U.S. Food and Drug Administration (FDA) Approves Clinical Trial of drug-coated balloon catheter
Truckee, CA (UroToday.com) Doctors are beginning a clinical study of a new medical solution that could dramatically change the way urethral strictures are treated today for millions of men around the world.
The Optilume™ drug-coated balloon (DCB), developed by Urotronic, based in Plymouth, MN, represents the first substantial investment in urology in a medtech field often dominated by advancements in cardiology and oncology.
“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,” says Dr. Sean Elliott, who directs the program in reconstructive urological surgery at the University of Minnesota.
Dr. Elliott is the principal investigator of the FDA-approved clinical trial of Optilume. The U.S. based trial, known as ROBUST II, recently received FDA approval for an Investigational Device Exemption (IDE). The early feasibility study will be conducted at 5 medical centers around the country including the University of Iowa, University of Utah, Eastern Virginia Medical Center and the University of Minnesota and Metro Urology in Minneapolis.
There are roughly 1.5 million doctors’ office visits in the U.S. to treat urethral strictures, which block the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary system. Urethral strictures are often caused by infections, trauma and other medical procedures that injure the lining of the urethra. The number of urological procedures is expected to grow rapidly as Baby Boomers age and are more susceptible to urinary tract problems, according to doctors involved in the clinical trial.
The most common treatments, balloon dilation and another endoscopic intervention known as an urethrotomy, both have high rates of recurrence. An open surgical procedure called urethroplasty, another treatment option for urethral stricture, has a much better success rate however, it may require a longer recovery and includes painful side effects.
“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,” says Elliott. “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.”
That’s why Dr. Elliott and his colleagues around the world are so interested in the ROBUST II clinical trial. For them, and millions of men around the world, the drug-coated balloon solution represents a potential treatment option that could be more effective in treating urethral strictures without painful, surgical side effects.
“We're optimistic that the drug coated balloon catheter will dramatically improve the quality of life of men suffering daily from the symptoms of urethral strictures,” says Dr. Jessica DeLong, with Eastern Virginia Medical Center. “There’s added benefit that this procedure would have a much shorter recovery and lower risks than an open surgical urethroplasty.As with other medtech advancements it is the drug-coated balloon that could be a difference maker. Scar tissue quickly develops after any medical intervention. The Optilume DCB combines balloon dilation, to expand or widen the strictured area, and the delivery of an anti-proliferative drug which has already been proven effective at limiting scar tissue generation in cardiovascular applications.
“The fact that they thought about adding the drug, I think that’s the ingenious part,” says Dr. Ramon Virasoro, who practices with Dr. DeLong at Urology of Virginia. “This is a problem that makes people very unhappy and a lack of an effective minimally invasive treatment option can lead men to delay care to the point where it really affects their quality of life.”
Urotronic’s solution may also be a response to changes underway in healthcare delivery where the emphasis is shifting to outcomes as opposed to fee-for-service models.
The American Urological Association recently updated its treatment guidelines to include a discussion of the most effective treatments for men with recurrent urethral strictures. Dr. Elliott says treatments have actually undergone very few changes in centuries.
“If the drug-coated balloon proves to be effective, that would really change the game in how I am counseling patients,” he said.
Dr. Elliott and other investigators will monitor the progress of the ROBOUST II clinical trial, which get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
Definition of Successful Treatment and Optimal Follow-up after Urethral Reconstruction for Urethral Stricture Disease.
Primary non-transecting bulbar urethroplasty long-term success rates are similar to transecting urethroplasty.
A Nationwide Assessment of the Emergency Department Management of Acute Urinary Retention Due to Urethral Stricture.