Urinary IncontinenceNCT05069207
The Effect of the Diaphragm in Urinary Incontinence
An observational study of Urinary Incontinence, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Urinary incontinence in children is defined as involuntary leakage of urine. Urinary incontinence is the most common urological complaint in children. Many factors are effective in urinary incontinence. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- POWER breathe K5
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 28 Feb 2023
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will be conducted with children diagnosed with urinary incontinence in Kırıkale University Medical Faculty Hospital.
Who may be able to join
- Being diagnosed with urinary incontinence
- Being between the ages of 5 -18
- Accepting participation in the research,
Who cannot join
- • Less than 5 years old,
- With spina bifida,
- Having frequent urinary tract infections,
- Having a neurological disease,
- Having a concomitant chronic disease,
- Cognitive affect,
Show all 10Show fewer
- Having mental retardation,
- Having undergone orthopedic surgery before,
- In addition to nocturnal incontinence, overactive bladder, delayed voiding, underactive bladder, dysfunctional voiding, bladder outlet obstruction, stress urinary incontinence, vaginal reflux, giggle incontinence, bladder neck dysfunction, neurogenic bladder, urgency
- Those who do not agree to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirikkale University Faculty of Medicine
Kirikkale, 71000
Yaşar KANDUR, Assoc. prof, +905433060019, yaskan30@yahoo.com
About this study
Official title: EVALUATION OF DIAPRAGMATIC BREATHING IN POSTURAL STABILIZATION IN CHILDREN WITH URINARY INCONTINENCE
Urinary incontinence in children is defined as involuntary leakage of urine. Urinary incontinence is the most common urological complaint in children. Many factors are effective in urinary incontinence. Research on the effectiveness of the diaphragm in postural stabilization, which the investigators think is one of these factors, is limited. The aim of this study is to compare the effectiveness of diaphragmatic breathing in postural stabilization with healthy individuals and individuals with urinary incontinence. As a result, it has been revealed that one factor of urinary incontinence is due to the dysfunction of diaphragmatic breathing and will be a step to increase awareness on diaphragmatic breathing.
Read the detailed description
Urinary incontinence in children is defined as involuntary leakage of urine. Urinary incontinence is the most common urological complaint in children. Nocturnal incontinence is the most common chronic problem of childhood as well as allergic diseases. Frequency rates of 5-15% are reported in various sources, and in studies conducted with school children in our country, quite high rates of 20-30% are found. It is estimated that there are over 50 million children with urinary incontinence worldwide.
There are many studies in the literature to determine the epidemiology and causes of urinary incontinence. In this study, it is aimed to evaluate diaphragmatic breathing in postural stabilization in children with urinary incontinence. In our study, Kırıkkale University Faculty of Medicine hospital; Individuals between the ages of 5 and 18 who were diagnosed with urinary incontinence and volunteered to participate in the study will be included in the study. The number of individuals will be determined according to the power analysis to be made. Individuals will be divided into 4 groups according to their diagnosis. Four groups with monosymptomatic enuresis, non-monosymptomatic enuresis, daytime urinary incontinence and healthy children as the control group will be included in the study. Before individuals; Demographic characteristics such as age, gender, height and weight will be questioned.
Quality of Life in Children with Urinary Incontinence Scale (PIN-Q), which is the evaluation parameters of the children included in the study, Voiding Disorders Symptom Score (IBSS) to assess the severity of children's voiding disorder symptoms , Dynamic Neuromuscular stabilization (DNS) to evaluate the diaphragm in postural stabilization ; S-index (Inspiratory muscle strength), Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate.
Hypotheses :
H01: Diaphragmatic breathing is active in postural stabilization in children with monosymptomatic enuresis compared to healthy children.
H02: Diaphragmatic respiration is active in postural stabilization in children with non-monosymptomatic enuresis compared to healthy children.
H03: Diaphragmatic breathing is active in postural stabilization in children with daytime urinary incontinence compared to healthy children.
H1: In children with monosymptomatic enuresis, diaphragmatic breathing is not active in postural stabilization compared to healthy children.
H2: Non-monosymptomatic In postural stabilization in children with enuresis, diaphragmatic breathing is not active compared to healthy children.
H3: Diaphragmatic breathing is not active in postural stabilization in children with daytime Urinary Incontinence compared to healthy children.
One of our aims in this study is to realize the importance of the diaphragm.
- Conditions
- Urinary Incontinence
- Being tested
- POWER breathe K5
- Keywords
- diaphragmatic breathing
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER breathe K5Other
Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate
| Study group | Role | What they receive |
|---|---|---|
| Monosymptomatic Enuresis | Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate Receives: Other: POWER breathe K5 | |
| Non-monosymptomatic Enuresis | Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate Receives: Other: POWER breathe K5 | |
| Daytime Urinary Incontinence | Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate Receives: Other: POWER breathe K5 | |
| Control Group Healthy Individuals | Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate Receives: Other: POWER breathe K5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale in Children with Urinary Incontinence (PIN-Q)
It consists of 20 questions. Children are asked to rate each question between 0 and 4 (0=no, 1=never, 2=sometimes, 3=often, 4=always). The total score of the scale ranges from 0 to 80 points. An increase in the total score means that the quality of life of the child is negatively affected.
Measured: through study completion, an average of six months
Voiding Disorders Symptom Score (IBSS)
It measures the severity of children's voiding disorder symptoms. It consists of 14 questions in total. The 13 questions of the questionnaire evaluate symptoms related to daytime incontinence, symptoms related to nocturnal incontinence, frequency of urination in one day, presence of constipation and various urinary incontinence related symptoms. The 14th question evaluates the impact on quality of life in relation to these symptoms.The total score of the scale ranges from 0 to 35 points. An increase in the total score means that the severity of voiding disorders symptom severity increases.
Measured: through study completion, an average of six months
Dynamic Neuromuscular stabilization (DNS)
In the DNS approach, the dual function of the diaphragm, namely respiratory and postural function, is evaluated.
Measured: through study completion, an average of six months
POWERbreathe K5
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. S-index (Inspiratory muscle strength), will be evaluated.
Measured: through study completion, an average of six months
POWERbreathe K5
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. Maximum inspiratory pressure (MIP) will be evaluated.
Measured: through study completion, an average of six months
POWERbreathe K5
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. Volume (Volume (V)) will be evaluated.
Measured: through study completion, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start5 Feb 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyra Kapucu, Kırıkkale University
- Investigators
- Sümeyra KAPUCU, PT, Study director, Graduate student at Kırıkkale UniversityMeral SERTEL, Assoc. Prof., Study chair, Associate professor at Kırıkkale UniversityYaşar KANDUR, Assoc. Prof., Principal investigator, Kırıkkale University, Faculty of Medicine, Pediatric Nephrology Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069207
- Sponsor's protocol ID
- KırıkkaleUniversity71
- Status last verified
- Mar 2022
- First submitted
- 16 Sep 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF DIAPRAGMATIC BREATHING IN POSTURAL STABILIZATION IN CHILDREN WITH URINARY INCONTINENCE
- ClinicalTrials.gov ID
- NCT05069207
- Acronym / sponsor ID
- KırıkkaleUniversity71
- Conditions
- Urinary Incontinence
- Keywords
- diaphragmatic breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 6 Oct 2021 (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.
Urinary incontinence in children is defined as involuntary leakage of urine. Urinary incontinence is the most common urological complaint in children. Many factors are effective in urinary incontinence. Research on the effectiveness of the diaphragm in postural stabilization, which the investigators think is one of these factors, is limited. The aim of this study is to compare the effectiveness of diaphragmatic breathing in postural stabilization with healthy individuals and individuals with urinary incontinence. As a result, it has been revealed that one factor of urinary incontinence is due to the dysfunction of diaphragmatic breathing and will be a step to increase awareness on diaphragmatic breathing.
Detailed description
Urinary incontinence in children is defined as involuntary leakage of urine. Urinary incontinence is the most common urological complaint in children. Nocturnal incontinence is the most common chronic problem of childhood as well as allergic diseases. Frequency rates of 5-15% are reported in various sources, and in studies conducted with school children in our country, quite high rates of 20-30% are found. It is estimated that there are over 50 million children with urinary incontinence worldwide.
There are many studies in the literature to determine the epidemiology and causes of urinary incontinence. In this study, it is aimed to evaluate diaphragmatic breathing in postural stabilization in children with urinary incontinence. In our study, Kırıkkale University Faculty of Medicine hospital; Individuals between the ages of 5 and 18 who were diagnosed with urinary incontinence and volunteered to participate in the study will be included in the study. The number of individuals will be determined according to the power analysis to be made. Individuals will be divided into 4 groups according to their diagnosis. Four groups with monosymptomatic enuresis, non-monosymptomatic enuresis, daytime urinary incontinence and healthy children as the control group will be included in the study. Before individuals; Demographic characteristics such as age, gender, height and weight will be questioned.
Quality of Life in Children with Urinary Incontinence Scale (PIN-Q), which is the evaluation parameters of the children included in the study, Voiding Disorders Symptom Score (IBSS) to assess the severity of children's voiding disorder symptoms , Dynamic Neuromuscular stabilization (DNS) to evaluate the diaphragm in postural stabilization ; S-index (Inspiratory muscle strength), Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate.
Hypotheses :
H01: Diaphragmatic breathing is active in postural stabilization in children with monosymptomatic enuresis compared to healthy children.
H02: Diaphragmatic respiration is active in postural stabilization in children with non-monosymptomatic enuresis compared to healthy children.
H03: Diaphragmatic breathing is active in postural stabilization in children with daytime urinary incontinence compared to healthy children.
H1: In children with monosymptomatic enuresis, diaphragmatic breathing is not active in postural stabilization compared to healthy children.
H2: Non-monosymptomatic In postural stabilization in children with enuresis, diaphragmatic breathing is not active compared to healthy children.
H3: Diaphragmatic breathing is not active in postural stabilization in children with daytime Urinary Incontinence compared to healthy children.
One of our aims in this study is to realize the importance of the diaphragm.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monosymptomatic Enuresis | – | Other: POWER breathe K5Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate |
| Non-monosymptomatic Enuresis | – | Other: POWER breathe K5Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate |
| Daytime Urinary Incontinence | – | Other: POWER breathe K5Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate |
| Control Group Healthy Individuals | – | Other: POWER breathe K5Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) Voiding Disorders Symptom Score (IBSS) Dynamic Neuromuscular Stabilization (DNS) Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted with children diagnosed with urinary incontinence in Kırıkale University Medical Faculty Hospital.
Key inclusion criteria (3 listed)
- Being diagnosed with urinary incontinence
Key exclusion criteria (10 listed)
- • Less than 5 years old,
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 |
|---|---|---|
| POWER breathe K5Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate | Other | Control Group Healthy Individuals, Daytime Urinary Incontinence, Monosymptomatic Enuresis, Non-monosymptomatic Enuresis |
Primary outcome
Quality of Life Scale in Children with Urinary Incontinence (PIN-Q)
Time frame: through study completion, an average of six months
It consists of 20 questions. Children are asked to rate each question between 0 and 4 (0=no, 1=never, 2=sometimes, 3=often, 4=always). The total score of the scale ranges from 0 to 80 points. An increase in the total score means that the quality of life of the child is negatively affected.
Voiding Disorders Symptom Score (IBSS)
Time frame: through study completion, an average of six months
It measures the severity of children's voiding disorder symptoms. It consists of 14 questions in total. The 13 questions of the questionnaire evaluate symptoms related to daytime incontinence, symptoms related to nocturnal incontinence, frequency of urination in one day, presence of constipation and various urinary incontinence related symptoms. The 14th question evaluates the impact on quality of life in relation to these symptoms.The total score of the scale ranges from 0 to 35 points. An increase in the total score means that the severity of voiding disorders symptom severity increases.
Dynamic Neuromuscular stabilization (DNS)
Time frame: through study completion, an average of six months
In the DNS approach, the dual function of the diaphragm, namely respiratory and postural function, is evaluated.
POWERbreathe K5
Time frame: through study completion, an average of six months
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. S-index (Inspiratory muscle strength), will be evaluated.
POWERbreathe K5
Time frame: through study completion, an average of six months
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. Maximum inspiratory pressure (MIP) will be evaluated.
POWERbreathe K5
Time frame: through study completion, an average of six months
It is a respiratory muscle force measurement device. It is designed to match dynamic changes in respiratory muscle strength throughout the breath. Volume (Volume (V)) will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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.
Sümeyra KAPUCU, PT study director
Graduate student at Kırıkkale University
Meral SERTEL, Assoc. Prof. study chair
Associate professor at Kırıkkale University
Yaşar KANDUR, Assoc. Prof. principal investigator
Kırıkkale University, Faculty of Medicine, Pediatric Nephrology Specialist
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 Urinary Incontinence, run by Kırıkkale 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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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?
Contact Sümeyra Kapucu, PT (+905465457109, sumeyra.kapucu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale in Children with Urinary Incontinence (PIN-Q) (time frame: through study completion, an average of six months). The study lists 6 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 28 Sep 2022.