New Generation Rehabilitation Approach in Children With Dysfunctional Voiding

NCT06743165 | Active Not Recruiting

• 1 other identifier: SYY_IEU_4
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysfunctional Voiding; Pelvic Floor Muscle Training; Ultrasound; DNS; Children

Outcome Measures

Primary Outcomes (3)

• 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-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 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 Outcomes (11)

• 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)

  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

Study Arms (2)

DNS Group

EXPERIMENTAL

This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.

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.

Behavioral: Pelvic floor muscle training with ultrasound biofeedback

Interventions

Pelvic floor muscle training with ultrasound biofeedback BEHAVIORAL

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.

DNS Group; Standard exercise group

Dynamic neuromuscular stabilization exercise BEHAVIORAL

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.

DNS Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir University of Economics: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Izmir University of Economics

Izmir, 35330, Turkey (Türkiye)

Location

Study Officials

• Seda Yakıt Yeşilyurt, Asst. Prof.

  Izmir University of Economics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)