Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men experiencing a traumatic pelvic fracture urethral injury where there is a major urethral disruption that prevents passage of a catheter or a retrograde cystoscope.

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Suprapubic tube placement; Standard of care management for men with complete urethral injuries where a Foley catheter fails to be placed will have a suprapubic tube placed to manage the acute urethral injury. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes.
Urethral realignment; Standard of care management for men with complete urethral injuries where a Foley catheter fails to be placed will undergo urethral realignment with a combined antegrade / retrograde approach within 7 days of injury. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethral obstruction	Rates of urethral obstruction identified by urethrogram or cystoscopy	Through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Jeremy Myers, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: trauma; pelvic fracture urethral injury; urethra; disruption
• Additional Relevant MeSH Terms: Leg Injuries; Femoral Fractures; Hip Injuries; Wounds and Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 00094160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No