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
Overview
- Phase
- Not Applicable
- Intervention
- Pelvic floor muscle training with ultrasound biofeedback
- Conditions
- Dysfunctional Voiding
- Sponsor
- Izmir University of Economics
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in the amount of post-void residue
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Seda Yakit Yesilyurt
Assist. Prof.
Izmir University of Economics
Eligibility Criteria
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.
Arms & Interventions
DNS Group
This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.
Intervention: Pelvic floor muscle training with ultrasound biofeedback
DNS Group
This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.
Intervention: Dynamic neuromuscular stabilization exercise
Standard exercise group
This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.
Intervention: Pelvic floor muscle training with ultrasound biofeedback
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in EMG-Uroflowmetry measurements-uroflow curve(From enrollment to the end of treatment at 8 week)
- Change in EMG-Uroflowmetry measurements - Voided volume(From enrollment to the end of treatment at 8 weeks)
- Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)(6 months after treatment)
- Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)(6 months after treatment)
- Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)(6 months after treatment)
- Gross Motor Development Stages(at baseline)
- Change in symptom severity(6 months after treatment)
- Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)(From enrollment to the end of treatment at 8 weeks)
- Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)(From enrollment to the end of treatment at 8 weeks)
- Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)(From enrollment to the end of treatment at 8 weeks)
- Change in symptom severity(From enrollment to the end of treatment at 8 weeks)