Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Completed · Not applicable

Conditions studied: Urethral Stricture

In brief

The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.

Key facts

Study ID

NCT03270384

Run by

Urotronic Inc.

People needed

16

Starts

2017-10-25

Expected to finish

2025-02-19

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male subjects ≥ 18 years' old
• Visual confirmation of stricture via cystoscopy or urethrogram
• Single lesion anterior urethral stricture less than or equal to 3 cm
• Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
• Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
• IPSS (International Prostate Symptom Score) score of 13 or higher
• Lumen diameter <12F by urethrogram
• Able to complete validated questionnaire independently
• Qmax <12 ml/sec
• Guidewire must be able to cross the lesion

You may not qualify if…

• Strictures greater than 3.0 cm long.
• Subjects that have more than 1 stricture.
• Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• Subjects who have a suprapubic catheter
• Previous urethroplasty within the anterior urethra
• Stricture due to bacterial urethritis or untreated gonorrhea
• Stricture dilated or incised within the last 3 months
• History of over active bladder or stress incontinence
• Previous radical prostatectomy
• Previous pelvic radiation
• Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
• Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
• Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Chesapeake Urology — Hanover, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Metro Urology — Woodbury, Minnesota, United States
• Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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