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Ganglion Cell Thickness in Enuresis Nocturna

Sponsor
Izmir Bakircay University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05126732
Collaborator
(none)
50
Enrollment
1
Location
5.9
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Is Ganglion Cell Thickness the Main Problem in Enuresis Nocturna?
    Anticipated Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Difference in ganglion cell thickness in enuretic children [Baseline]

      Normal values in RNFL measurements on OCT 75 (lowest)-107.2 (highest)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • be between the ages of 5-18

    • have enuresis

    Exclusion Criteria:
    • have any eye conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bakircay University Izmir Turkey

    Sponsors and Collaborators

    • Izmir Bakircay University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasar Issi, Asistant Professor, Izmir Bakircay University
    ClinicalTrials.gov Identifier:
    NCT05126732
    Other Study ID Numbers:
    • 341/321
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasar Issi, Asistant Professor, Izmir Bakircay University
    enuresis
    optical coherence tomography
    Additional relevant MeSH terms:
    Ganglion Cysts
    Synovial Cyst
    Chronobiology Disorders
    Enuresis
    Urinary Incontinence
    Nocturnal Enuresis

    Study Results

    No Results Posted as of Nov 19, 2021