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Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study | Clinical Trials | Clareo Health

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Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study

NCT03851952•Urotronic Inc.

View on ClinicalTrials.gov

Summary

The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for 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 retrograde urethrogram
•3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm
•4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs).
•5. IPSS score of 13 or higher
•6. Lumen diameter \<12F by urethrogram
•7. Able to complete validated questionnaire independently
•8. Qmax \<15 ml/sec
•9. Guidewire must be able to cross the lesion

Exclusion Criteria

•1. Strictures greater than 3.0 cm long
•2. Subjects with greater than 1 stricture.
•3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
•4. Previous urethroplasty within the anterior urethra
•5. Stricture due to bacterial urethritis
•6. Stricture due to untreated gonorrhea
•7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO)
•8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization)
•9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult
•10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
+20 more criteria

Key Dates

Start Date

May 31, 2019

Primary Completion Date

October 31, 2020

Completion Date

December 31, 2024

Last Updated

July 12, 2019

Conditions

Urethral StrictureUrethral Stricture, AnteriorLower Urinary Tract SymptomsAnterior Urethral Stricture

Interventions

Optilume Drug Coated Balloon

DEVICE

RCT on Running Water Sound During Urodynamic

NCT07451548

Lower Urinary Tract Symptoms (LUTS)

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RECRUITINGPHASE4

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

NCT06795074

Urethral Stricture

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RECRUITINGPHASE4

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

NCT05383274

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: July 12, 2019Data 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 - Registry Study

Inclusion Criteria

Exclusion Criteria

RCT on Running Water Sound During Urodynamic

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

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

PRescription Exercise for Older Men With Urinary Disease