Surgery Clinical Trial
Official title:
The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
NCT number | NCT03195179 |
Other study ID # | 00094160 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | August 31, 2021 |
Verified date | October 2021 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urethral obstruction | Rates of urethral obstruction identified by urethrogram or cystoscopy | Through study completion, an average of 1 year | |
Secondary | Treatment rate for urethral obstruction | The rate of interventions for urethral obstruction after injury | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - gap length during urethroplasty | The gap between the 2 severed ends of the urethra | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - bulbar mobilization length during urethroplasty | The length of bulbar mobilization | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - corporal splitting during urethroplasty | The need to split the 2 corporal bodies | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - total obstruction of the urethra during urethroplasty | Finding the urethra was completely obstructed | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - urethral diverticulum discovered during urethroplasty | Finding a urethral diverticulum | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - urethral fistula present | Finding a urethral fistula | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - inferior pubectomy during urethroplasty | The need to remove the inferior portion of the symphysis pubis | Through study completion, an average of 1 year | |
Secondary | Urethroplasty complexity - total pubectomy during urethroplasty | The need to remove the complete symphysis pubis | Through study completion, an average of 1 year | |
Secondary | Erectile function- SHIM score | Erectile function measured by the Sexual Health Inventory for Men (SHIM) | Through study completion, an average of 1 year | |
Secondary | Erectile function - medical treatment rates | Measured by the need for pharmacologic treatment of erectile dysfunction | Through study completion, an average of 1 year | |
Secondary | Erectile function - surgical treatment rates | Rates of surgical treatment of erectile dysfunction | Through study completion, an average of 1 year | |
Secondary | Incontinence | Rates of surgical treatment of incontinence | Through study completion, an average of 1 year | |
Secondary | Post-injury complications | Calvien-Dindo grading | 3 month period post acute urethral injury |
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