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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California
study started

Description

Summary

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.

Official Title

A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty

Details

  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):
  5. 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture line
  6. 3 and 12 months post-operative clinic visit:
  7. 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
  8. 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.

Keywords

Urethral Stricture Constriction, Pathologic

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California San Francisco accepting new patients
    San Francisco, California, 94143, United States

Details

Status
accepting new patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT02634619
Lead Scientist
Benjamin Breyer
Study Type
Interventional
Last Updated
July 2016
I’m interested in this study!