Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | January 1, 2016 |
| End Date: | December 31, 2019 |
| Contact: | Elizabeth Lignell, BA |
| Email: | elizabeth.lignell@hsc.utah.edu |
| Phone: | 801-213-2780 |
The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
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 proposed prospective multi-institutional cohort study should determine the utility of
acute urethral realignment after PFUI.
controversial whether initial urethral realignment after PFUI decreases rates of urethral
obstruction and the need for subsequent urethral procedures.
The proposed prospective multi-institutional cohort study should determine the utility of
acute urethral realignment after PFUI.
A prospective cohort trial was designed to compare outcomes between urethral realignment
(group 1) and suprapubic tube (SPT) placement (group 2). Centers are assigned to a group upon
entry into the study. All patients will undergo retrograde attempted catheter placement; if
this fails a cystoscopic exam is done to confirm a complete urethral disruption. If catheter
placement fails, group 1 will undergo urethral realignment and group 2 will undergo SPT.
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. Ninety-six men (48 per treatment group) are required to detect a
15% treatment effect (80% power, 0.05 significance level, 20% loss to follow up / death
rate). 100 patients will be enrolled with complete PFUI.
(group 1) and suprapubic tube (SPT) placement (group 2). Centers are assigned to a group upon
entry into the study. All patients will undergo retrograde attempted catheter placement; if
this fails a cystoscopic exam is done to confirm a complete urethral disruption. If catheter
placement fails, group 1 will undergo urethral realignment and group 2 will undergo SPT.
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. Ninety-six men (48 per treatment group) are required to detect a
15% treatment effect (80% power, 0.05 significance level, 20% loss to follow up / death
rate). 100 patients will be enrolled with complete PFUI.
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
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Jeremy Myers, MD, FACS
Phone: 801-213-2780
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