Urethral StrictureROBUST-IIINCT03499964
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
A study testing Optilume Drug Coated Balloon (DCB) in people with Urethral Stricture, run by Urotronic Inc. at 22 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Optilume Drug Coated Balloon (DCB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 22 Jun 2018to Aug 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 31Show fewer
- 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
- 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.
- Current active infection in the urinary system
- Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes
- 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.
- Visible hematuria in subject's urine sample without known contributing factor
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
Chesapeake Urology Research
Annapolis, Maryland, 21401
Western New York Urology Associates
Cheektowaga, New York, 14225
Carolina Urology Partners
Concord, North Carolina, 28025
UT Southwestern
Dallas, Texas, 75390
Advanced Urology Institute
Daytona Beach, Florida, 32114
Chesapeake Urology
Hanover, Maryland, 21076
University of Iowa
Iowa City, Iowa, 52242
Arkansas Urology
Little Rock, Arkansas, 72211
University of Minnesota Department of Urology
Minneapolis, Minnesota, 55445
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
Iris Cantor Men's Health Center
New York, New York, 10065
Integrated Medical Professionals OBP
North Hills, New York, 11042
Adult & Pediatric Urology, PC
Omana, Nebraska, 68114
Academic Urology and Urogynecology of Arizona
Phoenix, Arizona, 85027
Mayo Clinic
Rochester, Minnesota, 55905
Urology San Antonio
San Antonio, Texas, 78229
University of Washington Harborview Medical Center
Seattle, Washington, 98104
Oregon Urology Institute
Springfield, Oregon, 97477
Urology of Virginia
Virginia Beach, Virginia, 23462
New Jersey Urology
Voorhees Township, New Jersey, 08043
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
Official title: ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial
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).
Read the 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
- Being tested
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Keywords
- pivotal trial, randomized, lower urinary tract symptoms (LUTS), urethral stricture, obstruction
- Medical subject headings
- Urethral Stricture, Lower Urinary Tract Symptoms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control TreatmentDevice
Also called Uncoated dilation balloon, Direct Vision Internal Urethrotomy (DVIU), Rigid Rod
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
| Study group | Role | What they receive |
|---|---|---|
| Optilume Treatment | Experimental | The treatment arm will be the Urotronic Optilume Drug Coated Balloon (DCB). Receives: 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. Receives: Device: Control Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Safety: Rate of Major Device or Procedure Related Complications
Rate of Major Device or Procedure Related complications
Measured: 3 months
Secondary outcomes (2)
Change in Qmax (Peak Flow Rate)
Change in peak urinary flow rate (Qmax) from baseline to 6 months post treatment. Positive values indicate an increase in Qmax from baseline to 6 months, while negative values indicate a decrease in Qmax.
Measured: 6 months
IPSS Percent Responder (50% Improvement in IPSS Score)
The proportion of subjects considered to be therapeutic responders, defined as an improvement of greater than or equal to 50% in the International Prostate Symptom Score [IPSS] without repeat intervention, in the Optilume DCB arm at 12 months will be compared to a performance goal of 50%. The IPSS was developed to measure symptom severity for bladder outlet obstruction, with a range of 0 (no symptoms) to 35 (worst possible symptoms).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start22 Jun 2018
- Primary completion10 Dec 2020
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc., NAMSA
- Responsible party
- Sponsor
- Investigators
- Sean Elliott, MD, Principal investigator, University of MinnesotaRamon Virasoro, MD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499964
- Sponsor's protocol ID
- PR1076
- Acronym
- ROBUST-III
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2018
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34854748
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03499964
- Acronym / sponsor ID
- ROBUST-III / PR1076
- Conditions
- Urethral Stricture
- Keywords
- pivotal trial, randomized, lower urinary tract symptoms (LUTS), urethral stricture, obstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc., NAMSA
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optilume Treatment | Experimental | Device: Optilume Drug Coated Balloon (DCB)The treatment arm will be the Urotronic Optilume Drug Coated Balloon (DCB). |
| Control Treatment | Active comparator | Device: Control TreatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Optilume Treatment |
| Control TreatmentAlso: Uncoated dilation balloon, Direct Vision Internal Urethrotomy (DVIU), Rigid RodA 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 | Device | Control Treatment |
Primary outcome
Percentage of Subjects Stricture Free
Time frame: 6 months
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.
Safety: Rate of Major Device or Procedure Related Complications
Time frame: 3 months
Rate of Major Device or Procedure Related complications
2 secondary outcomes
Change in Qmax (Peak Flow Rate)
Time frame: 6 months
IPSS Percent Responder (50% Improvement in IPSS Score)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34854748Elliott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Elliott, MD principal investigator
University of Minnesota
Ramon Virasoro, MD principal investigator
US Department of Veterans Affairs
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilume Drug Coated Balloon (DCB) in people with Urethral Stricture, run by Urotronic Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Stricture Free (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.