NCT05126732

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 28, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

October 28, 2021

Last Update Submit

November 16, 2021

Conditions

Keywords

enuresisoptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Difference in ganglion cell thickness in enuretic children

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

    Baseline

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients aged 5-18 years, with enuresis, without any eye disease

You may qualify if:

  • be between the ages of 5-18
  • have enuresis

You may not qualify if:

  • have any eye conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakircay University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Nocturnal EnuresisGanglion CystsChronobiology DisordersEnuresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersCystsNeoplasmsMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 19, 2021

Study Start

January 1, 2022

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations