Uroplasty bets big on incontinence nerve zapper

It may seem a bit strange to think about treating incontinence by zapping a nerve in the foot.

Yet executives at Minnetonka-based Uroplasty Inc. bet the company on it.

The company's Urgent PC Neuromodulation System -- the official name of the product -- is not new. It was approved by the Food and Drug Administration in 2006.

But payment for the procedure has been spotty, since the product is generally not reimbursed by Medicare and, by extension, most private insurers. Still, U.S. sales of the system hummed along, reaching the $7 million mark in fiscal 2009 before plummeting to $3.8 million in fiscal 2010.

The decline occurred after the American Urological Association, a group of some 9,000 urologists, suggested that Uroplasty get a new code for Medicare billing and collect more data to prove the Urgent PC system is safe and effective. The organization stopped recommending to its specialists the payment code that had been used in the past.

The small company found itself at a critical juncture. Do another study testing the product, without knowing the final results? Or continue on, and watch sales of the system wither.

"At first, we all took a deep breath," CEO David Kaysen said. "In the end, it was an easy decision."

Treatment options are vast and potentially confounding to patients. "By the time patients get to the diaper stage, they're usually ready to look for alternatives," said Thomas Gunderson, a Piper Jaffray analyst who follows several companies marketing incontinence devices.

Beyond devices, treatment may involve drugs, behavioral therapy, surgery, even Botox injections.

Generally, payment by Medicare is crucial to ensure the financial success of a medical device. So Uroplasty ponied up $2.5 million to conduct a new clinical trial, which compared stimulation of the tibial nerve in the ankle to a "sham" procedure, a method common for testing drugs, but fairly unusual in medical technology. The company had already conducted a study comparing its tibial stimulator to a drug commonly prescribed for incontinence.

The procedure calls for a needle to be inserted near the ankle, with a battery-powered stimulator sending slight electrical impulses to a group of nerves at the base of the spine called the sacral nerve plexus that control bladder activity.

It takes about 30 minutes, and 12 weekly visits are recommended. Each visit costs about $250, and after the initial round, patients return every 21 days for a treatment.

The study ultimately showed that 55 percent of the subjects who received the real stimulation reported moderately or markedly improved responses, meaning they urinated less frequently and with less urgency. The sham arm reported a 22 percent improvement, which was attributed to a "placebo effect." Results of the study were published in the Journal of Urology in April.

Even though just a little over half of the study subjects improved, small steps can make a huge difference in a patient's life, said Nancy Kolb, Uroplasty's vice president of global marketing. It may be the difference between patients holding down a job and being unemployed, she noted.

'They wish they were dead'

"Nobody ever died of these problems, but sometimes they wish they were dead," said Dr. Steven Siegel, director of the Centers for Continence Care & Female Urology at Metro Urology in Woodbury. "Incontinence may defeat a person. It colors their entire perception of the world. It limits the number of trips they can take outside the home.

"They can't interact with friends, or go see their grandkids. It can have a really significant affect on their quality of life."

Gunderson said patients' first reaction to tibial nerve stimulation for incontinence might be puzzlement. "It's one of those, 'You do what?' It may seem counter-intuitive at first, but it's all connected to the same nervous system."

In May, Uroplasty announced that it had received a new Medicare billing code for the Urgent PC procedure, which will take effect Jan. 1. Rates have not been established yet. The company is busy with its sales and marketing efforts to prepare for a re-launch of the product.

"All of this wasn't fun," said Kaysen, of the expense and uncertainty related to the additional clinical study. "But we're absolutely a better company as a result."