New Generation Rehabilitation Approach in Children With Dysfunctional Voiding

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Children; Ultrasound; Pelvic Floor Muscle Training; Dysfunctional Voiding; DNS
• Intervention / Treatment: Behavioral: Pelvic floor muscle training with ultrasound biofeedback; Behavioral: Dynamic neuromuscular stabilization exercise

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35330
    • Izmir University of Economics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

• 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,
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DNS Group; This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.	Behavioral: Pelvic floor muscle training with ultrasound biofeedback; 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.; Behavioral: Dynamic neuromuscular stabilization exercise; 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.
Active Comparator: Standard exercise group; This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.	Behavioral: Pelvic floor muscle training with ultrasound biofeedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 8 weeks
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.	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).	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months after treatment

Collaborators and Investigators

• Sponsor: Izmir University of Economics
• Collaborators: Health Institutes of Turkey
• Investigators: Principal Investigator: Seda Yakıt Yeşilyurt, Asst. Prof., Izmir University of Economics

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYY_IEU_4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since no consent has been received from the institutions supporting this project to share the data with third parties, it will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No