Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury

Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03468387

Acronym

PREvsSPC

Enrollment

Registered

2018-03-16

Start date

2018-06-01

Completion date

2021-06-01

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Injury

Brief summary

It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding: 1. The success rate after initial intervention. 2. The need for urethroplasty in the failed realignment group and cystostomy group. 3. The success rate of urethroplasty in the failed realignment group and cystostomy group.

Interventions

PROCEDUREPrimary realignment

Endoscopic realignment of rupture urethra over a urethral catheter

PROCEDURESuprapubic cystostomy

Percutaneous cystostomy catheter will be inserted under sonographic guidance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Male children less than 18 years presenting with pelvic fracture urethral injury

Exclusion criteria

* Associated bladder neck injury. * Associated rectal injury. * Late presentation \>2weeks since trauma. * History of previous urethral intervention.

Design outcomes

Primary

Measure	Time frame	Description
The success rate after initial intervention (realignment or suprapubic cystostomy).	3 months after initial intervention.	The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram

Secondary

Measure	Time frame	Description
The success rate of urethroplasty in both groups.	3 months after urethroplasty.	The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.
The need for urethroplasty in both groups.	3 months after initial intervention	Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026