The Effect of the Diaphragm in Urinary Incontinence

NCT ID: NCT05069207

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-05

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

POWER breathe K5

Intervention Type OTHER

Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

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

POWER breathe K5

Intervention Type OTHER

Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

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

POWER breathe K5

Intervention Type OTHER

Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

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

POWER breathe K5

Intervention Type OTHER

Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POWER breathe K5

Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being diagnosed with urinary incontinence

* Being between the ages of 5 -18
* Accepting participation in the research,

Exclusion Criteria

* • Less than 5 years old,

* With spina bifida,
* Having frequent urinary tract infections,
* Having a neurological disease,
* Having a concomitant chronic disease,
* Cognitive affect,
* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sümeyra Kapucu

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sümeyra KAPUCU, PT

Role: STUDY_DIRECTOR

Graduate student at Kırıkkale University

Meral SERTEL, Assoc. Prof.

Role: STUDY_CHAIR

Associate professor at Kırıkkale University

Yaşar KANDUR, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University, Faculty of Medicine, Pediatric Nephrology Specialist

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kirikkale University Faculty of Medicine

Kırıkkale, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sümeyra Kapucu, PT

Role: CONTACT

+905465457109

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yaşar KANDUR, Assoc. prof

Role: primary

+905433060019

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KırıkkaleUniversity71

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.