The Effect of the Diaphragm in Urinary Incontinence

NCT05069207 | Unknown

• 1 other identifier: KırıkkaleUniversity71
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Incontinence

Keywords

diaphragmatic breathing

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  through study completion, an average of six months

Study Arms (4)

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

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

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

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

Interventions

POWER breathe K5 OTHER

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

Control Group Healthy Individuals; Daytime Urinary Incontinence; Monosymptomatic Enuresis; Non-monosymptomatic Enuresis

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Being diagnosed with urinary incontinence
• Being between the ages of 5 -18
• Accepting participation in the research,

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kirikkale University Faculty of Medicine

Kırıkkale, 71000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sümeyra KAPUCU, PT

  Graduate student at Kırıkkale University

  STUDY DIRECTOR

• Meral SERTEL, Assoc. Prof.

  Associate professor at Kırıkkale University

  STUDY CHAIR

• Yaşar KANDUR, Assoc. Prof.

  Kırıkkale University, Faculty of Medicine, Pediatric Nephrology Specialist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyra Kapucu, PT

CONTACT

+905465457109; sumeyra.kapucu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 6, 2021
• Study Start: February 5, 2021
• Primary Completion: December 30, 2022
• Study Completion: February 28, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-03

Locations

TU (1)