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/NCT06040333</url>
    </required_header>
    <id_info>
      <org_study_id>ssaka8</org_study_id>
      <nct_id>NCT06040333</nct_id>
    </id_info>
    <brief_title>Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding</brief_title>
    <official_title>The Effect of Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding : A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Halic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Halic 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>
        In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary&#xD;
        flow and quality of life in individuals with dysfunctional voiding was investigated. The 34&#xD;
        participants included in the study were randomized into two groups: the experiment in which&#xD;
        DNS exercises were applied and the standard therapy group in which the manual application was&#xD;
        applied. Uroflowmetry, Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment&#xD;
        Short Form were applied to all participants at baseline and at week 6.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary&#xD;
        flow and quality of life in individuals with dysfunctional voiding was investigated. This&#xD;
        experimental study was conducted with patients who applied to UroKlinik in Istanbul between&#xD;
        March 2021 and June 2023 and were diagnosed with dysfunctional voiding. The 34 participants&#xD;
        included in the study were randomized into two groups: the experiment in which DNS exercises&#xD;
        were applied and the standard therapy group in which the manual application was applied.&#xD;
        Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment Short Form and&#xD;
        Uroflowmetry test were applied to all participants before and at week 6.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 2, 2021</start_date>
    <completion_date type="Actual">June 21, 2023</completion_date>
    <primary_completion_date type="Actual">April 7, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Uroflowmetry - Maximum flow rate (Qmax)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *Qmax (mL/s): Qmax is the fastest stream measured in mL/s.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uroflowmetry - Average flow rate (Qave)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *Qave (mL/s): Qave is the average stream measured in mL/s.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uroflowmetry - Corrected maximum flow rate (cQmax)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *cQmax (mL/s/√ mL): cQmax is the precise assessment of fastest stream, especially at high volumes. Is it estimated Qmax/√ VV.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uroflowmetry - Flow time (FT)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *FT (s): FT is the time over which measurable flow actually occurs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uroflowmetry - Voiding volume (VV)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *VV (ml): VV indicates the amount of voiding.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uroflowmetry - Residual urine (RU)</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>Uroflowmetry gives information about urine flow rate and voiding pattern.&#xD;
  *RU (ml): RU is the amount of urine that is left behind in the bladder after you are done urinating.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dysfunctional Voiding and Incontinence Symptom Score</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>It gives information about voiding and incontinence symptoms. The questionnaire contains fourteen questions about symptoms and quality of life. The total score ranges from 0 to 35 and a score above 8.5 indicates abnormalities.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Form 36</measure>
      <time_frame>at the baseline and at week 6.</time_frame>
      <description>It gives information about health related quality of life. The total score of the scale ranges from 0 to 100, and a high score indicates a high quality of life.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">34</enrollment>
    <condition>Dysfunctional Voiding</condition>
    <arm_group>
      <arm_group_label>Dynamic Neuromuscular Stabilisation Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants performed DNS exercises addition to standard therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard therapy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patient education, massage, diaphragmatic breathing, kegel exercise</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>Dynamic Neuromuscular Stabilisation Exercise</description>
      <arm_group_label>Dynamic Neuromuscular Stabilisation Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard therapy</intervention_name>
      <description>Patient education, massage, diaphragmatic breathing, kegel exercise</description>
      <arm_group_label>Dynamic Neuromuscular Stabilisation Exercise</arm_group_label>
      <arm_group_label>Standard therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having been diagnosed with dysfunctional voiding,&#xD;
  &#xD;
            -  Being between the ages of 18-75,&#xD;
  &#xD;
            -  Not having a neurogenic bladder&#xD;
  &#xD;
            -  Not having a urinary tract infection&#xD;
  &#xD;
            -  Not having an obstacle to exercise,&#xD;
  &#xD;
            -  Accepting and signing the Approval Form,&#xD;
  &#xD;
            -  Not having undergone surgery in the last 6 months,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not being cooperative&#xD;
  &#xD;
            -  Not being able to participate in the treatment,&#xD;
  &#xD;
            -  The use of drugs that will affect urination&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seda Saka, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Haliç University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Haliç University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.</citation>
      <PMID>15711352</PMID>
    </results_reference>
    <results_reference>
      <citation>Altunkol A, Abat D, Sener NC, Gulum M, Ciftci H, Savas M, Yeni E. Is urotherapy alone as effective as a combination of urotherapy and biofeedback in children with dysfunctional voiding? Int Braz J Urol. 2018 Sep-Oct;44(5):987-995. doi: 10.1590/S1677-5538.IBJU.2018.0194.</citation>
      <PMID>30130020</PMID>
    </results_reference>
    <results_reference>
      <citation>Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.</citation>
      <PMID>25772695</PMID>
    </results_reference>
    <results_reference>
      <citation>Haylen BT, Ashby D, Sutherst JR, Frazer MI, West CR. Maximum and average urine flow rates in normal male and female populations--the Liverpool nomograms. Br J Urol. 1989 Jul;64(1):30-8. doi: 10.1111/j.1464-410x.1989.tb05518.x.</citation>
      <PMID>2765766</PMID>
    </results_reference>
    <results_reference>
      <citation>Mahdieh L, Zolaktaf V, Karimi MT. Effects of dynamic neuromuscular stabilization (DNS) training on functional movements. Hum Mov Sci. 2020 Apr;70:102568. doi: 10.1016/j.humov.2019.102568. Epub 2020 Jan 13.</citation>
      <PMID>31950895</PMID>
    </results_reference>
    <results_reference>
      <citation>Zivkovic V, Lazovic M, Vlajkovic M, Slavkovic A, Dimitrijevic L, Stankovic I, Vacic N. Diaphragmatic breathing exercises and pelvic floor retraining in children with dysfunctional voiding. Eur J Phys Rehabil Med. 2012 Sep;48(3):413-21. Epub 2012 Jun 5.</citation>
      <PMID>22669134</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Halic University</investigator_affiliation>
      <investigator_full_name>Duygu Şahin Altaç</investigator_full_name>
      <investigator_title>Principal investigator, MSc, PT</investigator_title>
    </responsible_party>
    <keyword>dysfunctional voiding</keyword>
    <keyword>dynamic neuromuscular stabilization exercise</keyword>
    <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/NCT06040333
  org study id: ssaka8
  nct id: NCT06040333
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary
        flow and quality of life in individuals with dysfunctional voiding was investigated. The 34
        participants included in the study were randomized into two groups: the experiment in which
        DNS exercises were applied and the standard therapy group in which the manual application was
        applied. Uroflowmetry, Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment
        Short Form were applied to all participants at baseline and at week 6.
  In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary
        flow and quality of life in individuals with dysfunctional voiding was investigated. This
        experimental study was conducted with patients who applied to UroKlinik in Istanbul between
        March 2021 and June 2023 and were diagnosed with dysfunctional voiding. The 34 participants
        included in the study were randomized into two groups: the experiment in which DNS exercises
        were applied and the standard therapy group in which the manual application was applied.
        Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment Short Form and
        Uroflowmetry test were applied to all participants before and at week 6.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Uroflowmetry - Maximum flow rate (Qmax)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *Qmax (mL/s): Qmax is the fastest stream measured in mL/s.
  measure: Uroflowmetry - Average flow rate (Qave)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *Qave (mL/s): Qave is the average stream measured in mL/s.
  measure: Uroflowmetry - Corrected maximum flow rate (cQmax)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *cQmax (mL/s/√ mL): cQmax is the precise assessment of fastest stream, especially at high volumes. Is it estimated Qmax/√ VV.
  measure: Uroflowmetry - Flow time (FT)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *FT (s): FT is the time over which measurable flow actually occurs.
  measure: Uroflowmetry - Voiding volume (VV)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *VV (ml): VV indicates the amount of voiding.
  measure: Uroflowmetry - Residual urine (RU)
  time frame: at the baseline and at week 6.
  description: Uroflowmetry gives information about urine flow rate and voiding pattern.
  *RU (ml): RU is the amount of urine that is left behind in the bladder after you are done urinating.
  measure: Dysfunctional Voiding and Incontinence Symptom Score
  time frame: at the baseline and at week 6.
  description: It gives information about voiding and incontinence symptoms. The questionnaire contains fourteen questions about symptoms and quality of life. The total score ranges from 0 to 35 and a score above 8.5 indicates abnormalities.
  measure: Short Form 36
  time frame: at the baseline and at week 6.
  description: It gives information about health related quality of life. The total score of the scale ranges from 0 to 100, and a high score indicates a high quality of life.
  arm group label: Dynamic Neuromuscular Stabilisation Exercise
  arm group type: Experimental
  description: The participants performed DNS exercises addition to standard therapy
  arm group label: Standard therapy
  arm group type: Other
  description: Patient education, massage, diaphragmatic breathing, kegel exercise
  intervention type: Other
  intervention name: Exercise
  description: Dynamic Neuromuscular Stabilisation Exercise
  arm group label: Dynamic Neuromuscular Stabilisation Exercise
  intervention type: Other
  intervention name: Standard therapy
  description: Patient education, massage, diaphragmatic breathing, kegel exercise
  arm group label: Dynamic Neuromuscular Stabilisation Exercise
  arm group label: Standard therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Seda Saka, PhD
  role: Study Director
  affiliation: Haliç University
  facility: 
  country: Turkey
  citation: Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
  PMID: 15711352
  citation: Altunkol A, Abat D, Sener NC, Gulum M, Ciftci H, Savas M, Yeni E. Is urotherapy alone as effective as a combination of urotherapy and biofeedback in children with dysfunctional voiding? Int Braz J Urol. 2018 Sep-Oct;44(5):987-995. doi: 10.1590/S1677-5538.IBJU.2018.0194.
  PMID: 30130020
  citation: Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
  PMID: 25772695
  citation: Haylen BT, Ashby D, Sutherst JR, Frazer MI, West CR. Maximum and average urine flow rates in normal male and female populations--the Liverpool nomograms. Br J Urol. 1989 Jul;64(1):30-8. doi: 10.1111/j.1464-410x.1989.tb05518.x.
  PMID: 2765766
  citation: Mahdieh L, Zolaktaf V, Karimi MT. Effects of dynamic neuromuscular stabilization (DNS) training on functional movements. Hum Mov Sci. 2020 Apr;70:102568. doi: 10.1016/j.humov.2019.102568. Epub 2020 Jan 13.
  PMID: 31950895
  citation: Zivkovic V, Lazovic M, Vlajkovic M, Slavkovic A, Dimitrijevic L, Stankovic I, Vacic N. Diaphragmatic breathing exercises and pelvic floor retraining in children with dysfunctional voiding. Eur J Phys Rehabil Med. 2012 Sep;48(3):413-21. Epub 2012 Jun 5.
  PMID: 22669134
  responsible party type: Principal Investigator
  investigator affiliation: Halic University
  investigator full name: Duygu Şahin Altaç
  investigator title: Principal investigator, MSc, PT
  sharing ipd: No