Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft

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.

Conditions

• Urethral Stricture

Interventions

PROCEDURE

Urethroplasty with buccal mucosa graft

A surgery to correct urethral stricture

PROCEDURE

Ventral Buccal

Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra.

Sponsors & Collaborators

• University of Iowa

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Loyola University Chicago

  collaborator OTHER

• Lahey Clinic

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Washington

  collaborator OTHER

• New York University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of Minnesota

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-01

Primary Completion

2019-03-01

Completion

2019-03-01

Countries

• United States

Study Locations