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Treating Urethral Strictures

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.

Participant Eligibility

Inclusion:
Males
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.

Exclusion:
Previous urethroplasty
Difficulty have a catheter inserted

Contact

Mike Donahue
(206) 290-8294

Additional Study Details

Full Study Title
Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease – A Randomized Control Trial

Study ID: 20181066
Start Date: 08/13/2018
End Date: 05/03/2020

Investigator(s)
Judith Hagedorn, MD, MHS
Niels Johnsen, MD

Accepts Healthy Volunteers?
No

Study Site(s)

Harborview Medical Center

325 9th Avenue
Seattle, Washington 98104



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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