02 Jan Treating Urethral Strictures
The purpose of the study is to compare the effects, good and/or bad, of the Optilume Drug Coated Balloon (DCB) to the standard treatment for urethral stricture to find out if one is better.
The Optilume DCB is a catheter with an inflatable balloon coated with a drug call paclitaxel. The balloon is intended to open up narrowing of the urethra, also called a stricture, and the drug coating is intended to prevent the stricture from coming back.
The Optilume DCB is investigational, meaning it has not been approved for use by the FDA.
The study is sponsored by Urotronics, Inc.
Urethral stricture with two or more prior dilation treatments
Symptoms of urethral structure such as frequency of urination, slow follow, feeling of incomplete emptying or painful urination.
Difficulty have a catheter inserted
Additional Study Details
Full Study Title
Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease – A Randomized Control Trial
Judith Hagedorn, MD, MHS
Niels Johnsen, MD
Accepts Healthy Volunteers?
Harborview Medical Center
325 9th Avenue
Seattle, Washington 98104