Clinical trial NCT06317116: Examining the Relationship Between Core Muscles and Bladder Issues in Children
Official title: Investigation of the Relationship Between Core Muscle Functions and Lower Urinary System Symptoms in Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lower Urinary Tract Symptoms
Skeletal Muscle
Keywords: lower urinary tract symptoms
children
physical therapy
core muscles
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
name: Ege University Medical School
name: The Scientific and Technological Research Council of Turkey
First posted: 2024-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Pediatric Urology Clinic at Ege University Hospital.

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.

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.

Primary outcomes:
measure: Dysfunctional Voiding and Incontinence Scoring System (DVAISS)
timeFrame: At the time of the initial physiotherapist examination
measure: Bladder and Bowel Dysfunction Questionnaire (BBDQ)
timeFrame: At the time of the initial physiotherapist examination
measure: Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ)
timeFrame: At the time of the initial physiotherapist examination
measure: Bladder Diary
timeFrame: two days
measure: Bowel Diary
timeFrame: seven days
Secondary outcomes:
measure: Superficial Electromyography (EMG)
timeFrame: At the time of the initial physiotherapist examination
measure: Ultrasonography (USG)
timeFrame: At the time of the initial physiotherapist examination
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital Pediatric Urology Outpatient Clinic
Study officials:
affiliation: Dokuz Eylul University
name: Özge Çeliker Tosun
role: STUDY_DIRECTOR
affiliation: Izmir Bakircay University
name: Büşra Palaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İbrahim Ulman
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Ali Tekin
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Sibel Tiryaki Birol
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Nuray Elibol
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Barış Yücel
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Ezgi Altun Tanıl
role: PRINCIPAL_INVESTIGATOR
References: