Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Study Overview
=================
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.

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

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

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suprapubic tube placement<br>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. | |
| Urethral realignment<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral obstruction | Rates of urethral obstruction identified by urethrogram or cystoscopy | Through study completion, an average of 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic fracture urethral injury, urethra, disruption, trauma