Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury (PREvsSPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03468387|
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : May 1, 2018
It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding:
- The success rate after initial intervention.
- The need for urethroplasty in the failed realignment group and cystostomy group.
- The success rate of urethroplasty in the failed realignment group and cystostomy group.
|Condition or disease||Intervention/treatment||Phase|
|Urethral Injury||Procedure: Primary realignment Procedure: Suprapubic cystostomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
|Active Comparator: Primary realignment||
Procedure: Primary realignment
Endoscopic realignment of rupture urethra over a urethral catheter
|Active Comparator: Suprapubic cystostomy||
Procedure: Suprapubic cystostomy
Percutaneous cystostomy catheter will be inserted under sonographic guidance
- The success rate after initial intervention (realignment or suprapubic cystostomy). [ Time Frame: 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
- The success rate of urethroplasty in both groups. [ Time Frame: 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. [ Time Frame: 3 months after initial intervention ]Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.