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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03195179
Enrollment
200
Registered
2017-06-22
Start date
2016-01-01
Completion date
2021-08-31
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Fracture, Surgery, Trauma, Urethra Injury Male, Urethra Tear

Keywords

pelvic fracture urethral injury, urethra, disruption, trauma

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.

Interventions

None listed

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Urethral obstructionThrough study completion, an average of 1 yearRates of urethral obstruction identified by urethrogram or cystoscopy

Secondary

MeasureTime frameDescription
Urethroplasty complexity - gap length during urethroplastyThrough study completion, an average of 1 yearThe gap between the 2 severed ends of the urethra
Urethroplasty complexity - bulbar mobilization length during urethroplastyThrough study completion, an average of 1 yearThe length of bulbar mobilization
Urethroplasty complexity - corporal splitting during urethroplastyThrough study completion, an average of 1 yearThe need to split the 2 corporal bodies
Urethroplasty complexity - total obstruction of the urethra during urethroplastyThrough study completion, an average of 1 yearFinding the urethra was completely obstructed
Urethroplasty complexity - urethral diverticulum discovered during urethroplastyThrough study completion, an average of 1 yearFinding a urethral diverticulum
Urethroplasty complexity - urethral fistula presentThrough study completion, an average of 1 yearFinding a urethral fistula
Treatment rate for urethral obstructionThrough study completion, an average of 1 yearThe rate of interventions for urethral obstruction after injury
Urethroplasty complexity - total pubectomy during urethroplastyThrough study completion, an average of 1 yearThe need to remove the complete symphysis pubis
Erectile function- SHIM scoreThrough study completion, an average of 1 yearErectile function measured by the Sexual Health Inventory for Men (SHIM)
Erectile function - medical treatment ratesThrough study completion, an average of 1 yearMeasured by the need for pharmacologic treatment of erectile dysfunction
Erectile function - surgical treatment ratesThrough study completion, an average of 1 yearRates of surgical treatment of erectile dysfunction
IncontinenceThrough study completion, an average of 1 yearRates of surgical treatment of incontinence
Post-injury complications3 month period post acute urethral injuryCalvien-Dindo grading
Urethroplasty complexity - inferior pubectomy during urethroplastyThrough study completion, an average of 1 yearThe need to remove the inferior portion of the symphysis pubis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026