Lower Urinary Tract SymptomsNCT06317116
Examining the Relationship Between Core Muscles and Bladder Issues in Children
An observational study of Lower Urinary Tract Symptoms and Skeletal Muscle, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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? Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Skeletal Muscle
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Child, Adult
Study population: Patients referred to the Pediatric Urology Clinic at Ege University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Hospital Pediatric Urology Outpatient Clinic
Izmir
About this study
Official title: Investigation of the Relationship Between Core Muscle Functions and Lower Urinary System Symptoms in Children
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?
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms, Skeletal Muscle
- Keywords
- lower urinary tract symptoms, children, physical therapy, core muscles
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: seven days
Secondary outcomes (2)
Superficial Electromyography (EMG)
A NeuroTrac MyoPlus 4 PRO (Verity Medical LTD., UK) type EMG device will be used in the study. Bioelectrical activities of the muscles (pelvic floor muscles, abdominal muscles, diaphragm, multifidus) will be recorded with disposable 3.2 x 3.2 cm superficial electrodes. To reduce skin impedance, the skin area will be cleaned with an alcohol swab. Active electrodes will be placed on the right side of the body, parallel to the muscle fibers, according to the reference points. The reference electrode will be placed on the anterior superior iliac spine. Measurements will be performed during five seconds of maximal voluntary contraction ('work' phase EMG activity) and five seconds of relaxation ('rest' phase EMG activity) of the pelvic floor muscles. Measurements will be repeated for three times. The graphic and numerical data provided by the device will be recorded in the evaluation form.
Measured: At the time of the initial physiotherapist examination
Ultrasonography (USG)
Pelvic floor displacement, endurance, phasic contraction and coordination, bladder volume, bladder wall thickness and post voiding residue, abdominal muscles and multifidus thicknesses, diaphragmatic displacement and thickness will be measured. A transabdominal diagnostic USG device (Sonospace SSI-600) with a low frequency (2-5 MHz) curvilinear transducer will be used. Muscle thickness and distance measurements will be made during frozen imaging. Muscle thickness will be measured between the upper border of the muscle fascia, which appears as a white line, and the end point of the lower border. Measurements will be taken at the expiration and during a five-second pelvic floor muscle contraction. Both measurement results will be recorded in millimeters. All measurements will be repeated three times and the average values will be noted on the evaluation form.
Measured: At the time of the initial physiotherapist examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start29 Sep 2023
- Primary completion29 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University, Ege University Medical School, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Büşra PALAZ, Izmir Bakircay University
- Investigators
- Özge Çeliker Tosun, Study director, Dokuz Eylul UniversityBüşra Palaz, Principal investigator, Izmir Bakircay Universityİbrahim Ulman, Principal investigator, Ege UniversityAli Tekin, Principal investigator, Ege UniversitySibel Tiryaki Birol, Principal investigator, Ege UniversityNuray Elibol, Principal investigator, Ege UniversityBarış Yücel, Principal investigator, Ege UniversityEzgi Altun Tanıl, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317116
- Sponsor's protocol ID
- 2023/09-14
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Muscle Functions and Lower Urinary System Symptoms in Children
- ClinicalTrials.gov ID
- NCT06317116
- Acronym / sponsor ID
- 2023/09-14
- Conditions
- Lower Urinary Tract Symptoms, Skeletal Muscle
- Keywords
- lower urinary tract symptoms, children, physical therapy, core muscles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Dokuz Eylul University, Ege University Medical School, The Scientific and Technological Research Council of Turkey
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients referred to the Pediatric Urology Clinic at Ege University Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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.
2 secondary outcomes
Superficial Electromyography (EMG)
Time frame: At the time of the initial physiotherapist examination
Ultrasonography (USG)
Time frame: At the time of the initial physiotherapist examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özge Çeliker Tosun study director
Dokuz Eylul University
Büşra Palaz principal investigator
Izmir Bakircay University
İbrahim Ulman principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Skeletal Muscle, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunctional Voiding and Incontinence Scoring System (DVAISS) (time frame: At the time of the initial physiotherapist examination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.