- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195179
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urethral obstruction
Time Frame: Through study completion, an average of 1 year
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Rates of urethral obstruction identified by urethrogram or cystoscopy
|
Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment rate for urethral obstruction
Time Frame: Through study completion, an average of 1 year
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The rate of interventions for urethral obstruction after injury
|
Through study completion, an average of 1 year
|
Urethroplasty complexity - gap length during urethroplasty
Time Frame: Through study completion, an average of 1 year
|
The gap between the 2 severed ends of the urethra
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Through study completion, an average of 1 year
|
Urethroplasty complexity - bulbar mobilization length during urethroplasty
Time Frame: Through study completion, an average of 1 year
|
The length of bulbar mobilization
|
Through study completion, an average of 1 year
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Urethroplasty complexity - corporal splitting during urethroplasty
Time Frame: Through study completion, an average of 1 year
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The need to split the 2 corporal bodies
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Through study completion, an average of 1 year
|
Urethroplasty complexity - total obstruction of the urethra during urethroplasty
Time Frame: Through study completion, an average of 1 year
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Finding the urethra was completely obstructed
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Through study completion, an average of 1 year
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Urethroplasty complexity - urethral diverticulum discovered during urethroplasty
Time Frame: Through study completion, an average of 1 year
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Finding a urethral diverticulum
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Through study completion, an average of 1 year
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Urethroplasty complexity - urethral fistula present
Time Frame: Through study completion, an average of 1 year
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Finding a urethral fistula
|
Through study completion, an average of 1 year
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Urethroplasty complexity - inferior pubectomy during urethroplasty
Time Frame: Through study completion, an average of 1 year
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The need to remove the inferior portion of the symphysis pubis
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Through study completion, an average of 1 year
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Urethroplasty complexity - total pubectomy during urethroplasty
Time Frame: Through study completion, an average of 1 year
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The need to remove the complete symphysis pubis
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Through study completion, an average of 1 year
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Erectile function- SHIM score
Time Frame: Through study completion, an average of 1 year
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Erectile function measured by the Sexual Health Inventory for Men (SHIM)
|
Through study completion, an average of 1 year
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Erectile function - medical treatment rates
Time Frame: Through study completion, an average of 1 year
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Measured by the need for pharmacologic treatment of erectile dysfunction
|
Through study completion, an average of 1 year
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Erectile function - surgical treatment rates
Time Frame: Through study completion, an average of 1 year
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Rates of surgical treatment of erectile dysfunction
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Through study completion, an average of 1 year
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Incontinence
Time Frame: Through study completion, an average of 1 year
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Rates of surgical treatment of incontinence
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Through study completion, an average of 1 year
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Post-injury complications
Time Frame: 3 month period post acute urethral injury
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Calvien-Dindo grading
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3 month period post acute urethral injury
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeremy Myers, MD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00094160
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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