Optilume Urethral DCB for Urethral Stricture

(STREAM Trial)

Recruiting at 5 trial locations

Overseen By Brenda Johnson, MS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for men with urethral stricture, a condition that narrows the urethra and can affect urination and semen quality. The treatment, called the Optilume Urethral Drug Coated Balloon (DCB), uses a special balloon with medicine to widen the urethra. Researchers aim to assess how this treatment impacts semen quality. Men diagnosed with a urethral stricture who meet certain health criteria, such as providing viable semen samples, might be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for the Optilume Urethral DCB?

Research shows that the Optilume Urethral Drug Coated Balloon (DCB) is generally easy for patients to handle. Studies have found it to be a safe choice for treating short urethral blockages in men. Many patients have experienced significant symptom improvements after treatment, indicating that the procedure works well without causing serious side effects.

Early results also confirm its safety. Various trials have tested the Optilume DCB, and patients usually experience few negative reactions. The FDA has already approved this treatment for certain types of urethral blockages, further supporting its safety for use in people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Optilume Urethral Drug Coated Balloon (DCB) is unique because it combines a mechanical and pharmaceutical approach to treat urethral strictures. Unlike traditional treatments like dilation or surgery, which primarily focus on physically opening the urethra, Optilume uses a balloon coated with paclitaxel, a drug that helps prevent scar tissue formation and restenosis. This dual-action method not only opens the narrowed area but also works to maintain the urethra's openness over time, potentially reducing the need for repeat procedures. Researchers are excited about this innovative approach because it addresses both the immediate and long-term challenges of urethral strictures.

What is the effectiveness track record for the Optilume Urethral DCB in treating urethral stricture?

Research shows that the Optilume Urethral Drug Coated Balloon (DCB), administered to participants in this trial, effectively treats urethral strictures, which are narrowings in the urethra that can block urine flow. Studies have found that this treatment significantly reduces symptoms and improves urination. Long-term evidence indicates it remains effective for at least five years after treatment. Optilume uses a balloon coated with paclitaxel, which releases into the urethral wall to help prevent the narrowing from returning. This treatment is already approved for urethral strictures, demonstrating its effectiveness in improving patient outcomes. ^{1 4 6 7 8}

Who Is on the Research Team?

Karl Coutinho, MD

Principal Investigator

New Jersey Urology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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® 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]

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 ... Key outcomes included significant reductions in symptom scores, as measured by the International Prostate Symptom Score (IPSS), and improvements ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Optilume® Urethral Drug Coated Balloon is used to treat patients with obstructive urinary symptoms associated with anterior urethral ...

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. laborie.com laborie.com/product/optilume-drug-coated-balloon-for-urethral-stricture-treatment/

Optilume® Urethral Drug Coated Balloon for the treatment ... It is designed to be used in adult males for urethral strictures of ≤3cm in length. The Optilume DCB is contraindicated for patients with known hypersensitivity ...

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

Efficacy and Safety of Optilume Drug-Coated Balloon for ... The analysis showed a statistically significant improvement in IPSS scores following Optilume DCB treatment, with a mean reduction of 13 points (95% CI: -15.8 ...

8. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.312

Optilume drug‐coated balloon for anterior urethral stricture: 2 ... Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who ...