Drug Coated Balloon for Urethral Stricture

(ROBUST-III Trial)

Not currently recruiting at 22 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urotronic Inc.

Must not be taking: Alpha blockers, Beta blockers

Disqualifiers: Cancer, Diabetes, Neurologic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a new treatment, the Optilume Drug Coated Balloon (DCB), for individuals with urethral stricture, a condition that narrows the urethra and complicates urination. The study compares this new method with the current standard treatment, which may involve stretching the urethra or cutting the narrowed section. Men who experience symptoms such as frequent urination, painful urination, or slow urine flow and have undergone at least two dilation treatments may be suitable candidates for this trial. Participants will help determine if the new treatment offers better relief than existing methods. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial requires that participants have a stable dose of certain medications like alpha blockers, beta blockers, overactive bladder medications, anticonvulsants, and antispasmodics for the last six months. If your dose isn't stable, you might need to adjust it before joining the trial.

What prior data suggests that the Optilume Stricture Drug Coated Balloon is safe for urethral stricture treatment?

Research has shown that the Optilume Stricture Drug Coated Balloon (DCB) is a safe treatment for men with recurring urethral stricture, a condition where the urethra narrows. Studies have found it effective and generally easy for patients to handle. For example, one study found that 71.9% of patients did not need another procedure three years after using Optilume. Other research indicates low rates of complications, suggesting that the treatment is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for urethral stricture, which typically involve mechanical dilation with rods, uncoated balloons, or direct visual internal urethrotomy (DVIU), the Optilume Stricture Drug Coated Balloon (DCB) offers an innovative approach. This treatment combines mechanical dilation with a drug-coated balloon that releases medication directly at the stricture site. This dual action not only helps open the urethra but also aims to reduce the risk of the stricture returning by delivering the drug right where it's needed. Researchers are excited because this targeted delivery could result in more effective and longer-lasting results compared to traditional methods.

What evidence suggests that the Optilume Stricture Drug Coated Balloon is effective for urethral stricture?

Research has shown that the Optilume Stricture Drug Coated Balloon (DCB), which participants in this trial may receive, effectively treats urethral strictures, or narrowings in the urethra. Long-term studies indicate it keeps the urethra open and reduces the risk of recurrence. Five-year data published in the Journal of Urology supports its lasting effectiveness. Patients using Optilume experienced fewer recurrences compared to those receiving standard treatments, which are part of the control arm in this trial. Overall, the Optilume DCB offers a promising and less invasive option for managing urethral strictures effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Sean Elliott, MD

Principal Investigator

University of Minnesota

Ramon Virasoro, MD

Principal Investigator

US Department of Veterans Affairs

Are You a Good Fit for This Trial?

Men over 18 with urethral stricture disease, experiencing symptoms like painful urination or frequent UTIs. They must have had at least two prior treatments for the condition but no urethroplasty, and their strictures should be less than or equal to 3 cm long.

Inclusion Criteria

The doctor needs to visually confirm a narrowing in the urinary tract using a special camera or x-ray test.

Your International Prostate Symptoms Score (IPSS) is 11 or higher. If you have a suprapubic catheter, it's assumed to be a score of 35 or higher.

I experience frequent urination, pain, urgency, blood in urine, slow flow, feeling of incomplete emptying, or recurrent UTIs.

Exclusion Criteria

I have an artificial device in my urinary system.

I am allergic to TAXOL, on conflicting medication, or have low neutrophil counts.

You have a condition that makes it hard to talk to the study doctor about the study or to fill out the study questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Optilume Drug Coated Balloon (DCB) or a control treatment for urethral stricture disease

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Extended Follow-up

Participants are monitored for long-term effectiveness and safety, including IPSS score improvement

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Treatment
• Optilume Stricture Drug Coated Balloon (DCB)

Trial Overview The ROBUST III trial is testing the safety and effectiveness of a new treatment called Optilume Drug Coated Balloon (DCB) compared to a control treatment in men with urethral stricture disease.

How Is the Trial Designed?

Group I: Optilume Treatment Experimental Treatment 1 Intervention

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

Group II: Control Treatment Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Urotronic Inc.

Lead Sponsor

Trials

10

Recruited

1,400+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Laborie Medical Technologies Inc.

Industry Sponsor

Trials

15

Recruited

1,100+

ClinLogix. LLC

Industry Sponsor

Trials

11

Recruited

1,700+

Published Research Related to This Trial

The Optilume™ paclitaxel-coated balloon treatment for recurrent bulbar urethral strictures showed no serious adverse events within 90 days, indicating a strong safety profile for this intervention.

At the 12-month follow-up, 70% of patients achieved anatomic success, suggesting promising preliminary efficacy for this treatment, warranting further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. Virasoro, R., DeLong, JM., Mann, RA., et al.[2020]

The Optilume® drug-coated balloon (DCB) demonstrated significantly higher anatomical success rates (75% vs 27%) compared to standard endoscopic management for treating recurrent anterior urethral strictures in a study of 127 male patients over 6 months.

Patients treated with the Optilume DCB experienced more durable improvements in urinary symptoms and flow rates, making it a promising alternative for those seeking to avoid more invasive procedures like urethroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures. Elliott, SP., Coutinho, K., Robertson, KJ., et al.[2022]

The Optilume™ paclitaxel-coated balloon treatment for recurrent bulbar urethral strictures showed no serious adverse events over a two-year follow-up period, indicating its safety for patients.

The treatment resulted in a significant improvement in symptoms, with 70% of patients achieving success and a notable reduction in the International Prostate Symptom Score from 25.2 to 6.9, suggesting strong efficacy in managing recurrent strictures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Mann, RA., Virasoro, R., DeLong, JM., et al.[2021]

In the ROBUST I trial, 67% of men treated with the Optilume drug-coated balloon for recurrent urethral strictures achieved functional success after 3 years, indicating effective long-term relief from symptoms.

The treatment was found to be safe, with only mild to moderate adverse events reported, and it did not negatively impact erectile function, making it a promising option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. Virasoro, R., DeLong, JM., Estrella, RE., et al.[2022]

The Optilume urethral drug-coated balloon (DCB) treatment for recurrent anterior male urethral stricture is estimated to save the NHS £2502 per patient compared to current endoscopic management.

In a scenario analysis, Optilume also showed cost savings when compared to urethroplasty, with a savings of £243, indicating its potential as a cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture. Kelly, L., Shore, J., Wright, J., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39213367/

Long-Term Outcomes of Recurrent Bulbar Urethral ... Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty.

2. laborie.com laborie.com/blog/2025/01/17/optilume-drug-coated-balloon-shows-long-term-efficacy-for-urethral-strictures-five-year-data-published-in-the-journal-of-urology/

Optilume Five-Year Data Published in the Journal of Urology Optilume Drug-Coated Balloon Shows Long-Term Efficacy for Urethral Strictures: Five-Year Data Published in the Journal of Urology.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39712830/

Efficacy and Safety of Optilume Drug-Coated Balloon for ... These findings support Optilume DCB as a promising minimally invasive alternative to standard treatments, offering durable outcomes with a favorable safety ...

4. goldjournal.net goldjournal.net/article/S0090-4295(25)00708-3/fulltext

Efficacy of Drug-coated Balloon Dilation Versus ... One-year results for the ROBUST III randomized controlled trial evaluating the optilume(®) drug-coated balloon for anterior urethral strictures.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06827210

Treatment of Bulbar Urethral Strictures With Optilume Drug ... This study aims to provide robust evidence on the effectiveness of Optilume DCB in reducing stricture recurrence, improving patient outcomes, and offering a ...

6. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004229

Five-Year Results From the ROBUST I Study Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210020B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Optilume® DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi- ...

8. laborie.com laborie.com/blog/2025/05/08/optilume-stricture-3-year-data-from-robustiii/

Three-Year Data Confirms Optilume Long-Term Durability The study showed that 71.9% of patients treated with Optilume remained free from repeat intervention at three years, consistent with prior two-year data.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660187/

Efficacy and Safety of Optilume Drug-Coated Balloon for ... Recurrence and complication rates were generally low, with a high rate of freedom from re-intervention, indicating that the procedure is both safe and effective ...