Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial primary urethral realignment (PR) after PFUI decreases the incidence of urethral obstruction and the need for subsequent urethral procedures. We present methodology for a prospective cohort study analyzing the outcomes of PR versus suprapubic cystostomy tube (SPT) after PFUI.
A prospective cohort trial was designed to compare outcomes between PR (group 1) and 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 cystoscopy exam is done to confirm a complete urethral disruption and attempt at gentle retrograde catheter placement. If catheter placement fails, group 1 will undergo urethral realignment and group 2 will undergo SPT. The primary outcome measure will be the rate of urethral obstruction preventing atraumatic passage of a flexible cystoscope. Secondary outcome measures include: subsequent urethral interventions, post-injury complications, urethroplasty complexity, erectile dysfunction (ED) and urinary incontinence rates.
Prior studies demonstrate PR is associated with a 15% to 50% reduction in urethral obstruction. 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). Busy trauma centers treat complete PFUI approximately 1-6 times per year, thus our goal is to recruit 25 trauma centers and enroll patients for 3 years with a goal of 100 or more total patients with complete urethral disruption.
The proposed prospective multi-institutional cohort study should determine the utility of acute urethral realignment after PFUI.
Translational andrology and urology. 2018 Aug [Epub]
Rachel A Moses, John Patrick Selph, Bryan B Voelzke, Joshua Piotrowski, Jairam R Eswara, Bradley A Erickson, Shubham Gupta, Roger R Dmochowski, Niels V Johnsen, Anand Shridharani, Sarah D Blaschko, Sean P Elliott, Ian Schwartz, Catherine R Harris, Kristy Borawski, Bradley D Figler, E Charles Osterberg, Frank N Burks, William Bihrle, Brandi Miller, Richard A Santucci, Benjamin N Breyer, Brian Flynn, Ty Higuchi, Fernando J Kim, Joshua A Broghammer, Angela P Presson, Jeremy B Myers, from the Trauma and Urologic Reconstruction Network of Surgeons (TURNS)
Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USA., Department of Urology, University of Alabama at Birmingham, Birmingham, AL, USA., Department of Urology, Harborview Medical Center, University of Washington, Seattle, WA, USA., Department of Urology, Medical College of Wisconsin, Milwaukee, WI, USA., Division of Urology, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA., Department of Urology, University of Iowa, Iowa City, IA, USA., Department of Urology, University of Kentucky, Lexington, KY, USA., Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA., Department of Urology, University of Tennessee College of Medicine, Chattanooga, TN, USA., Division of Urology, Alameda Health System, Oakland, CA, USA., Division of Urology, Department of Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USA., Santa Clara Valley Medical Center, San Jose, CA, USA., Department of Urology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA., Department of Surgery, University of Texas, Dell Medical School, Austin, TX, USA., Department of Urology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA., Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Department of Urology, Detroit Medical Center, Detroit, MI, USA., Department of Urology, University of California-San Francisco, San Francisco, CA, USA., Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USA., Department of Urology, University of Kansas Medical Center, Kansas City, Kansas, USA.