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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysfunctional Voiding Other: Exercise Other: Standard therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding : A Randomized Clinical Trial
Actual Study Start Date : March 2, 2021
Actual Primary Completion Date : April 7, 2023
Actual Study Completion Date : June 21, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dynamic Neuromuscular Stabilisation Exercise
The participants performed DNS exercises addition to standard therapy
 Other: Exercise
Dynamic Neuromuscular Stabilisation Exercise

Other: Standard therapy
Patient education, massage, diaphragmatic breathing, kegel exercise
Standard therapy
Patient education, massage, diaphragmatic breathing, kegel exercise
 Other: Standard therapy
Patient education, massage, diaphragmatic breathing, kegel exercise


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040333


Locations
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Turkey
Haliç University
Istanbul, Turkey
Sponsors and Collaborators
Halic University
Investigators
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Study Director: Seda Saka, PhD Haliç University
More Information
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Publications of Results:

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Responsible Party: Duygu Şahin Altaç, Principal investigator, MSc, PT, Halic University
ClinicalTrials.gov Identifier: NCT06040333    
Other Study ID Numbers: ssaka8
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duygu Şahin Altaç, Halic University:
dysfunctional voiding
dynamic neuromuscular stabilization exercise