Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT03195179

Collaborator

(none)

200

Enrollment

Location

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Fracture Urethra Tear Urethra Injury Male Trauma Surgery

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 Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Urethral obstruction [Through study completion, an average of 1 year]
Rates of urethral obstruction identified by urethrogram or cystoscopy

Secondary Outcome Measures

Treatment rate for urethral obstruction [Through study completion, an average of 1 year]
The rate of interventions for urethral obstruction after injury
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 - corporal splitting during urethroplasty [Through study completion, an average of 1 year]
The need to split the 2 corporal bodies
Urethroplasty complexity - total obstruction of the urethra during urethroplasty [Through study completion, an average of 1 year]
Finding the urethra was completely obstructed
Urethroplasty complexity - urethral diverticulum discovered during urethroplasty [Through study completion, an average of 1 year]
Finding a urethral diverticulum
Urethroplasty complexity - urethral fistula present [Through study completion, an average of 1 year]
Finding a urethral fistula
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
Urethroplasty complexity - total pubectomy during urethroplasty [Through study completion, an average of 1 year]
The need to remove the complete symphysis pubis
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 - medical treatment rates [Through study completion, an average of 1 year]
Measured by the need for pharmacologic treatment of erectile dysfunction
Erectile function - surgical treatment rates [Through study completion, an average of 1 year]
Rates of surgical treatment of erectile dysfunction
Incontinence [Through study completion, an average of 1 year]
Rates of surgical treatment of incontinence
Post-injury complications [3 month period post acute urethral injury]
Calvien-Dindo grading

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

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