A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
Stopped early · Not applicable
Conditions studied: Urethral Stricture
In brief
The investigators propose 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 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.
Key facts
- Study ID
- NCT02634619
- Run by
- University of California, San Francisco
- People needed
- 95
- Starts
- 2016-06-01
- Expected to finish
- 2018-11-01
- Last updated by the study team
- 2019-04-25
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male ≥ 18 years old with diagnosis of bulbar urethral stricture by voiding cystourethrogram of known and/or idiopathic etiology.
- Male patients with bulbar urethral stricture > 1 cm in length
- Strictures must predominantly include the proximal and/or mid-bulbar urethra
- Strictures may extend from the mid-bulbar urethra into the distal bulbar urethra
You may not qualify if…
- Patients with prior history of open urethral surgery, such as:
- Prior urethroplasty
- Artificial urniary Sphincter placement
- Male urethral sling placement
- Rectourethral fistula
- Radiation therapy to the abdomen or pelvis
- Patients with previous hypospadias repair
- lichen sclerosis
- no involvement of the pendulous urethra
Where it is running
- University of California San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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