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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ROBUST-III Trial Summary
This trial will test the safety and effectiveness of a new balloon device to treat bowel 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.Check my eligibility
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.See study design
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.
ROBUST-III 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've had 2 or more treatments for urethral stricture but no surgery.
Select...
I am a man aged 18 or older.
Select...
I have a urethral stricture that is 3.0 cm or shorter.
ROBUST-III Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Subjects Stricture Free
Safety: Rate of Major Device or Procedure Related Complications
Secondary outcome measures
Change in Qmax (Peak Flow Rate)
IPSS Percent Responder (50% Improvement in IPSS Score)
ROBUST-III 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.
Find a Location
Who is running the clinical trial?
Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
805 Total Patients Enrolled
4 Trials studying Urethral Stricture
103 Patients Enrolled for Urethral Stricture
ClinLogix. LLCIndustry Sponsor
10 Previous Clinical Trials
1,578 Total Patients Enrolled
Sean Elliott, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Urethral Stricture
16 Patients Enrolled for Urethral Stricture
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an artificial device in my urinary system.I am allergic to TAXOL, on conflicting medication, or have low neutrophil counts.I have been diagnosed with Lichen Sclerosus or have a stricture from BXO.You have a condition that makes it hard to talk to the study doctor about the study or to fill out the study questionnaires.I have prostate issues making catheter use difficult.I have had or might have a kidney or bladder stone pass in the last or next 6 weeks.The doctor needs to visually confirm a narrowing in the urinary tract using a special camera or x-ray test.I have been diagnosed with untreated BPH or bladder neck contracture.My medication doses for certain conditions have been stable for the last 6 months.I was diagnosed with cancer in my urethra, bladder, or prostate in the last 2 years.I have chronic kidney failure and am receiving hemodialysis.My diabetes is not under control, or it affects my wound healing.Your International Prostate Symptoms Score (IPSS) is 11 or higher. If you have a suprapubic catheter, it's assumed to be a score of 35 or higher.I agree to use protection during sex for 30 days after treatment.I have an active infection in my urinary system.I have blood in my urine not caused by a benign or untreated condition.I experience frequent urination, pain, urgency, blood in urine, slow flow, feeling of incomplete emptying, or recurrent UTIs.I experience difficulty urinating that my doctor does not believe is due to a stricture.I've had 2 or more treatments for urethral stricture but no surgery.I have known issues with bladder control or muscle function.I have had cancer outside the urinary system that is not fully in remission, except for skin cancer.I agree to use protection or abstain from sex for 90 days after treatment.I rely on Botox for urinary system issues.Your urine flow rate is less than 15 milliliters per second, or you have a suprapubic catheter.I have not received treatment for stress urinary incontinence.I am a man aged 18 or older.Blood in your urine that doesn't have a known cause.I have been diagnosed with bladder inflammation due to radiation.I have had surgery on the front part of my urethra.I have had surgery to correct hypospadias.You have had a suprapubic catheter for more than three months before joining the study.I had a procedure to widen a narrow part of my body, not including using a catheter, within the last 6 weeks.I was diagnosed with an overactive bladder less than 6 months ago.I am not currently in a study for an unapproved drug or device, but follow-up for an approved one is okay.My stricture is longer than 3.0 cm.I have a neurological condition like MS or Parkinson's affecting my bladder.I have a urethral stricture that is 3.0 cm or shorter.Your urethra is too narrow, with a diameter of 12 French units or less.A thin wire must be able to pass through the blockage in the blood vessel.
Research Study Groups:
This trial has the following groups:- Group 1: Optilume Treatment
- Group 2: Control 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.
What are the various locales where this experiment is operational?
"This experiment is being conducted across 25 different sites, most notably Western New york Urology Associates in Cheektowaga, New York; Mayo Clinic in Rochester, Minnesota; and Integrated Medical Professionals OBP in North Hills, Virginia."
Answered by AI
Are there any current opportunities to participate in this clinical trial?
"According to clinicaltrials.gov, this research is not currently recruiting subjects and was last updated on June 2nd 2021. Despite the lack of open recruitment at present, there are an additional 225 studies that are still actively enrolling patients right now."
Answered by AI
Who else is applying?
What site did they apply to?
Advanced Urology Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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