Examining the Relationship Between Core Muscles and Bladder Issues in Children

NCT06317116 | Enrolling By Invitation

• 1 other identifier: 2023/09-14
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about functional bladder problems in children. The main questions it aims to answer are:

• Does bladder symptoms in children have an effect on core muscles?
• How do core muscles change based on an increase or decrease in these symptoms?

Conditions

Lower Urinary Tract Symptoms; Skeletal Muscle

Keywords

lower urinary tract symptoms; children; physical therapy; core muscles

Outcome Measures

Primary Outcomes (5)

• Dysfunctional Voiding and Incontinence Scoring System (DVAISS)

  DVAISS was developed to evaluate the severity of dysfunctional voiding and incontinence symptoms by Akbal et al. DVAISS consists of 14 questions examining daytime and nighttime symptoms, bladder and bowel habits, and quality of life. DVAISS score is based on the estimated odds ratio for each question between participants and controls. If the estimated odds ratio of the question is between 2 and 10, one point is given and if the estimated odds ratio is greater than 50, five points are given. The total score varies between 0 and 35. The increase in the total score indicates that the severity of the symptoms increases. A score of 8.5 or higher on the scale indicates the presence of bladder and bowel dysfunction. The Cronbach Alpha value of the scale was determined as 0.50.

  At the time of the initial physiotherapist examination

• Bladder and Bowel Dysfunction Questionnaire (BBDQ)

  BBDQ was developed to evaluate symptoms of bladder and bowel dysfunction by Afshar et al. The Turkish validity and reliability was conducted by Kaya Narter et al. BBDQ includes 13 questions about bladder and bowel symptoms such as incontinence, voiding, enuresis, dysuria, and constipation. Each question is scored on a 5-point Likert scale ranging from zero to four points. The total score varies between 0 and 52. As the total score increases, symptom severity worsens. A score of 11 points or above is considered bladder and bowel dysfunction. Cronbach Alpha value of the scale was found to be 0.727.

  At the time of the initial physiotherapist examination

• Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ)

  CBBDQ consists of a total of 18 questions that assess bladder and bowel symptoms in children. CBBDQ has two subdimensions: Bladder Symptoms Scale (10 questions) and Bowel Symptoms Scale (8 questions). Considering the presence of children's symptoms in the last month, CBBDQ is filled out by parents on a 5-point Likert scale ranging from zero (no symptoms) to four points (symptoms occur almost every day). The total score from the scale varies between 0 and 72. As the total score increases, symptoms worsen. The Turkish validity and reliability of the scale was conducted by Aydin et al. Cronbach Alpha values were determined as 0.74 and 0.71 for bladder and bowel subdimensions, respectively.

  At the time of the initial physiotherapist examination

• Bladder Diary

  The bladder diary is a simple and non-invasive method that objectively assesses bladder habits. The bladder diary is used to record the type and amount of consumed fluid over 48 hours, the amount and duration of urination, urgency, urinary frequency, and the amount and time of urinary incontinence. The bladder diary is desirable to record for two consecutive days. The amount of consumed fluid and the urination is expressed in milliliters (ml), and the duration of urination is expressed in seconds (sec).

  two days

• Bowel Diary

  The ICCS recommends the use of a seven-day bowel diary in children with lower urinary tract symptoms due to the close relationship between bladder and bowel function. The bowel diary questions the defecation frequency, pain during defecation, urgency, stool type, and the presence of fecal incontinence. The Bristol Stool Scale is used for stool type. The bowel diary consists of seven pictures and stool form descriptors and allows children to express participants' bowel movement intensity.

  seven days

Secondary Outcomes (2)

• Superficial Electromyography (EMG)

  At the time of the initial physiotherapist examination

• Ultrasonography (USG)

  At the time of the initial physiotherapist examination

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Pediatric Urology Clinic at Ege University Hospital.

You may qualify if:

• To have a diagnosis of lower urinary tract symptoms according to the International Children's Continence Society (ICCS) diagnostic criteria,
• To have a normal neurological examination,
• Not to have received pelvic floor rehabilitation in the last 6 months,
• To be between the ages of 6 and 18.

You may not qualify if:

• To have structural (anatomical) problems in the urinary system such as ectopic ureter, urethral valve issues,
• To have congenital and/or spinal cord injury, acquired neurogenic problems such as spinal dysraphism, pelvic trauma,
• To have active febrile illness or urinary tract infection, or any biomechanical problem such as congenital thoracic deformities that may hinder or affect the evaluation,
• To have cognitive or mental impairment in the child and/or parent.

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Dokuz Eylul University: collaborator
• Ege University Medical School: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University Hospital Pediatric Urology Outpatient Clinic

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özge Çeliker Tosun

  Dokuz Eylul University

  STUDY DIRECTOR

• Büşra Palaz

  Izmir Bakircay University

  PRINCIPAL INVESTIGATOR

• İbrahim Ulman

  Ege University

  PRINCIPAL INVESTIGATOR

• Ali Tekin

  Ege University

  PRINCIPAL INVESTIGATOR

• Sibel Tiryaki Birol

  Ege University

  PRINCIPAL INVESTIGATOR

• Nuray Elibol

  Ege University

  PRINCIPAL INVESTIGATOR

• Barış Yücel

  Ege University

  PRINCIPAL INVESTIGATOR

• Ezgi Altun Tanıl

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: September 29, 2023
• Primary Completion: September 29, 2024
• Study Completion: March 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)