Pelvic Floor DisordersNCT06728540
Respiratory and Pelvic Floor Muscle Functions of Children With Lower Urinary Tract Dysfunction
A study testing Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function in people with Pelvic Floor Disorders and Lower Urinary Tract Symptoms, run by Seda Yakit Yesilyurt at 1 site in Turkey (Türkiye).
Trial summary
Lower urinary tract dysfunctions (LUTD) are disorders that can occur in the storage and voiding stages of bladder function other than neurological disease or lower urinary tract obstruction. Read more about this study
- Who is it for?
- Ages 6 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Lower Urinary Tract Symptoms, Physical Activity
- What is being tested?
- Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 20 Aug 2025
- Phase
- Interventional
- 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 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed with LUTD,
- Nighttime enuresis at least twice a week for at least 3 consecutive months.
- Daytime enuresis at least once a month for at least 3 consecutive months.
- Girls aged 6-14,
- who consent to participate in the study with the consent of their mother and father or legal guardian (legal representative) will be included in the study.
- Girls aged 6-14,
- who consent to participate in the study with the consent of their mother and father or legal guardian (legal representative) will be included in the study.
Who cannot join
- Children under 6 years of age,
- Anatomical changes in the urinary system,
- Spina bifida,
- History of active urinary tract infection,
- Neurological disease,
- An accompanying respiratory system disease (asthma and a history of frequent upper respiratory tract infections),
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- Cognitive impairment,
- Mental retardation,
- Chronic kidney disease,
- Who have previously undergone orthopedic surgery will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Functions of School-Age Children With Lower Urinary Tract Dysfunction
Lower urinary tract dysfunctions (LUTD) are disorders that can occur in the storage and voiding stages of bladder function other than neurological disease or lower urinary tract obstruction. Storage symptoms are increased or decreased voiding frequency, urinary incontinence, urgency and nocturia, while voiding symptoms are classified as hesitation, straining, weak stream and intermittent voiding. Other symptoms are holding maneuvers, feeling of incomplete voiding, post-voiding dripping, genital and lower urinary tract pain. Epidemiological studies show that the prevalence of LUTD is high in school-aged children, with rates as high as 22%. Very little is known about pelvic floor muscle training in children. Relaxation in the pelvic floor muscles is very important for the continuity of micturition and defecation functions. Respiratory function is one of the key elements in the relaxation of the pelvic floor. The relationship of the pelvic floor muscles with the diaphragm and their role in intra-abdominal pressure regulation have been demonstrated by many studies. In the adult population, it has been emphasized that the respiratory pattern should be corrected in pelvic floor dysfunctions and pelvic floor muscle training should be provided in those with respiratory problems. In the literature, rehabilitation programs for children with LUTD are treatment approaches in which respiratory and pelvic floor muscle training are applied together, but it has not been clearly stated which isolated approach is responsible for the resulting effect. In addition, these studies have emphasized that diaphragmatic exercises reduce or improve symptoms through the relaxation mechanism they create in the abdominal wall. However, unlike the literature, one of the aims of this study is to reveal the relationship between inspiratory and expiratory muscle strength and LUTD.
- Being tested
- Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function
- Keywords
- Pelvic Floor Disorders,, Lower Urinary Tract Dysfunction, Physical Activity
- Medical subject headings
- Pelvic Floor Disorders, Lower Urinary Tract Symptoms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle FunctionOther
The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with an evaluation form, respiratory muscle strength with an RP Check brand electronic pressure measurement device, and body composition with a Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with a 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents.
| Study group | Role | What they receive |
|---|---|---|
| Children with Lower Urinary Tract Dysfunction (Study Group) | Experimental | Children included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents. Receives: Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function |
| Healthy Children (Control Group) | Other | Children included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents. Receives: Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of Respiratory Muscle
To measure respiratory muscle strength, maximal inspiratory pressure (MIP or PImax) and maximal expiratory pressure (MEP or PEmax) measurements will be used with a non-invasive, RP Check brand electronic pressure measuring device.
Measured: baseline
Level of Physical Activity
Physical Activity Questionnaire for Children (PAQ-C):The physical activity levels of children will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). The PAQ-C was developed in Canada to evaluate moderate to vigorous physical activity levels. It is based on the child's self-reported recall of the previous 7 days. The PAQ-C consists of 10 items, with 9 items used to calculate the activity score.
The first question includes a list of 22 commonly performed activities. Responses to this question are evaluated on a 5-point scale (1 = never, 5 = 7 times or more). An average score is calculated, with higher scores indicating higher levels of physical activity.
Measured: baseline
Secondary outcomes (3)
Voiding Disorders
Voiding Disorders Symptom Score (VOS):The severity of voiding dysfunction symptoms in children will be assessed using the Voiding Dysfunction Symptom Score. This score was developed by Akbal et al. in 2005 and consists of 14 questions in total. Thirteen of the questions evaluate symptoms related to daytime urinary incontinence, nighttime urinary incontinence, daily voiding frequency, the presence of constipation, and various symptoms associated with urinary incontinence. The 14th question assesses the impact of these symptoms on quality of life. The total score of the scale ranges from 0 to 35 points, with higher scores indicating increased severity of voiding dysfunction symptoms.
Measured: baseline
Bladder and Bowel Dysfunction
Bladder and Bowel Dysfunction Scale (BDS):The severity of children's bladder and bowel dysfunction symptoms will be assessed with the Bladder and Bowel Dysfunction Scale. The MBDS was developed by Afshar et al. in 2009. Bladder and bowel dysfunction symptoms are assessed and diagnosed with this scale. Its Turkish validity and reliability were made by Kaya Narter et al. in 2017. The scale consists of 14 questions. The first 13 questions are specific to bladder and bowel dysfunction symptoms. The last question questions the degree of difficulty of completing the survey. Each question is a 5-point Likert type and the last question is not added to the scoring. The total score varies between 0-52 and an increase in the score means an increase in symptom severity.
Measured: baseline
Functions of Pelvic Floor Muscle
After a brief informative training using visuals about pelvic floor muscles and their functions, the electrical activity of the pelvic floor muscles of children with LUTD will be measured with the 632 Myomed biofeedback device.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seda Yakit Yesilyurt
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Seda Yakit Yesilyurt, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728540
- Sponsor's protocol ID
- SYY_İEU_3
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Functions of School-Age Children With Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT06728540
- Acronym / sponsor ID
- SYY_İEU_3
- Keywords
- Pelvic Floor Disorders,, Lower Urinary Tract Dysfunction, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Seda Yakit YesilyurtUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 11 Dec 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.
Lower urinary tract dysfunctions (LUTD) are disorders that can occur in the storage and voiding stages of bladder function other than neurological disease or lower urinary tract obstruction. Storage symptoms are increased or decreased voiding frequency, urinary incontinence, urgency and nocturia, while voiding symptoms are classified as hesitation, straining, weak stream and intermittent voiding. Other symptoms are holding maneuvers, feeling of incomplete voiding, post-voiding dripping, genital and lower urinary tract pain. Epidemiological studies show that the prevalence of LUTD is high in school-aged children, with rates as high as 22%. Very little is known about pelvic floor muscle training in children. Relaxation in the pelvic floor muscles is very important for the continuity of micturition and defecation functions. Respiratory function is one of the key elements in the relaxation of the pelvic floor. The relationship of the pelvic floor muscles with the diaphragm and their role in intra-abdominal pressure regulation have been demonstrated by many studies. In the adult population, it has been emphasized that the respiratory pattern should be corrected in pelvic floor dysfunctions and pelvic floor muscle training should be provided in those with respiratory problems. In the literature, rehabilitation programs for children with LUTD are treatment approaches in which respiratory and pelvic floor muscle training are applied together, but it has not been clearly stated which isolated approach is responsible for the resulting effect. In addition, these studies have emphasized that diaphragmatic exercises reduce or improve symptoms through the relaxation mechanism they create in the abdominal wall. However, unlike the literature, one of the aims of this study is to reveal the relationship between inspiratory and expiratory muscle strength and LUTD.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Lower Urinary Tract Dysfunction (Study Group) | Experimental | Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle FunctionChildren included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents. |
| Healthy Children (Control Group) | Other | Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle FunctionChildren included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosed with LUTD,
- Nighttime enuresis at least twice a week for at least 3 consecutive months.
- Daytime enuresis at least once a month for at least 3 consecutive months.
- Girls aged 6-14,
- who consent to participate in the study with the consent of their mother and father or legal guardian (legal representative) will be included in the study.
Key exclusion criteria (10 listed)
- Children under 6 years of age,
- Anatomical changes in the urinary system,
- Spina bifida,
- History of active urinary tract infection,
- Neurological disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle FunctionThe sociodemographic and clinical characteristics of the children participating in the study will be evaluated with an evaluation form, respiratory muscle strength with an RP Check brand electronic pressure measurement device, and body composition with a Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with a 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents. | Other | Children with Lower Urinary Tract Dysfunction (Study Group), Healthy Children (Control Group) |
Primary outcome
Strength of Respiratory Muscle
Time frame: baseline
To measure respiratory muscle strength, maximal inspiratory pressure (MIP or PImax) and maximal expiratory pressure (MEP or PEmax) measurements will be used with a non-invasive, RP Check brand electronic pressure measuring device.
Level of Physical Activity
Time frame: baseline
Physical Activity Questionnaire for Children (PAQ-C):The physical activity levels of children will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). The PAQ-C was developed in Canada to evaluate moderate to vigorous physical activity levels. It is based on the child's self-reported recall of the previous 7 days. The PAQ-C consists of 10 items, with 9 items used to calculate the activity score. The first question includes a list of 22 commonly performed activities. Responses to this question are evaluated on a 5-point scale (1 = never, 5 = 7 times or more). An average score is calculated, with higher scores indicating higher levels of physical activity.
3 secondary outcomes
Voiding Disorders
Time frame: baseline
Bladder and Bowel Dysfunction
Time frame: baseline
Functions of Pelvic Floor Muscle
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function in people with Pelvic Floor Disorders and Lower Urinary Tract Symptoms, run by Seda Yakit Yesilyurt 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 29 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strength of Respiratory Muscle (time frame: baseline). The study lists 2 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 29 Aug 2025.