Optilume for Ureteral Stricture

(ENDURE1 Trial)

Recruiting at 1 trial location

Overseen By Reem Ennenga

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Urotronic Inc.

Must not be taking: Paclitaxel, Antiplatelets, Anticoagulants

Disqualifiers: Chronic renal failure, Uncontrolled diabetes, Active infection, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Optilume treatment, a medical device, to determine its safety and effectiveness for individuals with a narrowed ureter, the tube carrying urine from the kidney to the bladder. The goal is to see if this new treatment can open a blocked ureter. The trial seeks participants with a single narrowed area in their ureter that is 4 cm or shorter and who have two functioning kidneys. Individuals with this condition who have not undergone recent procedures on the ureter may qualify for the study. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could enhance treatment options for ureteral narrowing.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you can't stop taking antiplatelet or anticoagulation medications before treatment. Also, you should not be on medications that negatively interact with paclitaxel.

What prior data suggests that the Optilume device is safe for treating ureteric strictures?

Studies have shown that Optilume is generally safe and well-tolerated. One study found a low complication rate of 9.5%, with most side effects being mild and temporary. This indicates that any problems experienced were usually not serious and didn't last long. Other research confirms that Optilume is a safe choice for some men with urethral strictures who want to avoid more invasive surgery. This treatment has been used successfully for urethral issues, with many not needing further procedures for up to three years. These findings suggest that Optilume can be a reliable option with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Optilume is unique because it introduces a novel approach to treating ureteral stricture with a combination of mechanical dilation and drug delivery. Unlike traditional treatments that might rely on repeated surgeries or stents, Optilume uses a balloon coated with a drug that aims to reduce scar tissue formation while dilating the ureter. Researchers are excited about this treatment because it could potentially offer a less invasive, more effective solution with longer-lasting results compared to current options.

What evidence suggests that Optilume is effective for ureteric strictures?

Studies have shown that Optilume effectively treats urethral strictures. One study demonstrated an improvement in maximum urinary flow rate from 5.0 mL/s to 19.9 mL/s after using Optilume, along with a significant decrease in residual urine in the bladder. Long-term research indicates that Optilume reduces the need for repeated procedures and maintains symptom relief for at least three years. Specifically, 62.8% of patients did not experience a recurrence of their condition after treatment with Optilume. These findings suggest that Optilume could be a promising option for managing urethral strictures. ^{4 6 7 8 9}

Who Is on the Research Team?

Jamie Landman, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single ureteric or uretero-enteric stricture that's less than or equal to 4 cm long. Participants must have two functioning kidneys.

Inclusion Criteria

Both of my kidneys are working.

I have a single narrow area in my ureter or where my ureter connects to my intestine that is 4.0 cm long or shorter.

I am 18 years old or older.

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 Drug-Coated Balloon for ureteric stricture

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Optilume

Trial Overview The trial is testing the safety and effectiveness of Optilume, a drug-coated balloon, in treating narrowings (strictures) within the tubes connecting the kidney to the bladder (ureters).

How Is the Trial Designed?

Group I: Optilume Experimental Treatment 1 Intervention

Treatment with Optilume for ureteric stricture

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39213367/

Long-Term Outcomes of Recurrent Bulbar Urethral ... Maximum urinary flow rate improved from 5.0 mL/s at baseline to 19.9 (P < .01), and average postvoid residual was reduced from 141.4 mL to 59.5 ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S009042952501012X

Early real-world experience with Optilume® drug-coated ... Anterior Urethral Stricture Recurrence. A total of 96 patients (37.2%) experienced any recurrence after DCB, of which 18 (19.1%) had a ...

4. urologytimes.com urologytimes.com/view/long-term-data-point-to-durable-efficacy-of-optilume-for-urethral-strictures

Long-term data point to durable efficacy of Optilume for ... Optilume DCB shows significant symptom improvement and reduced reintervention rates in urethral stricture disease over three years, with a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06827210

Treatment of Bulbar Urethral Strictures With Optilume Drug ... "The primary outcome is the proportion of participants who remain free from repeat intervention for urethral stricture recurrence at 12 months following ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39712830/

Efficacy and Safety of Optilume Drug-Coated Balloon for ... The complication rate, calculated as a weighted average across studies, was low at 9.5%, with most adverse events being mild and temporary, ...

7. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004229

Five-Year Results From the ROBUST I Study Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty.

8. laborie.com laborie.com/blog/2025/05/08/optilume-stricture-3-year-data-from-robustiii/

Three-Year Data Confirms Optilume Long-Term Durability The study showed that 71.9% of patients treated with Optilume remained free from repeat intervention at three years, consistent with prior two-year data.

9. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-025-01896-3

Optilume, a minimally invasive solution for BPH and urethral ... In Robust I, 12 months, anatomic success was achieved in 70% of the 53 males with < 12Fr, <2 cm anterior urethral stricture with 2-year ...