- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867263
Outcomes of Posterior Urethral Valve Fulguration
March 7, 2025 updated by: keroles Ashraf Soliman, Assiut University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Keroles Ashraf Soliman Eskaros Dr
- Phone Number: +201061875665
- Email: Keroles.ashraf99@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pediatric and children
Description
Inclusion Criteria:
- Patients with fulguration of PUV since 1 year or more
Exclusion Criteria:
- 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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
One year postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Malin 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
February 25, 2025
First Submitted That Met QC Criteria
March 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 7, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Posterior urthral valve
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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