## Protocol Section
### Identification Module
**NCT ID:** NCT03195179

**Brief Title:** Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

**Official Title:** The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

#### Organization Study ID Info
**ID:** 00094160
#### Organization
**Class:** OTHER
**Full Name:** University of Utah
### Status Module
#### Completion Date
**Date:** 2021-08-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-10-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-10-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-31

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01-01

**Type:** ACTUAL

**Status Verified Date:** 2021-10

#### Study First Post Date
**Date:** 2017-06-22
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-16
**Study First Submit QC Date:** 2017-06-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Utah

#### Responsible Party

**Investigator Affiliation:** University of Utah

**Investigator Full Name:** Jeremy Myers

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Pelvic Fracture

- Urethra Tear

- Urethra Injury Male

- Trauma

- Surgery

**Keywords:**

- pelvic fracture urethral injury

- urethra

- disruption

- trauma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** Suprapubic tube placement

#### Arm Group 2

**Description:** 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.

**Label:** Urethral realignment

### Outcomes Module

#### Primary Outcomes

**Description:** Rates of urethral obstruction identified by urethrogram or cystoscopy

**Measure:** Urethral obstruction

**Time Frame:** Through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** The rate of interventions for urethral obstruction after injury

**Measure:** Treatment rate for urethral obstruction

**Time Frame:** Through study completion, an average of 1 year

**Description:** The gap between the 2 severed ends of the urethra

**Measure:** Urethroplasty complexity - gap length during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** The length of bulbar mobilization

**Measure:** Urethroplasty complexity - bulbar mobilization length during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** The need to split the 2 corporal bodies

**Measure:** Urethroplasty complexity - corporal splitting during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** Finding the urethra was completely obstructed

**Measure:** Urethroplasty complexity - total obstruction of the urethra during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** Finding a urethral diverticulum

**Measure:** Urethroplasty complexity - urethral diverticulum discovered during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** Finding a urethral fistula

**Measure:** Urethroplasty complexity - urethral fistula present

**Time Frame:** Through study completion, an average of 1 year

**Description:** The need to remove the inferior portion of the symphysis pubis

**Measure:** Urethroplasty complexity - inferior pubectomy during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** The need to remove the complete symphysis pubis

**Measure:** Urethroplasty complexity - total pubectomy during urethroplasty

**Time Frame:** Through study completion, an average of 1 year

**Description:** Erectile function measured by the Sexual Health Inventory for Men (SHIM)

**Measure:** Erectile function- SHIM score

**Time Frame:** Through study completion, an average of 1 year

**Description:** Measured by the need for pharmacologic treatment of erectile dysfunction

**Measure:** Erectile function - medical treatment rates

**Time Frame:** Through study completion, an average of 1 year

**Description:** Rates of surgical treatment of erectile dysfunction

**Measure:** Erectile function - surgical treatment rates

**Time Frame:** Through study completion, an average of 1 year

**Description:** Rates of surgical treatment of incontinence

**Measure:** Incontinence

**Time Frame:** Through study completion, an average of 1 year

**Description:** Calvien-Dindo grading

**Measure:** Post-injury complications

**Time Frame:** 3 month period post acute urethral injury

### Eligibility Module

**Eligibility 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

**Gender Based:** True

**Gender 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Salt Lake City

**Country:** United States

**Facility:** University of Utah

**State:** Utah

**Zip:** 84132

#### Overall Officials

**Official 1:**

**Affiliation:** University of Utah

**Name:** Jeremy Myers, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005264

- Term: Femoral Fractures

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M9696

- Name: Hip Fractures

- Relevance: HIGH

- As Found: Pelvic Fracture

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000050723

- Term: Fractures, Bone

- ID: D000006620

- Term: Hip Fractures

### Misc Info Module

- Version Holder: 2024-05-24
