Optilume Urethral DCB for Urethral Stricture

(STREAM Trial)

Recruiting at7 trial locations

Overseen by Karl Coutinho, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Urotronic Inc.

Must not be taking: 5-alpha reductase, Alpha-blockers, SSRIs, Hormone therapy

Disqualifiers: Paclitaxel allergy, Vasectomy, Cancer, others

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a device that opens up blockages in the urine tube and releases a drug to keep it open. It targets adult men with these blockages. The study will check how well it works and if it affects semen quality.

Will I have to stop taking my current medications?

If you are currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy, you will need to stop taking them for a certain period before joining the trial. The protocol mentions a 'washout' period, which means a time without taking these medications.

What data supports the effectiveness of the Optilume Urethral Drug Coated Balloon treatment for urethral stricture?

Research from the ROBUST I and III studies shows that the Optilume drug-coated balloon, which combines a balloon to open the urethra and a drug to keep it open, is effective in treating urethral strictures, with results showing reduced recurrence rates compared to traditional methods. ^{1 2 3 4 5}

How is the Optilume Urethral DCB treatment different from other treatments for urethral stricture?

The Optilume Urethral DCB 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, reducing the chance of the stricture coming back. ^{1 2 3 4 5}

Research Team

Karl Coutinho, MD

Principal Investigator

New Jersey Urology

Eligibility Criteria

Men aged 22-65 with urethral stricture and healthy semen parameters (concentration, motility, volume) who can consent to follow-ups. Excluded are those with vasectomies, hypersensitivity to paclitaxel, certain medication use without washout period, unwillingness to abstain or use condoms post-procedure, or a history of cancer not in remission.

Inclusion Criteria

You have at least 39 million sperm in total.

I have a narrow spot in my urethra that can be treated with a specific procedure.

I am a man aged between 22 and 65.

Exclusion Criteria

I agree to use effective birth control for 6 months after the procedure.

You are allergic to paclitaxel or similar drugs.

I have had a vasectomy or a condition affecting sperm production.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Optilume Urethral DCB

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of semen quality, LUTS, sexual function, and voiding function

12 months

Visits at 30 days, 3 months, 6 months, and 12 months post-treatment

Extended Follow-up

Additional assessments for subjects with abnormal semen quality at 6 months, continuing periodically until results return to normal

Indefinite, based on individual recovery

Treatment Details

Interventions

• Optilume Urethral DCB (Procedure)

Trial Overview The study is testing the Optilume Urethral Drug-Coated Balloon (DCB) on men with urethral strictures. It's a single-arm trial focusing on how this treatment affects semen quality after the procedure.

Participant Groups

Group I: Optilume Urethral DCB Experimental Treatment 1 Intervention

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.

Optilume Urethral DCB is already approved in Canada for the following indications:

Approved in Canada as Optilume Urethral Drug Coated Balloon for:

• Anterior urethral strictures

Who Is Running the Clinical Trial?

Urotronic Inc.

Lead Sponsor

Trials

10

Recruited

1,400+

Laborie Medical Technologies Inc.

Industry Sponsor

Trials

15

Recruited

1,100+

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™ 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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Canada pubmed.ncbi.nlm.nih.gov

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

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

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

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

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