Lower Urinary Tract Dysfunction

A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.

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.

Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Relaxation, as a core physiological and psychological state, has been shown to promote effective urine storage and facilitate smooth voiding. By repeatedly training individuals to establish a new conditioned reflex linking the sensation of urinary urgency with a state of relaxation, it may be possible to improve bladder storage capacity and voiding function. Based on this concept, the investigators have developed the world's first Micturition Desire-Relaxation Training Device (Chinese Patent No.: ZL 2020 1 0397789.4). This study aims to evaluate the clinical efficacy of this device in treating LUTD in children.