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Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

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ClinicalTrials.gov Identifier: NCT03195179
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jeremy Myers, University of Utah

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 proposed prospective multi-institutional cohort study should determine the utility of acute urethral realignment after PFUI.


Condition or disease
Pelvic Fracture Urethra Tear Urethra Injury Male Trauma Surgery

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Suprapubic tube placement
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.
Urethral realignment
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.



Primary Outcome Measures :
  1. Urethral obstruction [ Time Frame: Through study completion, an average of 1 year ]
    Rates of urethral obstruction identified by urethrogram or cystoscopy


Secondary Outcome Measures :
  1. Treatment rate for urethral obstruction [ Time Frame: Through study completion, an average of 1 year ]
    The rate of interventions for urethral obstruction after injury

  2. Urethroplasty complexity - gap length during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    The gap between the 2 severed ends of the urethra

  3. Urethroplasty complexity - bulbar mobilization length during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    The length of bulbar mobilization

  4. Urethroplasty complexity - corporal splitting during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    The need to split the 2 corporal bodies

  5. Urethroplasty complexity - total obstruction of the urethra during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    Finding the urethra was completely obstructed

  6. Urethroplasty complexity - urethral diverticulum discovered during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    Finding a urethral diverticulum

  7. Urethroplasty complexity - urethral fistula present [ Time Frame: Through study completion, an average of 1 year ]
    Finding a urethral fistula

  8. Urethroplasty complexity - inferior pubectomy during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    The need to remove the inferior portion of the symphysis pubis

  9. Urethroplasty complexity - total pubectomy during urethroplasty [ Time Frame: Through study completion, an average of 1 year ]
    The need to remove the complete symphysis pubis

  10. Erectile function- SHIM score [ Time Frame: Through study completion, an average of 1 year ]
    Erectile function measured by the Sexual Health Inventory for Men (SHIM)

  11. Erectile function - medical treatment rates [ Time Frame: Through study completion, an average of 1 year ]
    Measured by the need for pharmacologic treatment of erectile dysfunction

  12. Erectile function - surgical treatment rates [ Time Frame: Through study completion, an average of 1 year ]
    Rates of surgical treatment of erectile dysfunction

  13. Incontinence [ Time Frame: Through study completion, an average of 1 year ]
    Rates of surgical treatment of incontinence

  14. Post-injury complications [ Time Frame: 3 month period post acute urethral injury ]
    Calvien-Dindo grading



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pelvic fracture urethral injuries are only treated by this method in men. Female urethral injuries are very rare and most often treated with immediate surgical repair.
Sampling Method:   Non-Probability Sample
Study Population
Men experiencing a traumatic pelvic fracture urethral injury where there is a major urethral disruption that prevents passage of a catheter or a retrograde cystoscope.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195179


Contacts
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Contact: Elizabeth Lignell, BA 801-213-2780 elizabeth.lignell@hsc.utah.edu
Contact: Jeremy Myers, MD 810-213-2700 jeremybmyers@gmail.com

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Elizabeth Lignell, BA    801-213-2780    Elizabeth.lignell@hsc.utah.edu   
Contact: Jeremy Myers, MD    801-213-2700    jeremybmyers@gmail.com   
Principal Investigator: Jeremy Myers, MD, FACS         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Jeremy Myers, MD University of Utah

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Responsible Party: Jeremy Myers, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03195179     History of Changes
Other Study ID Numbers: 00094160
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Myers, University of Utah:
pelvic fracture urethral injury
urethra
disruption
trauma
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries