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

NCT ID: NCT03499964

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2026-03-31

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).

Detailed Description

ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device.

This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The interim analysis will be be undertaken following completion of the 6-month follow-up data from these subjects. Based on the results of the interim analysis, the final total sample size required for the study will be re-estimated. A minimum of 140 subjects, and a maximum of 200 subjects (pending the re-estimation) will be enrolled in the study. A Data Monitoring Committee (DMC) will review the interim analysis results, including the sample size re-estimation and make recommendations related to trial continuation to the sponsor.

Conditions

Urethral Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Optilume Treatment

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

Group Type: EXPERIMENTAL

Optilume Drug Coated Balloon (DCB)

Intervention Type: 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.

Control Treatment

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.

Group Type: ACTIVE_COMPARATOR

Control Treatment

Intervention Type: 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

Interventions

Optilume Drug Coated Balloon (DCB)

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.

Intervention Type: DEVICE

Control Treatment

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

Intervention Type: DEVICE

Other Intervention Names

Uncoated dilation balloon; Direct Vision Internal Urethrotomy (DVIU); Rigid Rod

Eligibility Criteria

Inclusion Criteria

1. Male subjects ≥ 18 years' old

2. Visual confirmation of stricture via cystoscopy or urethrogram

3. 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).

4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision 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 urinary tract infections (UTI's).

6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)

7. Lumen diameter ≤ 12F by urethrogram

8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present)

9. Guidewire must be able to cross the lesion

Exclusion Criteria

1. 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).

2. 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.

3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment.

4. Previous urethroplasty within the anterior urethra

5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation)

6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.

7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician

8. Diagnosis of untreated and unresolved BPH or BNC

9. Untreated stress urinary incontinence (SUI).

10. History of diagnosed radiation cystitis.

11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years

12. 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.

13. Diagnosis of chronic renal failure and treatment with hemodialysis

14. New diagnosis of OAB (overactive bladder) within the last six (6) months

15. 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.)

16. Dependence on Botox (onabotulinumtoxinA) in urinary system

17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate

18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)

20. Previous hypospadias repair

21. 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

22. 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

23. Unwilling to use protected sex for thirty (30) days' post treatment

24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential.

25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements

26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed.

27. Current active infection in the urinary system

28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes

29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function.

30. Visible hematuria in subject's urine sample without known contributing factor

31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Laborie Medical Technologies Inc.

INDUSTRY

Sponsor Role: collaborator

NAMSA

OTHER

Sponsor Role: collaborator

Urotronic Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Elliott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Ramon Virasoro, MD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

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

Omaha, 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

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 34854748 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PR1076

Identifier Type: -

Identifier Source: org_study_id