Skip to main content
OpenTrials
Completed

NCT Number: NCT03195179

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 retrospective record review should determine the utility of acute urethral realignment after PFUI.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Surgery Trauma Urethra Injury Male Urethra Tear Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urethral obstruction

    Time frame: Through study completion, an average of 1 year

    Rates of urethral obstruction identified by urethrogram or cystoscopy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2017
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.