Clinical trial NCT06743165: New Generation Rehabilitation Approach in Children With Dysfunctional Voiding
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysfunctional Voiding
Children
Pelvic Floor Muscle Training
Ultrasound
DNS
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2024-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: Change in the amount of post-void residue
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Change in EMG-Uroflowmetry measurements-peak flow rate
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change in EMG-Uroflowmetry measurements-uroflow curve
timeFrame: From enrollment to the end of treatment at 8 week
measure: Change in EMG-Uroflowmetry measurements - Voided volume
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Gross Motor Development Stages
timeFrame: at baseline
measure: Change in symptom severity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change in symptom severity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change in symptom severity
timeFrame: 6 months after treatment
measure: Change in symptom severity
timeFrame: 6 months after treatment
measure: Pelvic floor muscle assessment with ultrasound - maximum displacement (cm)
timeFrame: 6 months after treatment
measure: Pelvic floor muscle assessment with ultrasound - coordination amplitude (cm)
timeFrame: 6 months after treatment
measure: Pelvic floor muscle assessment with ultrasound - endurance amplitude (%)
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir University of Economics
Study officials:
References: