Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft (NCT02551783) | Clinical Trial Compass
TerminatedNot Applicable
Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft
Stopped: Failure to recruit
United States150 participantsStarted 2015-09-01
Plain-language summary
This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of repairing the strictured urethra. Current evidence suggests the two approaches for placement of the graft are equally successful at correcting the stricture and the two approaches have similar risks of complications. The investigators propose to randomly assign appropriately selected patients to either a dorsally- or ventrally-placed graft. No additional procedures beyond the normal care protocol will be required of the patients. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.
Who can participate
Age range
18 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Strictures must predominantly include the proximal and/or mid bulbar urethra and be otherwise amenable to buccal graft onlay urethroplasty
* Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra within the scrotum, but not through the scrotum to the pendulous junction
* Subjects able to consent for themselves
Exclusion Criteria:
* prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter placement, male urethral sling placement, and rectourethral fistula
* radiation therapy to the pelvis
* previous hypospadias repair
* lichen sclerosis unable to consent for themselves
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Incidence of anatomic recurrence determined by cystoscopy