Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding

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

Tracking Information

• First Submitted Date: August 29, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 15, 2023
• Actual Study Start Date: March 2, 2021
• Actual Primary Completion Date: April 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Dysfunctional Voiding

Intervention

• Other: Exercise
  Dynamic Neuromuscular Stabilisation Exercise
• Other: Standard therapy
  Patient education, massage, diaphragmatic breathing, kegel exercise

Study Arms

• 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 *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2023): 34
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 21, 2023
• Actual Primary Completion Date: April 7, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06040333
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Duygu Şahin Altaç, Halic University
• Original Responsible Party: Same as current
• Current Study Sponsor: Halic University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Seda Saka, PhD; Haliç University

• PRS Account: Halic University
• Verification Date: September 2023