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

NCT03499964 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: PR1076
• Study Type: interventional
• Target: 127
• Locations: 2 countries
• Sites: 22

Brief Summary

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).

Conditions

Urethral Stricture

Keywords

pivotal trial; randomized; lower urinary tract symptoms (LUTS); urethral stricture; obstruction

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Stricture Free

  The percentage of subjects deemed to be stricture free will be compared between arms. Stricture free subjects are those for which a 16F flexible cystoscope or 14F Foley catheter is able to be passed through the treated stricture without significant resistance.

  6 months

• Safety: Rate of Major Device or Procedure Related Complications

  Rate of Major Device or Procedure Related complications

  3 months

Secondary Outcomes (2)

• Change in Qmax (Peak Flow Rate)

  6 months

• IPSS Percent Responder (50% Improvement in IPSS Score)

  12 months

Study Arms (2)

Optilume Treatment

EXPERIMENTAL

The treatment arm will be the Urotronic Optilume Drug Coated Balloon (DCB).

Device: Optilume Drug Coated Balloon (DCB)

Control Treatment

ACTIVE COMPARATOR

The control arm will be treated by a urethral dilation method considered to be best standard of care for the study site and subject. A control treatment may be either a rod, uncoated balloon or DVIU.

Device: Control Treatment

Interventions

Optilume Drug Coated Balloon (DCB) DEVICE

The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.

Optilume Treatment

Control Treatment DEVICE

A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician

Also known as: Uncoated dilation balloon, Direct Vision Internal Urethrotomy (DVIU), Rigid Rod

Control Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• Urotronic Inc.: lead
• Laborie Medical Technologies Inc.: collaborator
• NAMSA: collaborator

Study Sites (22)

Academic Urology and Urogynecology of Arizona

Phoenix, Arizona, 85027, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Chesapeake Urology Research

Annapolis, Maryland, 21401, United States

Location

Chesapeake Urology

Hanover, Maryland, 21076, United States

Location

University of Minnesota Department of Urology

Minneapolis, Minnesota, 55445, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

Adult & Pediatric Urology, PC

Omaha, Nebraska, 68114, United States

Location

New Jersey Urology

Voorhees Township, New Jersey, 08043, United States

Location

Western New York Urology Associates

Cheektowaga, New York, 14225, United States

Location

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States

Location

Iris Cantor Men's Health Center

New York, New York, 10065, United States

Location

Integrated Medical Professionals OBP

North Hills, New York, 11042, United States

Location

Carolina Urology Partners

Concord, North Carolina, 28025, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Royal Victoria Hospital, Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Elliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C, Virasoro R. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume(R) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2022 Apr;207(4):866-875. doi: 10.1097/JU.0000000000002346. Epub 2021 Dec 2.

  PMID: 34854748 RESULT

MeSH Terms

Conditions

Urethral Stricture; Lower Urinary Tract Symptoms; Bites and Stings

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: Urotronic, Inc

info@urotronic.com

763-285-7489

Study Officials

• Sean Elliott, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Ramon Virasoro, MD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: June 22, 2018
• Primary Completion: December 10, 2020
• Study Completion: March 1, 2026
• Last Updated: October 15, 2025
• Results First Posted: June 6, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (21)