Drug Coated Balloon for Urethral Stricture

(ROBUST-III Trial)

Recruiting at 21 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

127 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Optilume Stricture Drug Coated Balloon. It helps patients with narrowings in their urinary tract by inflating to open up the area and releasing medication to keep it open. The study will involve a number of patients to see if this device is safe and effective. Previous studies have shown promising results in treating recurrent urethral strictures.

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 data supports the effectiveness of the Optilume drug-coated balloon treatment for urethral stricture?

The ROBUST I and III studies show that the Optilume drug-coated balloon, which combines mechanical widening of the urethra with a drug to keep it open, is effective in treating recurrent urethral strictures, providing both immediate relief and long-term benefits. ^{1 2 3 4 5}

How is the Optilume drug-coated balloon treatment different from other treatments for urethral stricture?

The Optilume drug-coated balloon is unique because it combines mechanical dilation to immediately relieve symptoms with a paclitaxel coating that helps keep the urethra open longer by delivering medication directly to the site. This approach aims to reduce the high recurrence rates seen with traditional treatments like endoscopic management. ^{1 2 3 4 5}

Research Team

Sean Elliott, MD

Principal Investigator

University of Minnesota

Ramon Virasoro, MD

Principal Investigator

US Department of Veterans Affairs

Eligibility Criteria

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.

I have been diagnosed with Lichen Sclerosus or have a stricture from BXO.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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® 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 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]

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™ 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. [2021]