The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

Sponsor
Ankara Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03543995
Collaborator
(none)
330
16.4

Study Details

Study Description

Brief Summary

It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients.

The present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    330 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    May 15, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Enuresis nocturna

    Patients aged 6 to 15 years with at least one night-time wetting weekly

    Normal population

    Patients who were admitted to the urology clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination

    Outcome Measures

    Primary Outcome Measures

    1. Dry bed days [3 months]

      Patients were called for check-up one and three months later. When waking in the morning they were given a form to mark as dry or wet, and dry bed days were examined at check-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 6 to 15 years

    • at least one night-time wetting weekly

    Exclusion Criteria:
    • neurological disease,

    • diabetes mellitus or insipidus,

    • spinal surgery history, spina bifida skin findings,

    • chronic renal insufficiency

    • and secondary enuresis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ankara Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muhammet Fatih Kilinc, Principal Investigator, Ankara Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03543995
    Other Study ID Numbers:
    • 5520
    First Posted:
    Jun 1, 2018
    Last Update Posted:
    Jun 1, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Muhammet Fatih Kilinc, Principal Investigator, Ankara Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2018