A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
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.
1. Screening for eligibility; Enrollment/baseline: Patients are referred to UCSF urology
 clinic for urethroplasty. Participants commonly come to the clinic having already had
 imaging of their stricture, completed the appropriate PROMs, uroflowmetry and post-void
 residual urine volume measurement. The patient usually leaves the initial clinic visit
 with a scheduled surgery. Thus, both screening and enrollment will be done at the
 initial clinic visit. If the patient agrees to enroll and signs the consent form, they
 will then be randomized.

 2. Randomization: The PI will contact the research assistant by email or telephone and
 communicate the random identification number of the subject and receive the random
 assignment to ventral or dorsal graft. This will usually occur after the initial clinic
 visit but certainly before the surgery date. Patients will not be blinded as to their
 assignment. Surgeons, out of necessity, will not be blinded as well.

 3. Treatment/intervention period: Patient will undergo urethroplasty using standard
 approach and graft will be placed ventrally or dorsally, as assigned. Most patients go
 home the same day after surgery. A catheter will be left in the urethra for 2-4 weeks as
 is standard approach for buccal graft urethroplasties.

 4. Follow-up (there will be no extra clinic visits, questionnaires, or tests beyond that
 which the investigators normally do for all patients undergoing urethroplasty):

 1. 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture
 line

 2. 3 and 12 months post-operative clinic visit:

 i. cystoscopy ii. PROMs and additional post-operative questionnaires iii. Uroflowmetry
 and post-void residual urine volume c. Annual visits after year 1: The investigators
 will typically follow patients annually with no end date after urethroplasty. For
 publication purposesits has been set to 1 year as the study end date but the
 investigators will continue to see the patients outside the study protocol after year 1
 (so that participants receive the same care as people not in the study) and will perform
 the following: i. Cystoscopy, if indicated based on abnormalities in ii or iii ii. PROMs
 and additional post-operative questionnaires iii. Uroflowmetry and post-void residual
 urine volume

 5. Data Safety and Monitoring Both ventral and dorsal buccal mucosa graft are standard of
 care and all surgeons in this study have performed at least 50-100 of each of these
 surgeries. Investigators do not anticipate adverse events that are not well known in the
 literature. Urethroplasty is generally a low risk surgery. Still, any AEs will be
 monitored by the surgeon and communicated to Dr. Jeremy Myers at The University of Utah,
 which serves as the coordinating center for this study.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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