Pelvic FractureNCT03195179
Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
An observational study of Pelvic Fracture and Urethra Tear, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pelvic Fracture, Urethra Tear, Urethra Injury Male
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcomes of 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.
Read the detailed description
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.
- Conditions
- Pelvic Fracture, Urethra Tear, Urethra Injury Male, Trauma, Surgery
- Keywords
- pelvic fracture urethral injury, urethra, disruption, trauma
- Medical subject headings
- Hip Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suprapubic tube placement | Standard of care management for 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. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes. | |
| Urethral realignment | Standard of care management for 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. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral obstruction
Rates of urethral obstruction identified by urethrogram or cystoscopy
Measured: Through study completion, an average of 1 year
Secondary outcomes (14)
Treatment rate for urethral obstruction
The rate of interventions for urethral obstruction after injury
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - gap length during urethroplasty
The gap between the 2 severed ends of the urethra
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - bulbar mobilization length during urethroplasty
The length of bulbar mobilization
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - corporal splitting during urethroplasty
The need to split the 2 corporal bodies
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - total obstruction of the urethra during urethroplasty
Finding the urethra was completely obstructed
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - urethral diverticulum discovered during urethroplasty
Finding a urethral diverticulum
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - urethral fistula present
Finding a urethral fistula
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - inferior pubectomy during urethroplasty
The need to remove the inferior portion of the symphysis pubis
Measured: Through study completion, an average of 1 year
Urethroplasty complexity - total pubectomy during urethroplasty
The need to remove the complete symphysis pubis
Measured: Through study completion, an average of 1 year
Erectile function- SHIM score
Erectile function measured by the Sexual Health Inventory for Men (SHIM)
Measured: Through study completion, an average of 1 year
Erectile function - medical treatment rates
Measured by the need for pharmacologic treatment of erectile dysfunction
Measured: Through study completion, an average of 1 year
Erectile function - surgical treatment rates
Rates of surgical treatment of erectile dysfunction
Measured: Through study completion, an average of 1 year
Incontinence
Rates of surgical treatment of incontinence
Measured: Through study completion, an average of 1 year
Post-injury complications
Calvien-Dindo grading
Measured: 3 month period post acute urethral injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Jan 2016
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Myers, University of Utah
- Investigators
- Jeremy Myers, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195179
- Sponsor's protocol ID
- 00094160
- Status last verified
- Oct 2021
- First submitted
- 16 Jun 2017
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury
- ClinicalTrials.gov ID
- NCT03195179
- Acronym / sponsor ID
- 00094160
- Conditions
- Pelvic Fracture, Urethra Tear, Urethra Injury Male, Trauma, Surgery
- Keywords
- pelvic fracture urethral injury, urethra, disruption, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapubic tube placement | – | –Standard of care management for 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. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes. |
| Urethral realignment | – | –Standard of care management for 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. This is a standard of care approach and a retrospective review will be done on the patient record to determine outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urethral obstruction
Time frame: Through study completion, an average of 1 year
Rates of urethral obstruction identified by urethrogram or cystoscopy
14 secondary outcomes
Treatment rate for urethral obstruction
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - gap length during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - bulbar mobilization length during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - corporal splitting during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - total obstruction of the urethra during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - urethral diverticulum discovered during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - urethral fistula present
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - inferior pubectomy during urethroplasty
Time frame: Through study completion, an average of 1 year
Urethroplasty complexity - total pubectomy during urethroplasty
Time frame: Through study completion, an average of 1 year
Erectile function- SHIM score
Time frame: Through study completion, an average of 1 year
Erectile function - medical treatment rates
Time frame: Through study completion, an average of 1 year
Erectile function - surgical treatment rates
Time frame: Through study completion, an average of 1 year
Incontinence
Time frame: Through study completion, an average of 1 year
Post-injury complications
Time frame: 3 month period post acute urethral injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Myers, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture and Urethra Tear, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethral obstruction (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.