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Drug Coated Balloon
Drug Coated Balloon for Urethral Stricture (ROBUST-II 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 UTI's (urinary tract infections).
Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
ROBUST-II Trial Summary
This trial is designed to see if a new balloon device is safe and effective for treating urethral stricture.
Who is the study for?
Men over 18 with urethral stricture, experiencing symptoms like frequent urination or slow flow. They must have had at least two prior treatments for the condition but no urethroplasty, and a confirmed narrow passage in the urethra. Excluded are those with strictures from untreated infections, previous radiation, certain bladder issues, sensitivity to paclitaxel, or recent procedures on the stricture.Check my eligibility
What is being tested?
The trial is evaluating a Drug Coated Balloon (DCB) device's safety and performance for treating men with urethral stricture disease. The DCB is designed to reopen narrowed passages without surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort during treatment, urinary tract infection risk increase due to intervention in the urinary system, possible allergic reactions if sensitive to components such as paclitaxel.
ROBUST-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience frequent urination, pain, urgency, blood in urine, slow flow, feeling of incomplete emptying, or recurrent UTIs.
Select...
I experience frequent urination, pain, urgency, blood in urine, slow flow, or feel like I can't fully empty my bladder.
Select...
I am a man aged 18 or older.
Select...
I have a blockage in my urethra that is 3 cm or shorter.
ROBUST-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety- Rate of Device Related Serious Complications
Secondary outcome measures
Efficacy- Stricture Recurrence Rate
Safety- Change in IIEF (International Index of Erectile Function)
ROBUST-II Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urotronic Drug Coated Balloon (DCB)
2016
Completed Early Phase 1
~60
Find a Location
Who is running the clinical trial?
Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
916 Total Patients Enrolled
4 Trials studying Urethral Stricture
214 Patients Enrolled for Urethral Stricture
Sean Elliott, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Urethral Stricture
127 Patients Enrolled for Urethral Stricture
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience frequent urination, pain, urgency, blood in urine, slow flow, feeling of incomplete emptying, or recurrent UTIs.I have had 2 or more treatments for urethral stricture but no urethroplasty.I have had radiation therapy to my pelvic area before.I experience frequent urination, pain, urgency, blood in urine, slow flow, or feel like I can't fully empty my bladder.You have a score of 13 or higher on the IPSS test, which measures prostate symptom severity.I am allergic to paclitaxel or on medication that interacts with it.I have had surgery on the front part of my urethra.I have a narrowing in my urethra caused by a past bacterial infection or untreated gonorrhea.You have blockages in your body that are longer than 3.0 cm.A doctor has seen a narrow or blocked passage in your urinary system using a special camera.I have a history of overactive bladder or stress incontinence.I have had kidney or bladder stones, or passed stones in the last 6 months.Your urethra is narrower than 12 French units when tested with a urethrogram.The tool used to guide the treatment must be able to pass through the blockage.I have known issues with bladder control or muscle function.Your maximum urine flow rate is less than 12 milliliters per second.I am a man aged 18 or older.You have a medical device in your urinary tract or prostate.I had a procedure to widen or cut a narrowed area in my body within the last 3 months.I have a blockage in my urethra that is 3 cm or shorter.I have more than one narrowing in my body's tubes.You have a catheter placed in your lower abdomen.I have had surgery to remove my prostate gland.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different medical sites are offering this clinical experiment?
"This trial is enrolling patients from various locations, including University of Iowa in Iowa City and Chesapeake Urology located in Hanover, Maryland. Another two sites are the University of Minnesota in Minneapolis and five other medical centres."
Answered by AI
Is enrollment currently open for this experiment?
"According to records on clinicaltrials.gov, this medical trial is not actively searching for participants currently. The study was initially posted in October of 2017 and last updated November 21st 2022. However, at present there are 225 other trials that are accepting patients into their studies."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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