Evaluating a Relaxation Training Device to Treat Bladder Problems in Children Ages 5 to 18

What this Trial Is About

Lower urinary tract dysfunction LUTD in children involves problems with urine storage and voiding, often linked to abnormal reflexes formed in the central nervous system. Relaxation has been shown to help improve these functions. This trial evaluates a new Micturition Desire-Relaxation Training Device designed to help children with LUTD by training them to link the sensation of needing to urinate with a relaxed state. The study is a randomized controlled trial conducted over six months to assess the devices clinical effects. Participants are randomly assigned to either the intervention group using the active Micturition Desire-Relaxation Training Device or a sham group using an inactive device. In the intervention group, children will do supervised training sessions followed by home use of the device, performing 5 to 10 daily sessions lasting about 10 minutes each over eight weeks. The sham group follows the same training schedule but uses a non-functioning device for four weeks. Both groups maintain fluid intake and voiding diaries with monthly records, and caregivers receive remote support from study physicians. Throughout the study, participants complete voiding diaries and enuresis questionnaires at baseline, during treatment, and at 3 and 6 months post-intervention to monitor symptom changes and recurrence. Daily training adherence and any adverse events are recorded and reviewed by physicians through a secure cloud platform. The trial measures outcomes such as improvement rates in enuresis, daytime urinary incontinence frequency, total voiding episodes, and various bladder function and behavioral assessments, tracking progress over the full six-month period.

Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children