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Dysfunctional VoidingNCT06040333

Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding

A study testing Exercise and Standard therapy in people with Dysfunctional Voiding, run by Halic University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dysfunctional Voiding
What is being tested?
Exercise and Standard therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Mar 2021to 21 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Haliç University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding : A Randomized Clinical Trial

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.

Read the 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.

Being tested
Exercise, Standard therapy
Keywords
dysfunctional voiding, dynamic neuromuscular stabilization exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Dynamic Neuromuscular Stabilisation Exercise

  • Standard therapyOther

    Patient education, massage, diaphragmatic breathing, kegel exercise

Study groups in NCT06040333
Study groupRoleWhat they receive
Dynamic Neuromuscular Stabilisation ExerciseExperimentalThe participants performed DNS exercises addition to standard therapy
Receives: Other: Exercise; Other: Standard therapy
Standard therapyOtherPatient education, massage, diaphragmatic breathing, kegel exercise
Receives: Other: Standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at the baseline and at week 6.

  2. 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.

    Measured: at the baseline and at week 6.

  3. 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.

    Measured: at the baseline and at week 6.

  4. 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.

    Measured: at the baseline and at week 6.

  5. Uroflowmetry - Voiding volume (VV)

    Uroflowmetry gives information about urine flow rate and voiding pattern.

    *VV (ml): VV indicates the amount of voiding.

    Measured: at the baseline and at week 6.

  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.

    Measured: at the baseline and at week 6.

  7. 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.

    Measured: at the baseline and at week 6.

  8. 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.

    Measured: at the baseline and at week 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start2 Mar 2021
  3. Primary completion7 Apr 2023
  4. Study completion21 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06040333
Sponsor's protocol ID
ssaka8
Status last verified
Sep 2023
First submitted
29 Aug 2023
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 15711352

  • 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.

    PubMed 30130020

  • 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.

    PubMed 25772695

  • 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.

    PubMed 2765766

  • 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.

    PubMed 31950895

  • 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.

    PubMed 22669134

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Standard therapy in people with Dysfunctional Voiding, run by Halic University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uroflowmetry - Maximum flow rate (Qmax) (time frame: at the baseline and at week 6.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06040333, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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