Dysfunctional VoidingNCT06743165
New Generation Rehabilitation Approach in Children With Dysfunctional Voiding
A study testing Pelvic floor muscle training with ultrasound biofeedback and Dynamic neuromuscular stabilization exercise in people with Dysfunctional Voiding and Children, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypothesize that Dynamic Neuromuscular Stabilization training, a next-generation exercise approach, and transabdominal ultrasound-guided pelvic floor muscle training (PFMT) will be more effective than PFMT guided solely by transabdominal ultrasound in reducing post-void residual volume, improving… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dysfunctional Voiding, Children, Pelvic Floor Muscle Training
- What is being tested?
- Pelvic floor muscle training with ultrasound biofeedback and Dynamic neuromuscular stabilization exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Mar 2026
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-14 years,
- Diagnosed with dysfunctional urination according to uroflowmetry measurement results and clinical examination findings,
- Children who consent to participate in the study with the consent of their mother, father or legal guardian (legal representative) will be included in the study.
Who cannot join
- Children under 6 years of age,
- Those with anatomical changes in the urinary system,
- Those with spina bifida,
- Those with a history of active urinary tract infection,
- Those with a neurological disease,
- Those with accompanying respiratory system disease,
Show all 13Show fewer
- Those with cognitive impairment,
- Those with mental retardation,
- Children whose bladder image is unclear in the pelvic floor evaluation with US,
- Children who have previously undergone orthopedic surgery will not be included in the study.
- PS:
- Children who cannot comply with the application of pelvic floor muscle training,
- Children who have missed 2 or more sessions of the treatment program will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: New Generation Rehabilitation Approach in Children With Dysfunctional Voiding: Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Training With Transabdominal Ultrasound, a Randomized Controlled Trial
The investigators hypothesize that Dynamic Neuromuscular Stabilization training, a next-generation exercise approach, and transabdominal ultrasound-guided pelvic floor muscle training (PFMT) will be more effective than PFMT guided solely by transabdominal ultrasound in reducing post-void residual volume, improving voiding disorder symptoms, and enhancing pelvic floor muscle relaxation in children with dysfunctional voiding.
- Conditions
- Dysfunctional Voiding, Children, Pelvic Floor Muscle Training, Ultrasound, DNS
- Being tested
- Pelvic floor muscle training with ultrasound biofeedback, Dynamic neuromuscular stabilization exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training with ultrasound biofeedbackBehavioural
Pelvic floor muscle training (PFMT) will be given to both groups with transabdominal US. PFMT will be applied by physiotherapists who have received training and supervision from physiotherapists who are experts in the field of pelvic floor US imaging and pelvic floor muscle training with US. Pelvic floor muscle training will be applied with a GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) US device under the supervision of an expert physiotherapist. Parents and children will be informed about PFMT.
Dynamic neuromuscular stabilization exerciseBehavioural
Dynamic neuromuscular exercises (DNS) involve the joint activation of the intrinsic muscle group of the spine, which includes the cervical flexors and extensors, diaphragm, transversus abdominis, multifidus and pelvic floor, which form the integrated spinal stabilization system. The application principles are joint centering, core stabilization - Integrated spinal stabilization system and stabilization function of the diaphragm. DNS training will be applied in three stages. Preparation for exercises, IAB regulation and application of exercises according to developmental kinesiology positions. Exercises will start with preparatory training. In preparatory training, stroking, brushing and tapping techniques will be taught and self-facilitation will be demonstrated in order to increase proprioceptive input to the lower extremity, upper extremity, trunk and pelvic region. Fascial mobilizations will be performed to the foot and hand regions.
| Study group | Role | What they receive |
|---|---|---|
| DNS Group | Experimental | This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years. Receives: Behavioral: Pelvic floor muscle training with ultrasound biofeedback; Behavioral: Dynamic neuromuscular stabilization exercise |
| Standard exercise group | Active comparator | This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years. Receives: Behavioral: Pelvic floor muscle training with ultrasound biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of post-void residue
After EMG-Uroflowmetry test: Post-void residual measurement will be made by transabdominal ultrasound 5 minutes after voiding. In repeated measurements, the amount of urine remaining in the bladder of 20 ml or more will be considered pathological.
Measured: From enrollment to the end of treatment at 8 weeks
Change in EMG-Uroflowmetry measurements-peak flow rate
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Voided volume (ml), peak flow rate (Q max, ml/sec) and uroflow curve interpretation will also be used. Those with decreased flow rate and stacco/interminant flow pattern will be considered pathological.
Measured: From enrollment to the end of treatment at 8 weeks
Change in EMG-Uroflowmetry measurements-Pelvic Floor EMG activity
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Recorded as (µV).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (11)
Change in EMG-Uroflowmetry measurements-uroflow curve
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Voided volume (ml), peak flow rate (Q max, ml/sec) and uroflow curve interpretation will also be used. Those with decreased flow rate and stacco/interminant flow pattern will be considered pathological.
Measured: From enrollment to the end of treatment at 8 week
Change in EMG-Uroflowmetry measurements - Voided volume
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Voided volume (ml), peak flow rate (Q max, ml/sec) and uroflow curve interpretation will also be used. Those with decreased flow rate and stacco/interminant flow pattern will be considered pathological.
Measured: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: From enrollment to the end of treatment at 8 weeks
Gross Motor Development Stages
Children's gross motor development stages will be questioned in accordance with the protocol determined by the World Health Organization. The children's time to sit without support, stand with support, crawl, walk with help, stand alone and walk alone will be noted in months.
Measured: at baseline
Change in symptom severity
The severity of children's voiding disorder symptoms will be assessed with the Voiding Disorders Symptom Score. The Voiding Disorders Symptom Score was developed by Akbal et al in 2005 and consists of a total of 14 questions. The 13 questions of the questionnaire evaluate symptoms related to daytime urinary incontinence, symptoms related to nighttime urinary incontinence, frequency of urination in a day, presence of constipation and various symptoms related to urinary incontinence.
Measured: From enrollment to the end of treatment at 8 weeks
Change in symptom severity
The severity of children's voiding disorder symptoms will be assessed with the Voiding Disorders Symptom Score. The Voiding Disorders Symptom Score was developed by Akbal et al in 2005 and consists of a total of 14 questions. The 13 questions of the questionnaire evaluate symptoms related to daytime urinary incontinence, symptoms related to nighttime urinary incontinence, frequency of urination in a day, presence of constipation and various symptoms related to urinary incontinence.
Measured: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
Assessment procedure: Pelvic floor assessment will be performed with transabdominal US. In order for imaging to be performed properly during ultrasound measurement, the child will be asked to consume 250 ml of a caffeine-free liquid before measurement. The measurement will be performed in the lying position with a 2-5 MHz GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) device in accordance with the protocols in Bo and Bower's studies. In this measurement, a fixed point will be determined at the base of the bladder and the displacement of this fixed point will be taken as basis during pelvic floor muscle assessment.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional VoidingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
- Investigators
- Seda Yakıt Yeşilyurt, Asst. Prof., Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743165
- Sponsor's protocol ID
- SYY_IEU_4
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since no consent has been received from the institutions supporting this project to share the data with third parties, it will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Generation Rehabilitation Approach in Children With Dysfunctional Voiding: Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Training With Transabdominal Ultrasound, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06743165
- Acronym / sponsor ID
- SYY_IEU_4
- Conditions
- Dysfunctional Voiding, Children, Pelvic Floor Muscle Training, Ultrasound, DNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that Dynamic Neuromuscular Stabilization training, a next-generation exercise approach, and transabdominal ultrasound-guided pelvic floor muscle training (PFMT) will be more effective than PFMT guided solely by transabdominal ultrasound in reducing post-void residual volume, improving voiding disorder symptoms, and enhancing pelvic floor muscle relaxation in children with dysfunctional voiding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNS Group | Experimental | Behavioral: Pelvic floor muscle training with ultrasound biofeedback, Behavioral: Dynamic neuromuscular stabilization exerciseThis group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years. |
| Standard exercise group | Active comparator | Behavioral: Pelvic floor muscle training with ultrasound biofeedbackThis group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-14 years,
- Diagnosed with dysfunctional urination according to uroflowmetry measurement results and clinical examination findings,
- Children who consent to participate in the study with the consent of their mother, father or legal guardian (legal representative) will be included in the study.
Key exclusion criteria (13 listed)
- Children under 6 years of age,
- Those with anatomical changes in the urinary system,
- Those with spina bifida,
- Those with a history of active urinary tract infection,
- Those with a neurological disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training with ultrasound biofeedbackPelvic floor muscle training (PFMT) will be given to both groups with transabdominal US. PFMT will be applied by physiotherapists who have received training and supervision from physiotherapists who are experts in the field of pelvic floor US imaging and pelvic floor muscle training with US. Pelvic floor muscle training will be applied with a GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) US device under the supervision of an expert physiotherapist. Parents and children will be informed about PFMT. | Behavioural | DNS Group, Standard exercise group |
| Dynamic neuromuscular stabilization exerciseDynamic neuromuscular exercises (DNS) involve the joint activation of the intrinsic muscle group of the spine, which includes the cervical flexors and extensors, diaphragm, transversus abdominis, multifidus and pelvic floor, which form the integrated spinal stabilization system. The application principles are joint centering, core stabilization - Integrated spinal stabilization system and stabilization function of the diaphragm. DNS training will be applied in three stages. Preparation for exercises, IAB regulation and application of exercises according to developmental kinesiology positions. Exercises will start with preparatory training. In preparatory training, stroking, brushing and tapping techniques will be taught and self-facilitation will be demonstrated in order to increase proprioceptive input to the lower extremity, upper extremity, trunk and pelvic region. Fascial mobilizations will be performed to the foot and hand regions. | Behavioural | DNS Group |
Primary outcome
Change in the amount of post-void residue
Time frame: From enrollment to the end of treatment at 8 weeks
After EMG-Uroflowmetry test: Post-void residual measurement will be made by transabdominal ultrasound 5 minutes after voiding. In repeated measurements, the amount of urine remaining in the bladder of 20 ml or more will be considered pathological.
Change in EMG-Uroflowmetry measurements-peak flow rate
Time frame: From enrollment to the end of treatment at 8 weeks
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Voided volume (ml), peak flow rate (Q max, ml/sec) and uroflow curve interpretation will also be used. Those with decreased flow rate and stacco/interminant flow pattern will be considered pathological.
Change in EMG-Uroflowmetry measurements-Pelvic Floor EMG activity
Time frame: From enrollment to the end of treatment at 8 weeks
EMG-Uroflowmetry test procedure: Before the test, the device will be calibrated and the scale of the interpretation sheet will be set to 1:1 for flow rate (ml/sec) and time (sec). The test will be performed in a quiet and private room and the patient will be asked to drink as much fluid as the expected bladder capacity ((age in years+1)x30) 1 hour before the test. During the test, the EMG activity of the pelvic floor muscles will also be evaluated. Recorded as (µV).
11 secondary outcomes
Change in EMG-Uroflowmetry measurements-uroflow curve
Time frame: From enrollment to the end of treatment at 8 week
Change in EMG-Uroflowmetry measurements - Voided volume
Time frame: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
Time frame: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
Time frame: From enrollment to the end of treatment at 8 weeks
Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
Time frame: From enrollment to the end of treatment at 8 weeks
Gross Motor Development Stages
Time frame: at baseline
Change in symptom severity
Time frame: From enrollment to the end of treatment at 8 weeks
Change in symptom severity
Time frame: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
Time frame: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
Time frame: 6 months after treatment
Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Since no consent has been received from the institutions supporting this project to share the data with third parties, it will not be shared.
Related trials for Dysfunctional Voiding
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Local Injection, Botulinium Toxin-A
Active, not recruitingObservational study
Biofeedback for Dysfunctional Voiding and Giggle Incontinence
Biofeedback Therapy, Dysfunctional Voiding
Not yet recruiting
Use of an Educational Video to Improve Adherence to Treatment in Voiding Dysfunction
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Not yet recruitingObservational study
Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Yakıt Yeşilyurt, Asst. Prof. principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training with ultrasound biofeedback and Dynamic neuromuscular stabilization exercise in people with Dysfunctional Voiding and Children, run by Izmir University of Economics 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 3 inclusion and 13 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 1 Sep 2026. 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?
Change in the amount of post-void residue (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.