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

NCT02551783 | Terminated

• 1 other identifier: 1508M77183
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

urethral stricture; urethroplasty; buccal mucosa; graft

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of anatomic recurrence determined by cystoscopy

  Anatomic evidence of recurrence based on surveillance cystoscopy (i.e., if the 16F flexible cystoscope cannot bypass the surgical site then there is a failure). Flexible cystoscopy will be performed at 3 and 12 months after surgery. All surgeons will use a standard-sized scope. This will be a bivariate outcome (scope is able to pass without trauma vs. unable to pass or only able to pass with trauma)

  1 year

Secondary Outcomes (1)

• Cumulative Incidence of Complications deep venous incision and drainage

  2 years

Other Outcomes (9)

• Cumulative Incidence of Secondary Procedures to Treat Stricture Recurrence restenosis

  2 years

• Urinary Symptoms

  2 years

• Symptoms, Other pain in the penis and leakage of urine.

  2 years

Study Arms (2)

Urethroplasty with buccal mucosa graft

EXPERIMENTAL

Intervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the dorsal wall of the urethra.

Procedure: Urethroplasty with buccal mucosa graft

Ventral Buccal

ACTIVE COMPARATOR

Intervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra.

Procedure: Ventral Buccal

Interventions

Urethroplasty with buccal mucosa graft PROCEDURE

A surgery to correct urethral stricture

Urethroplasty with buccal mucosa graft

Ventral Buccal PROCEDURE

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

Ventral Buccal

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Strictures must predominantly include the proximal and/or mid bulbar urethra and be otherwise amenable to buccal graft onlay urethroplasty
• Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra within the scrotum, but not through the scrotum to the pendulous junction
• Subjects able to consent for themselves

You may not qualify if:

• prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter placement, male urethral sling placement, and rectourethral fistula
• radiation therapy to the pelvis
• previous hypospadias repair
• lichen sclerosis unable to consent for themselves

Sponsors & Collaborators

• University of Minnesota: lead
• University of Iowa: collaborator
• University of Kansas: collaborator
• Ohio State University: collaborator
• University of Utah: collaborator
• Loyola University Chicago: collaborator
• Lahey Clinic: collaborator
• University of California, San Francisco: collaborator
• University of Washington: collaborator
• New York University: collaborator
• University of California, San Diego: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)