating prospective advancements to this technology.

Download video soundbites of Dr. Suzette Sutherland

“Neuromodulation sends electrical stimulation to the nerves in the pelvic area that then redirect or modulate the pelvic nerves in order to get the bladder to calm down,” Sutherland explained. She described the current implantable devices as “pacemakers” for the pelvic nerves that can reduce or eliminate the need for regular checkups. 

Implantation of the pacemaker device requires getting to a surgeon at a hospital that offers the therapy.  For residents of rural or low-resource settings, this can be a significant or insurmountable burden if it requires hours of driving and time away from work and home.  

If the clinical trials have favorable outcomes that lead to FDA device approval, the technologies may offer relief to women in remote and low-resource areas, Sutherland said.  

“We know neuromodulation works; it’s providing patients with proper access that is often the limiting step."

The first device being tested in a clinical trial uses only a small electrode implanted in the ankle. The electrode is controlled by an external (non-implanted) generator by way of an ankle bracelet that sends impulses through nerves up the leg to the pelvic region. The main prospective advantage is that it would allow women to do neurostimulation sessions on their own at home, even daily if needed. This trial includes several sites throughout Europe and the United States, including UW Medicine’s Pelvic Health Center.

The second trial involves a device whose electrode is about the size of a small pill and is implanted through a needle in the lower back alongside one of the main pelvic nerves. The lead is stimulated by an external (non-implanted) generator about the size of a small battery which the women secure within their underwear. 

The third device is a soft, rubber ring with embedded electrodes placed in the vagina like a pessary or diaphragm.  With this device, nothing is surgically implanted and the device can be easily removed at any time.  This device sends stimulation through the vaginal walls to the pelvic nerves to calm the bladder.

“With these advances in technology that allow for limited-to-no implanted material, all three of these new treatment devices open up new possibilities to women who might otherwise experience barriers to neuromodulation therapy.  Women interest in learning more about these trials can email blissr@uw.edu or call 206.356.0240.

– Barbara Clements - bac60@uw.edu. 253.740.5043 

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