NCT06867263

Brief Summary

To evaluate the long-term outcome after fulguration of the posterior urethral valve.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started May 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
May 2025Jul 2027

First Submitted

Initial submission to the registry

February 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

February 25, 2025

Last Update Submit

March 7, 2025

Conditions

Posterior Urethral Valve

Outcome Measures

Primary Outcomes (1)

  • The rate of spontaneous voiding with insignificant or absent PMR ( according to equation to age ) after one year from fulguration of the PUV.

    One year postoperative

Interventions

FulgurationPROCEDURE

Posterior urethral valve fulguration

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and children

You may qualify if:

  • Patients with fulguration of PUV since 1 year or more

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24586242BACKGROUND

  • 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.

    PMID: 22925164BACKGROUND

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Central Study Contacts

Keroles Ashraf Soliman Eskaros Dr

CONTACT

+201061875665Keroles.ashraf99@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 10, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 10, 2025

Record last verified: 2025-03