ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Running, not enrolling · Not applicable

Conditions studied: Urethral Stricture

In brief

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

Key facts

Study ID: NCT03499964
Run by: Urotronic Inc.
People needed: 127
Starts: 2018-06-22
Expected to finish: 2026-08-01
Last updated by the study team: 2026-05-19

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, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision 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 urinary tract infections (UTI's).
International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)
Lumen diameter ≤ 12F by urethrogram
Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present)
Guidewire must be able to cross the lesion

You may not qualify if…

Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3.
Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment.
Previous urethroplasty within the anterior urethra
Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation)
Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
Diagnosis of untreated and unresolved BPH or BNC
Untreated stress urinary incontinence (SUI).
History of diagnosed radiation cystitis.
Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years
Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator.
Diagnosis of chronic renal failure and treatment with hemodialysis
New diagnosis of OAB (overactive bladder) within the last six (6) months
Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
Dependence on Botox (onabotulinumtoxinA) in urinary system
Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate
Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)
Previous hypospadias repair
History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment
Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
Unwilling to use protected sex for thirty (30) days' post treatment
Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential.
Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements

Where it is running

Academic Urology and Urogynecology of Arizona — Phoenix, Arizona, United States
Arkansas Urology — Little Rock, Arkansas, United States
Advanced Urology Institute — Daytona Beach, Florida, United States
University of Iowa — Iowa City, Iowa, United States
Chesapeake Urology Research — Annapolis, Maryland, United States
Chesapeake Urology — Hanover, Maryland, United States
University of Minnesota Department of Urology — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Minnesota Urology — Woodbury, Minnesota, United States
Adult & Pediatric Urology, PC — Omana, Nebraska, United States
New Jersey Urology — Voorhees Township, New Jersey, United States
Western New York Urology Associates — Cheektowaga, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital — New York, New York, United States
Iris Cantor Men's Health Center — New York, New York, United States
Integrated Medical Professionals OBP — North Hills, New York, United States
Carolina Urology Partners — Concord, North Carolina, United States
Oregon Urology Institute — Springfield, Oregon, United States
UT Southwestern — Dallas, Texas, United States
Urology San Antonio — San Antonio, Texas, United States
Urology of Virginia — Virginia Beach, Virginia, United States
University of Washington Harborview Medical Center — Seattle, Washington, United States
Royal Victoria Hospital, Glen Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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