Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Surgery Clinical Trial

Official title:

The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195179
• Other study ID #: 00094160
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pelvic Fracture
• Surgery
• Trauma
• Urethra Injury Male
• Urethra Tear
• Wounds and Injuries

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