Urethral StrictureROBUST-IINCT03270384
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
A study testing Urotronic Drug Coated Balloon (DCB) in people with Urethral Stricture, run by Urotronic Inc. at 5 sites in United States.
Trial summary
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture. 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?
- Urotronic Drug Coated Balloon (DCB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Oct 2017to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 lesion anterior urethral stricture less than or equal to 3 cm
- Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual 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 UTI's (urinary tract infections).
- IPSS (International Prostate Symptom Score) score of 13 or higher
Show all 10Show fewer
- Lumen diameter <12F by urethrogram
- Able to complete validated questionnaire independently
- Qmax <12 ml/sec
- Guidewire must be able to cross the lesion
Who cannot join
- Strictures greater than 3.0 cm long.
- Subjects that have more than 1 stricture.
- Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Subjects who have a suprapubic catheter
- Previous urethroplasty within the anterior urethra
- Stricture due to bacterial urethritis or untreated gonorrhea
Show all 13Show fewer
- Stricture dilated or incised within the last 3 months
- History of over active bladder or stress incontinence
- Previous radical prostatectomy
- Previous pelvic radiation
- Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
- Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chesapeake Urology
Hanover, Maryland, 21076
University of Iowa
Iowa City, Iowa, 52242
University of Minnesota
Minneapolis, Minnesota, 55455
Urology of Virginia
Virginia Beach, Virginia, 23462
Metro Urology
Woodbury, Minnesota, 55125
About this study
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
- Conditions
- Urethral Stricture
- Being tested
- Urotronic Drug Coated Balloon (DCB)
- Keywords
- early feasibility, non-randomized
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urotronic Drug Coated Balloon (DCB)Device
The Urotronic 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB) Receives: Device: Urotronic Drug Coated Balloon (DCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Rate of Device Related Serious Complications
Measured: 90 days
Secondary outcomes (2)
Safety- Change in IIEF (International Index of Erectile Function)
Measured: 90 days
Efficacy- Stricture Recurrence Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start25 Oct 2017
- Primary completion1 Nov 2019
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Elliott, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270384
- Sponsor's protocol ID
- PR1032
- Acronym
- ROBUST-II
- Status last verified
- Jul 2025
- First submitted
- 30 Aug 2017
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
- ClinicalTrials.gov ID
- NCT03270384
- Acronym / sponsor ID
- ROBUST-II / PR1032
- Conditions
- Urethral Stricture
- Keywords
- early feasibility, non-randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Urotronic Drug Coated Balloon (DCB)Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male subjects ≥ 18 years' old
- Visual confirmation of stricture via cystoscopy or urethrogram
- Single lesion anterior urethral stricture less than or equal to 3 cm
- Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual 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 UTI's (urinary tract infections).
Key exclusion criteria (13 listed)
- Strictures greater than 3.0 cm long.
- Subjects that have more than 1 stricture.
- Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Subjects who have a suprapubic catheter
- Previous urethroplasty within the anterior urethra
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 |
|---|---|---|
| Urotronic Drug Coated Balloon (DCB)The Urotronic 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 | Treatment |
Primary outcome
Safety- Rate of Device Related Serious Complications
Time frame: 90 days
2 secondary outcomes
Safety- Change in IIEF (International Index of Erectile Function)
Time frame: 90 days
Efficacy- Stricture Recurrence Rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urotronic Drug Coated Balloon (DCB) in people with Urethral Stricture, run by Urotronic Inc. at 5 sites in United States.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety- Rate of Device Related Serious Complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.