NCT03742570

Brief Summary

Objectives:The aim of this study was to translate the Childhood Bladder and Bowel Dysfunction Questionnaire into Turkish, adapt it for use with parents of 5-12 year old children and determine the reliability and construct validity of the Turkish version. The main hypothesis of our study was that it would be possible to translate and culturally adapt the CBBDQ into a Turkish version, so that Turkish parents could understand it. Additionally, we hypothesized that the Turkish version would provide adequate internal consistency and test-rest reliability and acceptable construct validity. Methods:The Childhood Bladder and Bowel Dysfunction Questionnaire was guideline driven translated into Turkish and administered twice, at 7-day intervals, to parents of children to assess test-retest reliability. Cronbach's α was used for internal consistency and the inter-rater correlation coefficient was used to calculate test-retest reliability. The Dysfunctional Voiding and Incontinence Scoring System (DVISS) and Pediatric Quality of Life Inventory (PedsQL) in 5-7, 8-12 years old children were used as an external criterion to estimate construct validity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

2.2 years

First QC Date

November 4, 2018

Last Update Submit

November 15, 2018

Conditions

Keywords

Childhood Bladder and Bowel Dysfunction QuestionnaireReliabilityTurkish

Outcome Measures

Primary Outcomes (1)

  • DVISS

    The DVISS is a 14-item questionnaire originally designed in Turkish with the aim to diagnose patients with dysfunctional voiding. The DVISS includes 12 questions on bladder dysfunction, one on bowel dysfunctions and one on quality of life and has variable (Likert scales, dichotomous) answering options. The total score ranged from 0 to 35 points; sum scores higher from 9 points indicate increased disease severity

    2017-2018

Study Arms (1)

CBBDQ

A Questionnaire

Behavioral: CBBDQ

Interventions

CBBDQBEHAVIORAL

a questionnaire for childood bladder and bowel dysfunctions

CBBDQ

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study was conducted as a questionnaire-based cross-sectional survey of parents of children (5-12y) with urinary incontinence, enuresis, constipation/fecal incontinence.

You may qualify if:

  • parents of children, aged between 5 to 12 years;
  • whose children suffered from urinary incontinence, enuresis nocturia, constipation/fecal incontinence;
  • parents and children read and approved the informed consent form.

You may not qualify if:

  • the presence of urinary tract infection;
  • patients having spinal cord injury or neurological disease;
  • not being able to communicate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gamze Aydin, MSc

    Okan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 15, 2018

Study Start

April 13, 2016

Primary Completion

June 15, 2018

Study Completion

October 15, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share