Journal article
An American Association for the Surgery of Trauma (AAST) prospective multi-center research protocol: outcomes of urethral realignment versus suprapubic cystostomy after pelvic fracture urethral injury
Translational andrology and urology, Vol.7(4), pp.512-520
08/2018
DOI: 10.21037/tau.2017.11.07
PMCID: PMC6127553
PMID: 30211041
Abstract
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.
Details
- Title: Subtitle
- An American Association for the Surgery of Trauma (AAST) prospective multi-center research protocol: outcomes of urethral realignment versus suprapubic cystostomy after pelvic fracture urethral injury
- Creators
- Rachel A Moses - Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USAJohn Patrick Selph - Department of Urology, University of Alabama at Birmingham, Birmingham, AL, USABryan B Voelzke - Department of Urology, Harborview Medical Center, University of Washington, Seattle, WA, USAJoshua Piotrowski - Department of Urology, Medical College of Wisconsin, Milwaukee, WI, USAJairam R Eswara - Division of Urology, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USABradley A Erickson - Department of Urology, University of Iowa, Iowa City, IA, USAShubham Gupta - Department of Urology, University of Kentucky, Lexington, KY, USARoger R Dmochowski - Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USANiels V Johnsen - Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USAAnand Shridharani - Department of Urology, University of Tennessee College of Medicine, Chattanooga, TN, USASarah D Blaschko - Division of Urology, Alameda Health System, Oakland, CA, USASean P Elliott - Division of Urology, Department of Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USAIan Schwartz - Division of Urology, Department of Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USACatherine R Harris - Santa Clara Valley Medical Center, San Jose, CA, USAKristy Borawski - Department of Urology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USABradley D Figler - Department of Urology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USAE Charles Osterberg III - Department of Surgery, University of Texas, Dell Medical School, Austin, TX, USAFrank N Burks - Department of Urology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USAWilliam Bihrle III - Dartmouth Hitchcock Medical Center, Lebanon, NH, USABrandi Miller - Department of Urology, Detroit Medical Center, Detroit, MI, USARichard A Santucci - Department of Urology, Detroit Medical Center, Detroit, MI, USABenjamin N Breyer - Department of Urology, University of California-San Francisco, San Francisco, CA, USABrian Flynn - Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USATy Higuchi - Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USAFernando J Kim - Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USAJoshua A Broghammer - Department of Urology, University of Kansas Medical Center, Kansas City, Kansas, USAAngela P Presson - Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USAJeremy B Myers - Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USA
- Resource Type
- Journal article
- Publication Details
- Translational andrology and urology, Vol.7(4), pp.512-520
- DOI
- 10.21037/tau.2017.11.07
- PMID
- 30211041
- PMCID
- PMC6127553
- NLM abbreviation
- Transl Androl Urol
- ISSN
- 2223-4691
- eISSN
- 2223-4691
- Publisher
- China
- Language
- English
- Date published
- 08/2018
- Academic Unit
- Urology
- Record Identifier
- 9984051578102771
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