Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether adding high-dose vitamin D (2,400 IU daily) to the usual medical treatment of solifenacin combined with behavioral therapy improves outcomes for children with overactive bladder-wet (OAB-wet). OAB-wet causes sudden urges to urinate and frequent daytime wetting or incontinence, affecting children's quality of life and increasing caregiving demands. The study uses a Treat-to-Target (T2T) approach where families and clinicians set personalized goals like zero leakage and closely monitor progress to adjust care. Participants are randomly assigned to two groups for 12 weeks. One group receives standard care with solifenacin and behavioral therapy. The other group receives the same standard care plus daily vitamin D supplementation. Follow-up visits occur every 6 weeks to review vitamin D levels, urinary symptoms, and markers of nerve repair. The T2T strategy aims to improve treatment by focusing on nerve healing and reducing symptoms and family costs. During the study, participants will have assessments including urinary diaries, vitamin D blood tests, and urine tests measuring nerve repair markers at baseline, 6 weeks, and 12 weeks. Researchers will also evaluate quality of life and economic impact on families by tracking expenses like laundry and diapers. The main outcome is the rate of achieving the personalized clinical target of zero leakage at 12 weeks. The study lasts about 3 months with careful monitoring and adjustments based on progress.

Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet