Stricture UrethraEarly Phase 1ROBUSTNCT03014726
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
A Early Phase 1 study testing Urotronic Drug Coated Balloon (DCB) in people with Stricture Urethra, run by Urotronic Inc. at 1 site in United States.
Trial summary
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stricture Urethra
- What is being tested?
- Urotronic Drug Coated Balloon (DCB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Apr 2023
- Phase
- Early Phase 1
- 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 lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
- One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) 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 UTI's.
- IPSS score of 13 or higher
Show all 9Show fewer
- Lumen diameter <12F by urethrogram
- Able to complete validated questionnaire independently
- Qmax <10 ml/sec
Who cannot join
- Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry
- Previous urethroplasty within the anterior urethra
- Stricture due to bacterial urethritis or untreated gonorrhea
Show all 15Show fewer
- Stricture dilated or incised within the last 3 months
- 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 such as BPH at the discretion of the clinical investigator
- Previous radical prostatectomy
- Previous pelvic radiation
- Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
- 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.)
- Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
Read the detailed description
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).
Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
- Conditions
- Stricture Urethra
- Being tested
- Urotronic Drug Coated Balloon (DCB)
- Keywords
- reduced urine flow rate, low peak flow rate, urinary tract infections
- Medical subject headings
- Urethral Stricture, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urotronic Drug Coated Balloon (DCB)Combination product
Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.
| Study group | Role | What they receive |
|---|---|---|
| DCB Treatment | Experimental | Stricture patients treated by DCB Receives: Combination Product: Urotronic Drug Coated Balloon (DCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment Related Serious Complication
- urethral formation of fistula
- de novo severe urinary retention lasting > 14 consecutive days' post-treatment
- unresolved de novo stress urinary incontinence (requiring >1 pad/day) at 90 days or earlier
- urethra rupture or burst.
Measured: 90 days post-procedure
Secondary outcomes (1)
Stricture Recurrence Rate
- IPSS score of greater than 11 at the 90-day follow-up, or
- if a subject had a second DCB treatment (retreatment), or
- if a subject exited the study early due to treatment failure (IPSS >11 without cystoscopically confirmed anatomical success at the time of exit or receiving additional stricture treatment with an alternative therapy).
Measured: 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionOct 2018
- Study completionApr 2023
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 Stricture UrethraStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Schorn, Study director, Urotronic (Study Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014726
- Sponsor's protocol ID
- DSC016
- Acronym
- ROBUST
- Status last verified
- Sep 2023
- First submitted
- 5 Jan 2017
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
DeLong J, Virasoro R, Pichardo M, Estrella R, Rodriguez Lay R, Espino G, Elliott S. Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study. J Urol. 2025 Jan;213(1):90-98. doi: 10.1097/JU.0000000000004229. Epub 2024 Aug 30.
PubMed 39213367
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
- ClinicalTrials.gov ID
- NCT03014726
- Acronym / sponsor ID
- ROBUST / DSC016
- Conditions
- Stricture Urethra
- Keywords
- reduced urine flow rate, low peak flow rate, urinary tract infections
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
Detailed description
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).
Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB Treatment | Experimental | Combination Product: Urotronic Drug Coated Balloon (DCB)Stricture patients treated by DCB |
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 lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
- One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) 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 UTI's.
Key exclusion criteria (15 listed)
- Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry
- 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)Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers. | Combination product | DCB Treatment |
Primary outcome
Rate of Treatment Related Serious Complication
Time frame: 90 days post-procedure
* urethral formation of fistula * de novo severe urinary retention lasting > 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring >1 pad/day) at 90 days or earlier * urethra rupture or burst.
1 secondary outcome
Stricture Recurrence Rate
Time frame: 90 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39213367DeLong J, Virasoro R, Pichardo M, Estrella R, Rodriguez Lay R, Espino G, Elliott S. Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study. J Urol. 2025 Jan;213(1):90-98. doi: 10.1097/JU.0000000000004229. Epub 2024 Aug 30.
- 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.
Ian Schorn study director
Urotronic (Study Sponsor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Urotronic Drug Coated Balloon (DCB) in people with Stricture Urethra, run by Urotronic Inc. at 1 site 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 9 inclusion and 15 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2024). 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?
Rate of Treatment Related Serious Complication (time frame: 90 days post-procedure). 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 NCT03014726, 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 22 Mar 2024.