About this trial
This study aims to investigate the effects of video game-based balance exercises, in addition to standard treatment, in children aged 5-12 years with lower urinary tract dysfunction (LUTD). The single-center study will include 30 children who will be randomly assigned to an experimental group (video game-based balance exercises + standard treatment) or a control group (standard treatment only). Children in the experimental group will play selected balance games using the Wii console and Wii Balance Board twice a week for 8 weeks.
All participants will receive the standard program consisting of urotherapy, diaphragmatic breathing exercises, biofeedback-assisted pelvic floor muscle training, and functional exercises. Outcomes will be assessed using a Bladder Diary, uroflowmetry, ultrasonography for post-void residual urine, pelvic floor muscle activity with EMG, the Dysfunctional Voiding and Incontinence Symptoms Score Questionnaire(DVISS), quality of life with the Pediatric Incontinence Quality of Life Questionnaire (PinQ), balance tests, the McGill Core Endurance Test, and the Physical Activity Enjoyment Scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being between 5 and 12 years of age
Having a diagnosis of "Lower Urinary Tract Dysfunction" made by a pediatric urologist according to the criteria defined by the ICCS
Voluntary participation of both the parent and the child in the study
Disqualifiers
Having any neurologically based condition
Presence of any condition in the parent or child that affects the ability to respond to the assessment tools (e.g., intellectual disability, developmental delay, cognitive problems)
Having any physical impairment (orthopedic, structural, etc.) that prevents the use of Wii-Fit
Presence of malformations or anatomical anomalies in the urinary tract system
Trial design
Parallel
Treatments tested in this trial
Urotherapy training
BehavioralStandard urotherapy consists of five main components aimed at regulating lower urinary tract (LUT) function in children: education about LUT function and dysfunction, establishing healthy voiding habits and behavioral modifications, lifestyle recommendations such as balanced fluid intake and nutrition, monitoring of symptoms and voiding habits, and consistent caregiver support. In contrast, specific urotherapy focuses on treating particular LUT dysfunctions and includes interventions such as alarm therapy, pelvic floor training, biofeedback, neuromodulation, and clean intermittent catheterization. All children and their caregivers participating in our study will receive urotherapy training prior to the pelvic floor rehabilitation interventions. Each urotherapy session will last approximately 60 minutes.
Diaphragmatic Breathing Exercise
Other interventionThe exercise will be performed under the supervision of a physiotherapist, twice a week for 8 weeks. After the correct position is established, participants will be instructed to slowly inhale through their nose and focus on feeling the breath move from top to bottom (cranial to caudal). They will be asked to hold their breath for a few seconds, then exhale slowly through pursed lips. Additionally, they will be reminded not to push only their abdomen upward while inhaling, but to feel the intra-abdominal pressure expanding evenly in all directions (360 degrees). This exercise will be performed in 3 sets of 10 repetitions.
Biofeedback-Assisted Pelvic Floor Muscle Exercises
Other interventionNo invasive procedures will be performed. The physiotherapist will begin with external palpation of the perineal area to teach correct pelvic floor contractions without using accessory muscles. Once the patient masters this, animation-supported biofeedback exercises will start. If relaxation is insufficient, biofeedback will first target muscle relaxation. Using the NeuroTrac Myoplus Pro4 device, surface electrodes will be placed at 2 and 7 o'clock on the perineum, and the reference electrode on the right thigh. Exercises will start in a lying position and progress to sitting and standing as control improves. Each session will last about 20 min, with 2-5 s contractions followed by 5-10 s relaxations.
Video Game-Based Balance Exercise Training
Other interventionIn our study, in addition to the standard protocol, virtual reality-supported video game-based balance exercises will be performed twice a week for 8 weeks. Each session will include a 5-minute warm-up, 20 minutes of balance exercises, and a 5-minute cool-down period. All sessions will follow the same protocol, with identical game order and duration. Each game will be played for approximately 5 minutes, and the number of repetitions for each game will vary depending on the participant's performance level. As a therapeutic tool, the Wii console, Wii Fit Plus game disc, and Wii Balance Board will be used. The selected exercise games will include Hula Hoop Plus, Penguin Slide, Soccer Heading, Table Tilt, Tightrope Walk, Ski Jump, and Step Up.
Functional Exercise Training
Other interventionOur study will include exercises aimed at improving core stabilization, dynamic neuromuscular control, and pelvic mobility. Exercise selection will be tailored to individual needs, and the number of repetitions and duration will be adjusted based on the participant's progress. Preferred exercises will include movements such as bridge, dead bug, bilateral arm and leg lift, bear position, cat-camel, and pelvic clock.
Treatment groups
Trial outcomes
Primary outcomes
Patient Follow-up Form
All participants' age (years), body weight (kg), and height (m) data will be recorded. For the measurement of body weight and height, devices manufactured by Seca will be used. Body mass index (BMI) will be calculated by dividing body weight by the square of height and will be expressed in kg/m². During face-to-face interviews, the pediatric urologist will obtain detailed information from the families and children regarding medication use, surgical history, cognitive and mental status, neurological or anatomical problems, and clinical symptoms. Clinical symptoms to be evaluated by the pediatric urologist will include urgency, frequency, straining, daytime incontinence, enuresis, urinary tract infection (UTI), hesitancy, pain during urination, intermittent voiding, feeling of incomplete bladder emptying, and voiding postponement behaviors. The results of all other assessment methods used in the study will also be recorded in this form.
Uroflowmetry
Uroflowmetry is an essential test for children with lower urinary tract dysfunction (LUTD). It is easy to perform, non-invasive, and quick, providing important data such as voided volume, voiding time, maximum flow rate, curve pattern, and flow rate. In our study, uroflowmetry will be performed using a device manufactured by AYMED®. Before the clinical visit, parents will be informed that the child should consume an adequate amount of non-irritating fluids. They will also be instructed that excessive and rapid fluid intake should be avoided to ensure the child reaches the desired bladder fullness in a healthy manner. The test will be performed when the child feels the urge to void. If the child's feet do not reach the ground, a footstool will be placed under their feet to eliminate the possibility of pelvic floor muscle contraction due to lack of support.
Post-Void Residual (PVR) Urine Measurement
Post-void residual (PVR) urine is defined as the amount of urine remaining in the bladder after voiding. PVR is an important parameter for evaluating voiding dysfunction and is considered a risk factor for urinary tract infections (UTIs). The volume of PVR should ideally be measured within the first 5 minutes after voiding, and optimally within \<1 minute. According to the standardization published by the International Children's Continence Society (ICCS), a PVR greater than 30 mL or more than 21% of bladder capacity is considered significant in children aged 4-6 years. In children aged 7-12 years, a PVR greater than 20 mL or more than 15% of bladder capacity is considered significant. In our study, PVR will be measured immediately after the uroflowmetry test by a pediatric urologist using a transabdominal ultrasound device (Telemed®) through the suprapubic region. This technique is preferred because it is non-invasive.
Bladder Diary
The bladder diary is one of the most valuable tools designed to assess lower urinary tract symptoms in daily clinical practice due to its simplicity and low cost. According to the standardization published by the International Children's Continence Society (ICCS), a minimum of 48-hour bladder diary should be completed when evaluating a child with lower urinary tract dysfunction (LUTD). The bladder diary includes data such as voiding frequency and volume, fluid intake, and drinking habits. In this diary, the child's voiding frequency, voided volume, fluid intake, and any episodes of daytime urinary incontinence will be recorded. Fluid intake and voided volume will be documented in milliliters (mL), and voiding duration will be recorded in seconds (s). Additionally, the child's sensation of urgency while voiding will be noted using categorical descriptors such as "none," "mild," "moderate," or "severe."
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