What side effects are associated with this type of intervention?

Common treatments for urethral stricture, such as dilation, urethrotomy, and urethroplasty, can have side effects including bleeding, infection, pain, and recurrence of the stricture. Local drug delivery systems like the Optilume Urethral DCB, which are designed to deliver medication directly to the stricture site, may also cause localized side effects such as irritation, inflammation, and discomfort at the application site. Systemic side effects are generally minimal due to the localized nature of the treatment.

What prior FDA approvals exist?

The FDA has approved various treatments for urethral stricture, though specific approvals for local drug delivery systems like the Optilume Urethral DCB are not detailed. Traditional treatments include surgical options such as urethrotomy and urethroplasty. Additionally, some studies have explored the use of drugs like captopril and docetaxel in animal models for their potential benefits in managing urethral strictures. These treatments aim to reduce fibrosis and improve urethral patency, similar to the goals of the Optilume Urethral DCB trial.

What other types of research exist?

Promising novel alternatives to Optilume Urethral DCB for treating urethral strictures include: 1) Drug-coated balloons (DCBs) with different pharmacological agents, 2) Biodegradable stents that gradually release medication, 3) Regenerative medicine approaches such as stem cell therapy, and 4) Minimally invasive laser treatments. These alternatives are being explored for their potential to improve outcomes and reduce recurrence rates in urethral stricture patients.

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Procedure

Optilume Urethral DCB for Urethral Stricture (STREAM Trial)

Phase 4

Recruiting

Led By Karl Coutinho, MD

Research Sponsored by Urotronic Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use

Male subjects between 22 and 65 years of age

Must not have

Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential

Subject is unwilling to abstain or utilize a condom for 30 days after the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for Optilume Urethral DCB, similar procedures may cause discomfort at the treatment site, urinary issues like infection or retention, and potential impact on sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a man aged between 22 and 65.

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I am a man aged between 22 and 55.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am unwilling to abstain from sex or use a condom for 30 days after the procedure.

Select...

I have a history of cancer that is not fully in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Safety Endpoint

Secondary study objectives

Secondary Safety Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Optilume Urethral DCBExperimental Treatment1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Optilume Urethral DCB (Drug-Coated Balloon) is a treatment for urethral stricture that combines mechanical dilation with local drug delivery. The balloon physically dilates the narrowed urethral segment, while the drug coating, typically an antiproliferative agent, is released to inhibit scar tissue formation and reduce the risk of restenosis. This dual-action approach is significant for urethral stricture patients as it addresses both the immediate obstruction and the underlying cause of stricture recurrence, potentially improving long-term outcomes and reducing the need for repeated interventions.

The effect of halofuginone, an inhibitor of collagen type i synthesis, on urethral stricture formation: in vivo and in vitro study in a rat model.