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

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.

Conditions

• Urethral Stricture

Interventions

PROCEDURE

Ventral buccal mucosa onlay urethroplasty

Ventral buccal graft onlay involves a midline perineal incision and retraction of the bulbospongiosum muscle downward to expose the ventral urethral surface. The corpus spongiosum is incised longitudinally to expose the urethral lumen and the incision is extended proximal and distal to the established stricture. The buccal mucosa graft is harvested and trimmed to the length and width of the urethrotomy and the graft is sutured at the proximal and distal apices and a running suture at the lateral margins to establish a tight anastomosis. Ventral placement allows for limited urethral mobilization and easy access, but there is concern about higher likelihood of diverticulum formation and development of other associated complications - such as post void dribbling and ejaculatory dysfunction.

PROCEDURE

Dorsal buccal mucosa onlay urethroplasty

Dorsal buccal onlay also involves a midline perineal incision. The bulbo-cavernosum and corpora cavernosum are dissected from the bulbar urethra allowing for complete mobilization of the urethra. The urethra is rotated 180 degrees to allow for dorsal access and an incision is made on the dorsal urethra proximal and distal to the stricture location. The buccal graft is harvested and trimmed to the appropriate size of the urethrotomy and spread on the overlying tunica albuginea of the corporal bodies. The urethra is rotated back to allow for suturing of the left mucosal margin to the left margin of the buccal graft and corporal bodies, essentially covering the entire urethral plate. Dorsal placement has potential for a more stable vascular bed for graft sustainability and less spongiosal bleeding, but requires a greater urethral mobilization and longer operative times.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Central Ohio Urology Group

  collaborator OTHER

• Loyola University Chicago

  collaborator OTHER

• Lahey Clinic

  collaborator OTHER

• University of Washington

  collaborator OTHER

• New York University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• benjamin n breyer, MD, MAS, FAC · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2018-11-30

Completion

2018-11-30

Countries

• United States

Study Locations