What side effects are associated with this type of intervention?

Common treatments for urethral stricture, such as physical dilation and drug-mediated inhibition of cellular proliferation, have several known side effects. Physical dilation can cause bleeding, infection, and recurrence of the stricture. Drug-coated balloons, which aim to prevent restenosis by inhibiting cellular proliferation, may lead to local irritation, allergic reactions, and potential systemic side effects depending on the specific drug used.

What prior FDA approvals exist?

The FDA has approved various treatments for urethral stricture, primarily focusing on physical dilation methods and drug-mediated approaches to inhibit cellular proliferation. One notable example is the use of drug-coated balloons, which combine mechanical dilation with localized drug delivery to prevent restenosis. The Optilume Stricture Drug Coated Balloon, currently under study in the ROBUST III trial, exemplifies this approach by using a balloon coated with a drug to inhibit cellular proliferation, thereby maintaining urethral patency. While specific prior FDA approvals for similar drug-coated devices are limited, the concept aligns with existing strategies in vascular interventions, such as paclitaxel-coated balloons used in peripheral artery disease.

What other types of research exist?

Promising alternatives to the Optilume Stricture Drug Coated Balloon for urethral stricture treatment in 2024 include: 1) Endoscopic balloon dilation combined with local drug delivery systems, such as paclitaxel-coated balloons, which have shown efficacy in preventing restenosis. 2) Minimally invasive surgical techniques like endoscopic urethrotomy with adjunctive use of mitomycin C to reduce recurrence rates. 3) Regenerative medicine approaches, including the use of stem cell therapy and tissue engineering to promote urethral healing and reduce stricture formation.

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Drug Coated Balloon for Urethral Stricture (ROBUST-III Trial)

N/A

Waitlist Available

Led By Sean Elliott, MD

Research Sponsored by Urotronic Inc.

Eligibility Criteria Checklist

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

Must have

Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's)

Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty

Must not have

Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate

Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified in the provided information. However, as with any medical procedure involving drug-coated devices, there may be risks such as local irritation, allergic reaction to the medication on the balloon, or infection.

Eligibility Criteria

Inclusion Criteria

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

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I experience frequent urination, pain, urgency, blood in urine, slow flow, feeling of incomplete emptying, or recurrent UTIs.

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I've had 2 or more treatments for urethral stricture but no surgery.

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I am a man aged 18 or older.

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I have a urethral stricture that is 3.0 cm or shorter.

Exclusion Criteria

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

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I have an artificial device in my urinary system.

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

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I have prostate issues making catheter use difficult.

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I have been diagnosed with untreated BPH or bladder neck contracture.

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I have chronic kidney failure and am receiving hemodialysis.

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My diabetes is not under control, or it affects my wound healing.

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I have an active infection in my urinary system.

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I have known issues with bladder control or muscle function.

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I have had cancer outside the urinary system that is not fully in remission, except for skin cancer.

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I rely on Botox for urinary system issues.

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I have not received treatment for stress urinary incontinence.

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I have been diagnosed with bladder inflammation due to radiation.

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I have had surgery on the front part of my urethra.

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I have had surgery to correct hypospadias.

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I had a procedure to widen a narrow part of my body, not including using a catheter, within the last 6 weeks.

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My stricture is longer than 3.0 cm.

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I have a neurological condition like MS or Parkinson's affecting my bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Percentage of Subjects Stricture Free

Safety: Rate of Major Device or Procedure Related Complications

Secondary study objectives

Change in Qmax (Peak Flow Rate)

IPSS Percent Responder (50% Improvement in IPSS Score)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Optilume TreatmentExperimental Treatment1 Intervention

The treatment arm will be the Urotronic Optilume Drug Coated Balloon (DCB).

Group II: Control TreatmentActive Control1 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.

0 / 21Eligibility 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

Common treatments for urethral stricture include physical dilation and drug-mediated inhibition of cellular proliferation. Physical dilation mechanically widens the narrowed urethral segment to restore normal urine flow. Drug-mediated treatments, such as those studied with the Optilume Stricture Drug Coated Balloon, aim to prevent recurrence by inhibiting cellular proliferation and fibrous tissue formation. This dual approach is crucial for patients as it provides immediate relief and reduces the likelihood of stricture recurrence, improving long-term outcomes.

[Pirfenidone alleviates urethral stricture following urethral injury in rats by suppressing TGF-β1 signaling and inflammatory response].Docetaxel inhibits urethral stricture formation, an initial study in rabbit model.Combination histamine and serotonin treatment after simulated childbirth injury improves stress urinary incontinence.