Optilume Urethral DCB for Urethral Stricture

(STREAM Trial)

Recruiting at 7 trial locations

Overseen By Reem Ennenga

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Urotronic Inc.

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

Disqualifiers: Paclitaxel allergy, Vasectomy, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1 day

34 Participants Needed

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.

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

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 European Union, United States, Canada for the following indications:

Approved in European Union as Optilume Urethral Drug Coated Balloon for:

• Anterior urethral strictures

Approved in United States as Optilume Urethral Drug Coated Balloon for:

• Anterior urethral strictures

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

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]

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 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]

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]