Clinical trial NCT03195179: Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
Official title: The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Fracture
Urethra Tear
Urethra Injury Male
Trauma
Surgery
Keywords: pelvic fracture urethral injury
urethra
disruption
trauma
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urethral obstruction
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Treatment rate for urethral obstruction
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - gap length during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - bulbar mobilization length during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - corporal splitting during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - total obstruction of the urethra during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - urethral diverticulum discovered during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - urethral fistula present
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - inferior pubectomy during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Urethroplasty complexity - total pubectomy during urethroplasty
timeFrame: Through study completion, an average of 1 year
measure: Erectile function- SHIM score
timeFrame: Through study completion, an average of 1 year
measure: Erectile function - medical treatment rates
timeFrame: Through study completion, an average of 1 year
measure: Erectile function - surgical treatment rates
timeFrame: Through study completion, an average of 1 year
measure: Incontinence
timeFrame: Through study completion, an average of 1 year
measure: Post-injury complications
timeFrame: 3 month period post acute urethral injury
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jeremy Myers, MD
role: PRINCIPAL_INVESTIGATOR
References: