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Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding

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ClinicalTrials.gov Identifier: NCT06040333
Recruitment Status : Completed
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Duygu Şahin Altaç, Halic University

Tracking Information
First Submitted Date  ICMJE August 29, 2023
First Posted Date  ICMJE September 15, 2023
Last Update Posted Date September 15, 2023
Actual Study Start Date  ICMJE March 2, 2021
Actual Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2023)
  • Uroflowmetry - Maximum flow rate (Qmax) [ Time Frame: at the baseline and at week 6. ]
    Uroflowmetry gives information about urine flow rate and voiding pattern. *Qmax (mL/s): Qmax is the fastest stream measured in mL/s.
  • Uroflowmetry - Average flow rate (Qave) [ Time Frame: at the baseline and at week 6. ]
    Uroflowmetry gives information about urine flow rate and voiding pattern. *Qave (mL/s): Qave is the average stream measured in mL/s.
  • Uroflowmetry - Corrected maximum flow rate (cQmax) [ Time Frame: at the baseline and at week 6. ]
    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.
  • Uroflowmetry - Flow time (FT) [ Time Frame: at the baseline and at week 6. ]
    Uroflowmetry gives information about urine flow rate and voiding pattern. *FT (s): FT is the time over which measurable flow actually occurs.
  • Uroflowmetry - Voiding volume (VV) [ Time Frame: at the baseline and at week 6. ]
    Uroflowmetry gives information about urine flow rate and voiding pattern. *VV (ml): VV indicates the amount of voiding.
  • Uroflowmetry - Residual urine (RU) [ Time Frame: at the baseline and at week 6. ]
    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.
  • Dysfunctional Voiding and Incontinence Symptom Score [ Time Frame: at the baseline and at week 6. ]
    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.
  • Short Form 36 [ Time Frame: at the baseline and at week 6. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding
Official Title  ICMJE The Effect of Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding : A Randomized Clinical Trial
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Dysfunctional Voiding
Intervention  ICMJE
  • Other: Exercise
    Dynamic Neuromuscular Stabilisation Exercise
  • Other: Standard therapy
    Patient education, massage, diaphragmatic breathing, kegel exercise
Study Arms  ICMJE
  • Experimental: Dynamic Neuromuscular Stabilisation Exercise
    The participants performed DNS exercises addition to standard therapy
    Interventions:
    • Other: Exercise
    • Other: Standard therapy
  • Standard therapy
    Patient education, massage, diaphragmatic breathing, kegel exercise
    Intervention: Other: Standard therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2023)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 21, 2023
Actual Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Having been diagnosed with dysfunctional voiding,
  • Being between the ages of 18-75,
  • Not having a neurogenic bladder
  • Not having a urinary tract infection
  • Not having an obstacle to exercise,
  • Accepting and signing the Approval Form,
  • Not having undergone surgery in the last 6 months,

Exclusion Criteria:

  • Not being cooperative
  • Not being able to participate in the treatment,
  • The use of drugs that will affect urination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06040333
Other Study ID Numbers  ICMJE ssaka8
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duygu Şahin Altaç, Halic University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Halic University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Seda Saka, PhD Haliç University
PRS Account Halic University
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP