The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

May 31, 2018 updated by: Muhammet Fatih Kilinc, Ankara Training and Research Hospital

The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 6 to 15 years who were admitted to an urology outpatient clinics with at least one night-time wetting weekly, were included in this prospective study.

The control group consisted of patients who were admitted to the urology outpatient clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination. The patients who were selected as the control group had night wetness questioned and the dysfunctional voiding symptom score (DVSS) form was completed. Those who had night wetting, neurological disease or diabetes mellitus were not included in the control group.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry bed days
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

May 15, 2018

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (ACTUAL)

June 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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