NCT06040333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

August 29, 2023

Last Update Submit

September 13, 2023

Conditions

Dysfunctional Voiding

Keywords

dysfunctional voidingdynamic neuromuscular stabilization exercise

Outcome Measures

Primary Outcomes (8)

  • Uroflowmetry - Maximum flow rate (Qmax)

    Uroflowmetry gives information about urine flow rate and voiding pattern. \*Qmax (mL/s): Qmax is the fastest stream measured in mL/s.

    at the baseline and at week 6.

  • Uroflowmetry - Average flow rate (Qave)

    Uroflowmetry gives information about urine flow rate and voiding pattern. \*Qave (mL/s): Qave is the average stream measured in mL/s.

    at the baseline and at week 6.

  • Uroflowmetry - Corrected maximum flow rate (cQmax)

    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.

    at the baseline and at week 6.

  • Uroflowmetry - Flow time (FT)

    Uroflowmetry gives information about urine flow rate and voiding pattern. \*FT (s): FT is the time over which measurable flow actually occurs.

    at the baseline and at week 6.

  • Uroflowmetry - Voiding volume (VV)

    Uroflowmetry gives information about urine flow rate and voiding pattern. \*VV (ml): VV indicates the amount of voiding.

    at the baseline and at week 6.

  • Uroflowmetry - Residual urine (RU)

    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.

    at the baseline and at week 6.

  • Dysfunctional Voiding and Incontinence Symptom Score

    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.

    at the baseline and at week 6.

  • Short Form 36

    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.

    at the baseline and at week 6.

Study Arms (2)

Dynamic Neuromuscular Stabilisation Exercise

EXPERIMENTAL

The participants performed DNS exercises addition to standard therapy

Other: ExerciseOther: Standard therapy

Standard therapy

OTHER

Patient education, massage, diaphragmatic breathing, kegel exercise

Other: Standard therapy

Interventions

ExerciseOTHER

Dynamic Neuromuscular Stabilisation Exercise

Dynamic Neuromuscular Stabilisation Exercise
Standard therapyOTHER

Patient education, massage, diaphragmatic breathing, kegel exercise

Dynamic Neuromuscular Stabilisation ExerciseStandard therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • Not being cooperative
  • Not being able to participate in the treatment,
  • The use of drugs that will affect urination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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: 15711352RESULT

  • 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: 30130020RESULT

  • 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: 25772695RESULT

  • 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: 2765766RESULT

  • 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: 31950895RESULT

  • 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: 22669134RESULT

MeSH Terms

Interventions

ExerciseStandard of Care

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Seda Saka, PhD

    Haliç University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MSc, PT

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 15, 2023

Study Start

March 2, 2021

Primary Completion

April 7, 2023

Study Completion

June 21, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)