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Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

NCT ID: NCT03195179

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Pelvic Fracture Urethra Tear Urethra Injury Male Trauma Surgery

Keywords

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pelvic fracture urethral injury urethra disruption trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Myers

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy Myers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00094160

Identifier Type: -

Identifier Source: org_study_id