Pediatric DisorderNCT05087537
Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve
A study testing Valve ablation and Valve ablation and bladder neck incision in people with Pediatric Disorder and Hydronephrosis in Children, run by Mansoura University at 1 site in Egypt.
Trial summary
To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve. Read more about this study
- Who is it for?
- Ages Up to 12 years, men only
- Conditions the study is for
- Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary
- What is being tested?
- Valve ablation and Valve ablation and bladder neck incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Jan 2023
- 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 Up to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Patients who are less than 12 years of age with presenting to the Mansoura University Urology and Nephrology Center with the diagnosis of PUV will be s creended for eligibility
Who cannot join
- Patients with other conditions that can potentially affect lower and upper urinary tract functions
- Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
- Patients who had primary treatment of posterior urethral valve ablation at other hospitals.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center, Mansoura university
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve : A Randomized Controlled Trial
To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.
- Conditions
- Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary, Hydronephrosis Congenital, Bladder-Neck; Obstruction, Congenital, Urethral Valve
- Being tested
- Valve ablation, Valve ablation and bladder neck incision
- Keywords
- PUV, BNI, Urethral valve, Valve ablation, Bladder dysfunction
- Medical subject headings
- Hydronephrosis, Neoplasm Metastasis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve ablationProcedure or surgery
Valve ablation
Valve ablation and bladder neck incisionProcedure or surgery
Valve ablation and bladder neck incision
| Study group | Role | What they receive |
|---|---|---|
| Valve ablation | Active comparator | Valve ablation Receives: Procedure: Valve ablation |
| Valve ablation and bladder neck incision | Active comparator | Valve ablation and bladder neck incision Receives: Procedure: Valve ablation and bladder neck incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare numbers of reintervention between groups
assessed by calculating the number of patients needed surgical reintervention per total number of patients in both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087537
- Sponsor's protocol ID
- PUV , BNI
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 25 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05087537
- Acronym / sponsor ID
- PUV , BNI
- Conditions
- Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary, Hydronephrosis Congenital, Bladder-Neck; Obstruction, Congenital, Urethral Valve
- Keywords
- PUV, BNI, Urethral valve, Valve ablation, Bladder dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Oct 2021 (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.
To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valve ablation | Active comparator | Procedure: Valve ablationValve ablation |
| Valve ablation and bladder neck incision | Active comparator | Procedure: Valve ablation and bladder neck incisionValve ablation and bladder neck incision |
Who may qualify
- Ages
- Up to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who are less than 12 years of age with presenting to the Mansoura University Urology and Nephrology Center with the diagnosis of PUV will be s creended for eligibility
Key exclusion criteria (3 listed)
- Patients with other conditions that can potentially affect lower and upper urinary tract functions
- Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
- Patients who had primary treatment of posterior urethral valve ablation at other hospitals.
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 |
|---|---|---|
| Valve ablationValve ablation | Procedure or surgery | Valve ablation |
| Valve ablation and bladder neck incisionValve ablation and bladder neck incision | Procedure or surgery | Valve ablation and bladder neck incision |
Primary outcome
compare numbers of reintervention between groups
Time frame: 1 year
assessed by calculating the number of patients needed surgical reintervention per total number of patients in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valve ablation and Valve ablation and bladder neck incision in people with Pediatric Disorder and Hydronephrosis in Children, run by Mansoura University at 1 site in Egypt.
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 3 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 25 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 Egypt. 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?
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?
compare numbers of reintervention between groups (time frame: 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 25 Oct 2021.