The Effect of the Diaphragm in Urinary Incontinence

September 27, 2022 updated by: Sümeyra Kapucu, Kırıkkale University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Kırıkkale, Turkey, 71000
        • Recruiting
        • KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be conducted with children diagnosed with urinary incontinence in Kırıkale University Medical Faculty Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: POWER breathe K5
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
Other: POWER breathe K5
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
Other: POWER breathe K5
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
Other: POWER breathe K5
Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of six months
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.
through study completion, an average of six months
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.
through study completion, an average of six months
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.
through study completion, an average of six months
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.
through study completion, an average of six months
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.
through study completion, an average of six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Investigators

  • Study Director: Sümeyra KAPUCU, PT, Graduate student at Kırıkkale University
  • Study Chair: Meral SERTEL, Assoc. Prof., Associate professor at Kırıkkale University
  • Principal Investigator: Yaşar KANDUR, Assoc. Prof., Kırıkkale University, Faculty of Medicine, Pediatric Nephrology Specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 25, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KırıkkaleUniversity71

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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