xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003894</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar64</org_study_id>
      <nct_id>NCT06003894</nct_id>
    </id_info>
    <brief_title>360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence</brief_title>
    <official_title>Comparison of the Effectiveness of Kegel Exercises and 360-degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to investigate the effect of transferring the healthy&#xD;
        intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the&#xD;
        patient to the pelvic cavity on incontinence problems.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        66 people with a score of 3 or higher on the Incontinence Severity Index will be included in&#xD;
        the study. All participants will complete the King Health Questionnaire and Incontinence&#xD;
        Quality of Life Questionnaires. The control group will consist of 33 people and will apply&#xD;
        only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will&#xD;
        consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a&#xD;
        week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training&#xD;
        will be given to the experimental group. Practices for using this breathing pattern will be&#xD;
        done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires&#xD;
        will be asked to be filled again. The variation between the initial results and the final&#xD;
        results, as well as the differences between the final changes, will also be compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 20, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>360 degree expanded diaphragm breathing</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incontinence severity index (ISI)</measure>
      <time_frame>10 weeks</time_frame>
      <description>It was developed in epidemiological and clinical studies to identify women with urinary incontinence of varying severity. The questionnaire score is obtained by multiplying the value given to the frequency of urinary incontinence by the value given to the amount of urinary incontinence. The result obtained; classified as mild, moderate, severe, very severe.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Understanding King's Health Questionnaire (KHQ)</measure>
      <time_frame>10 weeks</time_frame>
      <description>The King's Health questionnaire is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. It includes 7 sub-headings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). For other areas, scores range from 0 (best) to -100 (worst).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incontinence Quality of Life Questionnaire (I-QOL)</measure>
      <time_frame>10 weeks</time_frame>
      <description>In the Incontinence Quality of Life Scale (I-QOL), which consists of 22 items, all items are evaluated on a five-category Likert-type scale (1= a lot, 2= a lot, 3= moderately, 4= a little, 5= not at all). The scores of the questionnaire and its subscales are obtained by adding the scores of each item and dividing this total by the number of items. For easier explanation of the scores, the calculated total score is converted to a scale value from 0 (lowest quality of life) to 100 (highest quality of life). High scores indicate better quality of life than low scores.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>kegel group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will only practice kegel exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>diaphragm group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>kegel exercises</intervention_name>
      <description>Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.</description>
      <arm_group_label>diaphragm group</arm_group_label>
      <arm_group_label>kegel group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>360 degree expanded diaphragmatic breathing training</intervention_name>
      <description>360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.</description>
      <arm_group_label>diaphragm group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Getting a score of 3 and above in the incontinence severity index.&#xD;
  &#xD;
            -  Be in the age range of 12-65 years.&#xD;
  &#xD;
            -  No neurological problems.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Having a history of surgery or childbirth in the last 3 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif AKAR</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Üsküdar</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Huang YC, Chang KV. Kegel Exercises. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555898/</citation>
      <PMID>32310358</PMID>
    </reference>
    <reference>
      <citation>Cho ST, Kim KH. Pelvic floor muscle exercise and training for coping with urinary incontinence. J Exerc Rehabil. 2021 Dec 27;17(6):379-387. doi: 10.12965/jer.2142666.333. eCollection 2021 Dec.</citation>
      <PMID>35036386</PMID>
    </reference>
    <reference>
      <citation>Singla N, Aggarwal H, Foster J, Alhalabi F, Lemack GE, Zimmern PE. Management of Urinary Incontinence Following Suburethral Sling Removal. J Urol. 2017 Sep;198(3):644-649. doi: 10.1016/j.juro.2017.02.3341. Epub 2017 Mar 4.</citation>
      <PMID>28267602</PMID>
    </reference>
    <reference>
      <citation>Snodgrass W, Barber T. Comparison of bladder outlet procedures without augmentation in children with neurogenic incontinence. J Urol. 2010 Oct;184(4 Suppl):1775-80. doi: 10.1016/j.juro.2010.04.017. Epub 2010 Aug 21.</citation>
      <PMID>20728128</PMID>
    </reference>
    <reference>
      <citation>Abu Raddaha AH, Nasr EH. Kegel Exercise Training Program among Women with Urinary Incontinence. Healthcare (Basel). 2022 Nov 24;10(12):2359. doi: 10.3390/healthcare10122359.</citation>
      <PMID>36553882</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>kegel exercises</keyword>
    <keyword>urinary incontinence</keyword>
    <keyword>diaphragmatic breathing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Incontinence</mesh_term>
      <mesh_term>Enuresis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003894
  org study id: Uskudar64
  nct id: NCT06003894
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the effect of transferring the healthy
        intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the
        patient to the pelvic cavity on incontinence problems.
  66 people with a score of 3 or higher on the Incontinence Severity Index will be included in
        the study. All participants will complete the King Health Questionnaire and Incontinence
        Quality of Life Questionnaires. The control group will consist of 33 people and will apply
        only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will
        consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a
        week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training
        will be given to the experimental group. Practices for using this breathing pattern will be
        done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires
        will be asked to be filled again. The variation between the initial results and the final
        results, as well as the differences between the final changes, will also be compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 360 degree expanded diaphragm breathing
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The incontinence severity index (ISI)
  time frame: 10 weeks
  description: It was developed in epidemiological and clinical studies to identify women with urinary incontinence of varying severity. The questionnaire score is obtained by multiplying the value given to the frequency of urinary incontinence by the value given to the amount of urinary incontinence. The result obtained; classified as mild, moderate, severe, very severe.
  measure: Understanding King's Health Questionnaire (KHQ)
  time frame: 10 weeks
  description: The King's Health questionnaire is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. It includes 7 sub-headings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). For other areas, scores range from 0 (best) to -100 (worst).
  measure: Incontinence Quality of Life Questionnaire (I-QOL)
  time frame: 10 weeks
  description: In the Incontinence Quality of Life Scale (I-QOL), which consists of 22 items, all items are evaluated on a five-category Likert-type scale (1= a lot, 2= a lot, 3= moderately, 4= a little, 5= not at all). The scores of the questionnaire and its subscales are obtained by adding the scores of each item and dividing this total by the number of items. For easier explanation of the scores, the calculated total score is converted to a scale value from 0 (lowest quality of life) to 100 (highest quality of life). High scores indicate better quality of life than low scores.
  arm group label: kegel group
  arm group type: Active Comparator
  description: Participants will only practice kegel exercises.
  arm group label: diaphragm group
  arm group type: Experimental
  description: In addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.
  intervention type: Other
  intervention name: kegel exercises
  description: Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.
  arm group label: diaphragm group
  arm group label: kegel group
  intervention type: Other
  intervention name: 360 degree expanded diaphragmatic breathing training
  description: 360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.
  arm group label: diaphragm group
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Elif AKAR
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  country: Turkey
  citation: Huang YC, Chang KV. Kegel Exercises. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555898/
  PMID: 32310358
  citation: Cho ST, Kim KH. Pelvic floor muscle exercise and training for coping with urinary incontinence. J Exerc Rehabil. 2021 Dec 27;17(6):379-387. doi: 10.12965/jer.2142666.333. eCollection 2021 Dec.
  PMID: 35036386
  citation: Singla N, Aggarwal H, Foster J, Alhalabi F, Lemack GE, Zimmern PE. Management of Urinary Incontinence Following Suburethral Sling Removal. J Urol. 2017 Sep;198(3):644-649. doi: 10.1016/j.juro.2017.02.3341. Epub 2017 Mar 4.
  PMID: 28267602
  citation: Snodgrass W, Barber T. Comparison of bladder outlet procedures without augmentation in children with neurogenic incontinence. J Urol. 2010 Oct;184(4 Suppl):1775-80. doi: 10.1016/j.juro.2010.04.017. Epub 2010 Aug 21.
  PMID: 20728128
  citation: Abu Raddaha AH, Nasr EH. Kegel Exercise Training Program among Women with Urinary Incontinence. Healthcare (Basel). 2022 Nov 24;10(12):2359. doi: 10.3390/healthcare10122359.
  PMID: 36553882
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Urinary Incontinence
  mesh term: Enuresis
  sharing ipd: No