Urotronic is launching a feasibility trial of its drug-coated balloon in men with narrowed urethras, according to StarTribune.
The Plymouth, Minn.-based company’s Optilume device is inserted into a patient’s urethra and then inflates to dilate the urethra, allowing urine to leave the patient’s bladder.
The Robust-II trial is slated to enroll 15 male patients and last for five years.
Narrowing of a patient’s urethra can cause urethral stricture disease, which results in pain and “a weak stream,” according to the company. Infection or trauma to the lining of the urethra causes urethral strictures, which ultimately add up to more than 1.5 million visits to the doctors’ office each year, Urotronic reported.
There is a surgical procedure to treat strictures, called urethroplasty, but the majority of men opt for a less invasive procedure like standard dilation.
“Men, in general cringe at the idea of an open urethroplasty and much prefer something that can be done without cutting open the genital area,” principal investigator Dr. Sean Elliott said in prepared remarks. “The numbers speak for themselves. Close to 95-98% of urethral strictures in the United States are treated with endoscopic means, meaning with a dilation or urethrotomy.
It’s exciting to see investment to treat this disease and to see a new product being offered for really the first time in history.”