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Clinical Trials/NCT06317116
NCT06317116
Enrolling by Invitation
N/A

Investigation of the Relationship Between Core Muscle Functions and Lower Urinary System Symptoms in Children

Izmir Bakircay University1 site in 1 country60 target enrollmentSeptember 29, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Izmir Bakircay University
Enrollment
60
Locations
1
Primary Endpoint
Bladder and Bowel Dysfunction Questionnaire (BBDQ)
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

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?

Detailed Description

The study will be a novel investigation that elucidates the current state by comparing core muscle function outcomes with the type and severity of symptoms in children with lower urinary tract symptoms. It will shed light on the necessity of evaluating not only electromyographic activity during urination but also the overall function of core muscles in children with lower urinary tract symptoms. Additionally, identifying core muscle dysfunctions in children with lower urinary tract symptoms will provide a new perspective in treatment. Consequently, the project will not only contribute to the literature but also serve as a pioneering study that draws attention to the necessity of physical therapy consultation and a multidisciplinary approach in clinical assessment and treatment processes for pediatric urologists. The comprehensive and objective project aims to conduct a reference study on the subject, and the project results will lay the foundation for the development of prevention and improvement strategies. Data will be collected using non-invasive transabdominal ultrasound and surface electromyography to evaluate core muscle functions, and symptom questionnaires. The relationship between core muscle functions and lower urinary tract symptoms in children will be examined. Research Questions: Does lower urinary tract symptoms have an impact on core muscle functions in children? How do core muscle functions change according to an increase or decrease in these symptoms? The study is a cross-sectional research.

Registry
clinicaltrials.gov
Start Date
September 29, 2023
End Date
March 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Izmir Bakircay University
Responsible Party
Principal Investigator
Principal Investigator

Büşra PALAZ

Research Assistant

Izmir Bakircay University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Bladder and Bowel Dysfunction Questionnaire (BBDQ)

Time Frame: At the time of the initial physiotherapist examination

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.

Bowel Diary

Time Frame: seven days

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.

Dysfunctional Voiding and Incontinence Scoring System (DVAISS)

Time Frame: At the time of the initial physiotherapist examination

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.

Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ)

Time Frame: At the time of the initial physiotherapist examination

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.

Bladder Diary

Time Frame: two days

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).

Secondary Outcomes

  • Ultrasonography (USG)(At the time of the initial physiotherapist examination)
  • Superficial Electromyography (EMG)(At the time of the initial physiotherapist examination)

Study Sites (1)

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