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Surgical Techniques for Urethral Stricture (VeSpAR Trial)
N/A
Waitlist Available
Research Sponsored by University Hospital, Ghent
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 12, and 24 months
Awards & highlights
VeSpAR Trial Summary
This trial is comparing two surgical techniques for treating urethral strictures. They want to see if one method leads to less erectile dysfunction than the other.
Who is the study for?
Men over 18 with a specific short (up to 3cm) blockage in the tube that carries urine out of the body (bulbar urethral stricture), confirmed by certain medical imaging or procedures. Participants must be able to attend follow-up visits and provide written consent. Those with multiple strictures, longer strictures, other health risks, or who cannot commit to follow-ups are excluded.Check my eligibility
What is being tested?
The trial is comparing two surgical methods for repairing a narrow section of the bulbar urethra: one that cuts through and rejoins it (tAR) versus one that tries to preserve nearby blood vessels (vsAR). The goal is to see if vsAR has similar success rates but causes less erectile dysfunction than tAR.See study design
What are the potential side effects?
Potential side effects from these surgeries may include pain at the surgery site, difficulty urinating, infection risk, bleeding complications, and possibly temporary or permanent issues with sexual function.
VeSpAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 12, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FFS at 24 months
Secondary outcome measures
Ejaculatory function
Erectile function
FFS at 3 and 12 months
+7 moreVeSpAR Trial Design
2Treatment groups
Active Control
Group I: Vessel-sparing anastomotic repair (vsAR)Active Control1 Intervention
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
Group II: Transecting anastomotic repair (tAR)Active Control1 Intervention
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
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Who is running the clinical trial?
University Hospital, GhentLead Sponsor
703 Previous Clinical Trials
152,521 Total Patients Enrolled
6 Trials studying Urethral Stricture
1,450 Patients Enrolled for Urethral Stricture
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a narrowing in your urethra that is 3 centimeters or smaller.You have a short bulbar urethral stricture that is confirmed by certain medical tests.You have a narrow or blocked urethra in a specific part.You have a narrow or blocked urethra.People who are transgenderYou are not healthy enough for surgery.You have strictures in other parts of the urethra, like the penile urethra, membranous urethra, prostatic urethra, or bladder neck.You have urethral strictures longer than 3 centimeters.You have a blockage in your urethra at any location other than the urethra opening.You have strictures related to lichen sclerosus.You have narrow passages in the urinary tract after surgery for hypospadias.You have a condition called neurogenic bladder.You have had to have a different surgical technique for urethral repair for any reason.You have received radiation treatment in the pelvic area in the past.You are currently taking medication or receiving treatment to improve erectile function.
Research Study Groups:
This trial has the following groups:- Group 1: Vessel-sparing anastomotic repair (vsAR)
- Group 2: Transecting anastomotic repair (tAR)
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 is the current accession rate for this experiment?
"Yes, according to the clinicaltrials.gov website, this medical examination is currently in search of volunteers. The trial was initially posted on September 26th 2018 and most recently updated on March 28th 2022. Approximately 100 participants are needed between 2 different sites for enrollment."
Answered by AI
Is there still opportunity to participate in this experiment?
"Affirmative, as indicated on clinicaltrials.gov this research is still enrolling patients. It was initially published in September 2018 and amended most recently on March 28th 2022. The investigators are looking for 100 volunteers from 2 medical centres to partake in the trial."
Answered by AI
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