Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Completed

• Conditions: Urethra Tear; Pelvic Fracture; Surgery; Urethra Injury Male; Trauma

• Registration Number: NCT03195179
• Lead Sponsor: University of Utah

Brief Summary

Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial urethral realignment after PFUI decreases rates of urethral obstruction and the need for subsequent urethral procedures.

The retrospective record review should determine the utility of acute urethral realignment after PFUI.

Detailed Description

A retrospective chart review to compare outcomes between urethral realignment (group 1) and suprapubic tube (SPT) placement (group 2). The comparison will be between two routinely practiced management approaches of urethral injury after pelvic fracture.

Prior studies demonstrate urethral realignment is associated with a 15% to 50% reduction in urethral obstruction, however, it has also been associated with higher rates of incontinence and erectile dysfunction. Our hypothesis is that early realignment of traumatic urethral injuries after pelvic fracture lowers the incidence of complications like urethral strictures and subsequent need for surgeries.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Men > 18 years old Blunt force trauma Presence of pelvic fracture Urethral injury Inability to pass a Foley catheter retrograde through the injury into the bladder

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Exclusion Criteria

Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urethral obstruction	Through study completion, an average of 1 year	Rates of urethral obstruction identified by urethrogram or cystoscopy

Secondary Outcome Measures

Name	Time	Method
Urethroplasty complexity - corporal splitting during urethroplasty	Through study completion, an average of 1 year	The need to split the 2 corporal bodies
Urethroplasty complexity - gap length during urethroplasty	Through study completion, an average of 1 year	The gap between the 2 severed ends of the urethra
Urethroplasty complexity - bulbar mobilization length during urethroplasty	Through study completion, an average of 1 year	The length of bulbar mobilization
Urethroplasty complexity - urethral fistula present	Through study completion, an average of 1 year	Finding a urethral fistula
Urethroplasty complexity - total obstruction of the urethra during urethroplasty	Through study completion, an average of 1 year	Finding the urethra was completely obstructed
Treatment rate for urethral obstruction	Through study completion, an average of 1 year	The rate of interventions for urethral obstruction after injury
Urethroplasty complexity - total pubectomy during urethroplasty	Through study completion, an average of 1 year	The need to remove the complete symphysis pubis
Urethroplasty complexity - inferior pubectomy during urethroplasty	Through study completion, an average of 1 year	The need to remove the inferior portion of the symphysis pubis
Erectile function - medical treatment rates	Through study completion, an average of 1 year	Measured by the need for pharmacologic treatment of erectile dysfunction
Urethroplasty complexity - urethral diverticulum discovered during urethroplasty	Through study completion, an average of 1 year	Finding a urethral diverticulum
Erectile function- SHIM score	Through study completion, an average of 1 year	Erectile function measured by the Sexual Health Inventory for Men (SHIM)
Erectile function - surgical treatment rates	Through study completion, an average of 1 year	Rates of surgical treatment of erectile dysfunction
Post-injury complications	3 month period post acute urethral injury	Calvien-Dindo grading
Incontinence	Through study completion, an average of 1 year	Rates of surgical treatment of incontinence

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States