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Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease | Clinical Trials | Clareo Health

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

NCT03270384•Urotronic Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Strictures greater than 3.0 cm long.
•2. Subjects that have more than 1 stricture.
•3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
•4. Subjects who have a suprapubic catheter
•5. Previous urethroplasty within the anterior urethra
•6. Stricture due to bacterial urethritis or untreated gonorrhea
•7. Stricture dilated or incised within the last 3 months
•8. History of over active bladder or stress incontinence
•9. Previous radical prostatectomy
•10. Previous pelvic radiation
+3 more criteria

Locations (5)

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

Key Dates

Start Date

October 25, 2017

Primary Completion Date

November 1, 2019

Completion Date

February 19, 2025

Last Updated

November 26, 2025

Enrollment

ACTUAL participants

Conditions

Urethral Stricture

Interventions

Urotronic Drug Coated Balloon (DCB)

DEVICE

Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon

NCT06795074

Urethral Stricture

View study

RECRUITINGPHASE4

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

NCT05383274

Urethral Stricture

View study

ACTIVE_NOT_RECRUITING

Optilume Registry for Treatment of Stricture of the Anterior Urethra

NCT05479422

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Optilume Registry for Treatment of Stricture of the Anterior Urethra

Vessel-sparing Technique Versus Conventional Repair of PFUI: A Prospective Comparative Study

Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture

Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures.