Urethral InjuryPREvsSPCNCT03468387
Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury
A study testing Primary realignment and Suprapubic cystostomy in people with Urethral Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years, men only
- Conditions the study is for
- Urethral Injury
- What is being tested?
- Primary realignment and Suprapubic cystostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Jun 2021
- Phase
- Interventional
- 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 1 year to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male children less than 18 years presenting with pelvic fracture urethral injury
Who cannot join
- Associated bladder neck injury.
- Associated rectal injury.
- Late presentation >2weeks since trauma.
- History of previous urethral intervention.
About this study
Official title: Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
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.
- Conditions
- Urethral Injury
- Being tested
- Primary realignment, Suprapubic cystostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary realignmentProcedure or surgery
Endoscopic realignment of rupture urethra over a urethral catheter
Suprapubic cystostomyProcedure or surgery
Percutaneous cystostomy catheter will be inserted under sonographic guidance
| Study group | Role | What they receive |
|---|---|---|
| Primary realignment | Active comparator | Not described Receives: Procedure: Primary realignment |
| Suprapubic cystostomy | Active comparator | Not described Receives: Procedure: Suprapubic cystostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate after initial intervention (realignment or suprapubic cystostomy).
The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram
Measured: 3 months after initial intervention.
Secondary outcomes (2)
The success rate of urethroplasty in both groups.
The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.
Measured: 3 months after urethroplasty.
The need for urethroplasty in both groups.
Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.
Measured: 3 months after initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468387
- Sponsor's protocol ID
- URSP
- Acronym
- PREvsSPC
- Status last verified
- Apr 2018
- First submitted
- 6 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03468387
- Acronym / sponsor ID
- PREvsSPC / URSP
- Conditions
- Urethral Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 16 Mar 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary realignment | Active comparator | Procedure: Primary realignment |
| Suprapubic cystostomy | Active comparator | Procedure: Suprapubic cystostomy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male children less than 18 years presenting with pelvic fracture urethral injury
Key exclusion criteria (4 listed)
- Associated bladder neck injury.
- Associated rectal injury.
- Late presentation >2weeks since trauma.
- History of previous urethral intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary realignmentEndoscopic realignment of rupture urethra over a urethral catheter | Procedure or surgery | Primary realignment |
| Suprapubic cystostomyPercutaneous cystostomy catheter will be inserted under sonographic guidance | Procedure or surgery | Suprapubic cystostomy |
Primary outcome
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
2 secondary outcomes
The success rate of urethroplasty in both groups.
Time frame: 3 months after urethroplasty.
The need for urethroplasty in both groups.
Time frame: 3 months after initial intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Primary realignment and Suprapubic cystostomy in people with Urethral Injury, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The success rate after initial intervention (realignment or suprapubic cystostomy). (time frame: 3 months after initial intervention.). 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 1 May 2018.