Plymouth-based medical technology company Urotronic is launching an early feasibility trial for a new drug-coated balloon treatment for narrowed urethras in men, a company announcement says.
The trial will gather information on the feasibility of the Optilume drug-coated balloon, which is inserted into a patient's narrowed urethra and inflated to dilate the canal that allows urine to leave the bladder. The balloon has a proprietary coating that includes the anti-inflammatory drug paclitaxel, which is intended to prevent reclosure of the urethra.
Urethral stricture disease involves progressive narrowing of the urethra, often leading to pain and "weak stream," especially in men over the age of 55. Urethral strictures are often caused by infection, trauma, and medical procedures that injure the lining of the urethra. There are more than 1.5 million doctors' office visits per year to treat urethral strictures, Urotronic said.
Although an open surgical procedure called "urethroplasty" exists to effectively treat strictures, more than 95 percent of men choose a less invasive procedure like standard dilation, even though it has a high rate of recurrence.
"Men, in general cringe at the idea of an open urethroplasty," said Dr. Sean Elliott, principal investigator of the Optilume trial and director of the reconstructive urological surgery program at the University of Minnesota.
The Optilume procedure is supposed to make dilation more effective by applying an anti-inflammatory drug directly to the site of the stricture.
The clinical trial, called ROBUST-II, will be a five-year study of 15 male patients treated with the Optilume device at centers in Minneapolis, Woodbury, Iowa City and elsewhere.
