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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05126732
Other study ID # 341/321
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2022
Est. completion date July 2022

Study information

Verified date November 2021
Source Izmir Bakircay University
Contact Yasar ISSI
Phone 00905321704131
Email yasarissi@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - be between the ages of 5-18 - have enuresis Exclusion Criteria: - have any eye conditions

Study Design


Locations

Country Name City State
Turkey Bakircay University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Izmir Bakircay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in ganglion cell thickness in enuretic children Normal values in RNFL measurements on OCT 75 (lowest)-107.2 (highest) Baseline
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