Posterior Urethral ValveNCT06867263
Outcomes of Posterior Urethral Valve Fulguration
An observational study of Posterior Urethral Valve, run by Assiut University.
Trial summary
To evaluate the long-term outcome after fulguration of the posterior urethral valve. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Posterior Urethral Valve
- What is being tested?
- Fulguration
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- Child, Adult, Older adult
Study population: Pediatric and children
Who may be able to join
- Patients with fulguration of PUV since 1 year or more
Who cannot join
- Patients with neurogenic bladder or meningocele or spina bifida .
- Patients with renal parenchymal disease and inflammation not related to posterior urethral valve .
- Diabetic patients .
- Parental refusal .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term Evaluation of Patients With Fulguration of Posterior Urethral Valve: A Retrospective Cohort Study
To evaluate the long-term outcome after fulguration of the posterior urethral valve.
Read the detailed description
Posterior Urethral Valves (PUV) are the most common cause of lower urinary tract obstruction. More severe forms are detected early in pregnancy (mainly type I), while other forms are usually discovered later in childhood when investigating lower urinary tract symptoms. Bladder dysfunction is common and is associated with urinary incontinence in about 55% (0%-72%). Despite the removal of the obstruction by urethral valve ablation, pathological changes in the urinary tract can occur with progressive bladder dysfunction, which can cause deterioration of the upper urinary tract as well. For this reason, all children with PUV require long-term follow-up, always until puberty. In many cases, the life-long current status is uncertain. The current literature lacks research on long-term outcomes.
- Conditions
- Posterior Urethral Valve
- Being tested
- Fulguration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulgurationProcedure or surgery
Posterior urethral valve fulguration
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of spontaneous voiding with insignificant or absent PMR ( according to equation to age ) after one year from fulguration of the PUV.
Measured: One year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posterior Urethral ValveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, keroles Ashraf Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867263
- Sponsor's protocol ID
- Posterior urthral valve
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hennus PM, de Kort LM, Bosch JL, de Jong TP, van der Heijden GJ. A systematic review on the accuracy of diagnostic procedures for infravesical obstruction in boys. PLoS One. 2014 Feb 20;9(2):e85474. doi: 10.1371/journal.pone.0085474. eCollection 2014.
PubMed 24586242Malin G, Tonks AM, Morris RK, Gardosi J, Kilby MD. Congenital lower urinary tract obstruction: a population-based epidemiological study. BJOG. 2012 Nov;119(12):1455-64. doi: 10.1111/j.1471-0528.2012.03476.x. Epub 2012 Aug 24.
PubMed 22925164
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Patients With Fulguration of Posterior Urethral Valve: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06867263
- Acronym / sponsor ID
- Posterior urthral valve
- Conditions
- Posterior Urethral Valve
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Mar 2025 (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 evaluate the long-term outcome after fulguration of the posterior urethral valve.
Detailed description
Posterior Urethral Valves (PUV) are the most common cause of lower urinary tract obstruction. More severe forms are detected early in pregnancy (mainly type I), while other forms are usually discovered later in childhood when investigating lower urinary tract symptoms. Bladder dysfunction is common and is associated with urinary incontinence in about 55% (0%-72%). Despite the removal of the obstruction by urethral valve ablation, pathological changes in the urinary tract can occur with progressive bladder dysfunction, which can cause deterioration of the upper urinary tract as well. For this reason, all children with PUV require long-term follow-up, always until puberty. In many cases, the life-long current status is uncertain. The current literature lacks research on long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and children
Key inclusion criteria (1 listed)
- Patients with fulguration of PUV since 1 year or more
Key exclusion criteria (4 listed)
- Patients with neurogenic bladder or meningocele or spina bifida .
- Patients with renal parenchymal disease and inflammation not related to posterior urethral valve .
- Diabetic patients .
- Parental refusal .
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 |
|---|---|---|
| FulgurationPosterior urethral valve fulguration | Procedure or surgery | – |
Primary outcome
The rate of spontaneous voiding with insignificant or absent PMR ( according to equation to age ) after one year from fulguration of the PUV.
Time frame: One year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Results publication: PubMed 24586242Hennus PM, de Kort LM, Bosch JL, de Jong TP, van der Heijden GJ. A systematic review on the accuracy of diagnostic procedures for infravesical obstruction in boys. PLoS One. 2014 Feb 20;9(2):e85474. doi: 10.1371/journal.pone.0085474. eCollection 2014.
- Results publication: PubMed 22925164Malin G, Tonks AM, Morris RK, Gardosi J, Kilby MD. Congenital lower urinary tract obstruction: a population-based epidemiological study. BJOG. 2012 Nov;119(12):1455-64. doi: 10.1111/j.1471-0528.2012.03476.x. Epub 2012 Aug 24.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Urethral Valve, 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: opening soon, as of the sponsor's last update on 10 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keroles Ashraf Soliman Eskaros Dr (+201061875665, Keroles.ashraf99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of spontaneous voiding with insignificant or absent PMR ( according to equation to age ) after one year from fulguration of the PUV. (time frame: One year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867263, which also lists 2 linked publications.
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 10 Mar 2025.