New Generation Rehabilitation Approach in Children With Dysfunctional Voiding

Not Applicable

Recruiting

• Conditions: Dysfunctional Voiding; Children; Pelvic Floor Muscle Training; Ultrasound; DNS

• Registration Number: NCT06743165
• Lead Sponsor: Izmir University of Economics

Brief 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 voiding disorder symptoms, and enhancing pelvic floor muscle relaxation in children with dysfunctional voiding.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Study Start: 2025-02-01
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the amount of post-void residue	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.

Secondary Outcome Measures

Name	Time	Method
Change in EMG-Uroflowmetry measurements-peak flow rate	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-uroflow curve	From enrollment to the end of treatment at 8 week	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 - Voided volume	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.
Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)	6 months after treatment	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.
Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)	6 months after treatment	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.
Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)	6 months after treatment	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.
Gross Motor Development Stages	at baseline	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.
Change in symptom severity	6 months after treatment	The severity of children's bladder and bowel dysfunction symptoms will be assessed with the Bladder and Bowel Dysfunction Scale. The MBDS was developed by Afshar et al in 2009. The scale consists of 14 questions. The first 13 questions are specific to bladder and bowel dysfunction symptoms. The last question questions the degree of difficulty of completing the questionnaire. Each question is a 5-point Likert type and the last question is not added to the scoring. The total score varies between 0-52 and an increase in the score means an increase in symptom severity.

Trial Locations

Locations (1)

Izmir University of Economics; 🇹🇷 Izmir, Turkey