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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195179
Other study ID # 00094160
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date August 31, 2021

Study information

Verified date October 2021
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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