- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06040333
Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding
The Effect of Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding : A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Haliç University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dynamic Neuromuscular Stabilisation Exercise
The participants performed DNS exercises addition to standard therapy
|
Dynamic Neuromuscular Stabilisation Exercise
Patient education, massage, diaphragmatic breathing, kegel exercise
|
Other: Standard therapy
Patient education, massage, diaphragmatic breathing, kegel exercise
|
Patient education, massage, diaphragmatic breathing, kegel exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
at the baseline and at week 6.
|
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. |
at the baseline and at week 6.
|
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. |
at the baseline and at week 6.
|
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. |
at the baseline and at week 6.
|
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. |
at the baseline and at week 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. |
at the baseline and at week 6.
|
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.
|
at the baseline and at week 6.
|
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.
|
at the baseline and at week 6.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seda Saka, PhD, Haliç University
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ssaka8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysfunctional Voiding
-
Buddhist Tzu Chi General HospitalCompleted
-
University of NisNot yet recruitingDiaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional VoidingDysfunctional VoidingSerbia
-
Seoul National University HospitalActive, not recruitingBowel Dysfunction | Bladder Dysfunction | Pediatric Urology | Dysfunctional VoidingKorea, Republic of
-
University of Massachusetts, WorcesterCompletedPostoperative Pain | Dysfunctional VoidingUnited States
-
Duke UniversityNot yet recruitingUrinary Dysfunction | Dysfunctional Voiding
-
Nemours Children's ClinicTerminatedDysfunctional Voiding | Neurogenic IncontinenceUnited States
-
Yale UniversityButterfly Network, IncCompletedVoiding Disorders | Voiding DysfunctionUnited States
-
University of RochesterTerminatedVoiding DysfunctionUnited States
-
Genentech, Inc.CompletedDysfunctional Hemodialysis Catheters
-
Wellspect HealthCareWellspect HealthCareTerminatedBladder Voiding DysfunctionGermany
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown