NCT06201013

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to investigate whether adding high-dose vitamin D (2,400 IU daily) to standard medical treatment (solifenacin combined with behavioral therapy) is more effective than standard treatment alone for children with overactive bladder-wet (OAB-wet). OAB-wet causes sudden urinary urges and frequent daytime or incontinence, which significantly impacts a child's quality of life and increases the family's caregiving burden. While solifenacin is a standard medication used to calm the bladder, many children do not achieve complete dryness. This study introduces the "Treat-to-Target" (T2T) approach, where clinicians and families set personalized "functional goals" (such as zero leakage) and monitor progress closely to adjust care. The study aims to answer the following questions: Does adding vitamin D help more children achieve their goal of "zero leakage" compared to standard treatment? Does vitamin D help repair bladder-related nerves, as measured by a specific marker in the urine? Does this combined approach reduce the family's expenses (like laundry costs and diaper use) and improve the child's self-esteem? Participants will be randomly assigned to one of two groups for 12 weeks: Intervention Group: Standard care (solifenacin + behavioral therapy) plus daily vitamin D (2,400 IU). Control Group: Standard care (solifenacin + behavioral therapy) alone. Researchers will evaluate symptoms, vitamin D levels, and nerve repair markers at 6 and 12 weeks to determine the best treatment strategy for these children.

Detailed description

This randomized controlled trial utilizes a "Treat-to-Target" (T2T) framework to evaluate the incremental value of high-dose vitamin D supplementation as an add-on therapy to standard anticholinergic treatment (solifenacin) for pediatric idiopathic overactive bladder-wet (OAB-wet). This study shifts the focus from simple symptom reduction to achieving predefined, patient-centered functional goals. While solifenacin targets the muscarinic receptors to inhibit detrusor overactivity (symptomatic relief), vitamin D is hypothesized to act as a neuromodulator that promotes neural repair-specifically the remyelination of pelvic nerves involved in bladder control.The study will enroll children with OAB-wet and documented vitamin D insufficiency/deficiency. The intervention group receives a multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3. The control group receives standard-of-care (solifenacin + SU).Key components of the study include:Goal Setting: At Week 0, clinicians and caregivers will establish a specific clinical target.Monitor and Adjust: At Week 6, serum 25(OH)D levels and voiding diaries will be reviewed to assess the trajectory toward the clinical target and the biochemical threshold of 40 ng/mL.Mechanism Validation: Urinary Myelin Basic Protein (uMBP) corrected by creatinine will be measured at baseline and Week6\&12 to provide evidence of structural neural repair.Value-Based Assessment: A health economic evaluation will compare the total societal cost (medication costs vs. reduced caregiver burden and laundry expenses) between the two strategies. By comparing these two pathways, the study aims to demonstrate that a multimodal T2T strategy incorporating vitamin D offers superior clinical achievement rates and better long-term functional outcomes than conventional pharmacological approaches.

Conditions

• Urinary Bladder, Overactive
• Overactive Bladder
• Urinary Incontinence, Urge

Interventions

Type	Name	Description
BEHAVIORAL	urotherapy	Participants were asked to undergo a 30-min session every 6 weeks at follow-up, including (1) education about the disease to dispel doubts about it and to understand the benefits of curing the dysfunction in order for the child to have a better therapeutic outcome, (2) urination at regular intervals and the establishment of good urination habits, (3) dietary instructions to avoid constipation, (4) accurate recording of symptoms of OAB, and (5) communication with the research team every 2 weeks.
DRUG	Solifenacin Succinate	In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
DRUG	Vitamin D3	In addition to urologic therapy, vitamin D drops containing 400 IU of vitamin D3 per capsule, 1,200 iu per oral dose, twice daily, for a total of 2,400 iu/d; serum vitamin D levels need to be rechecked at every 6-week follow-up visit

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-09-15
• Completion: 2027-04-15
• First posted: 2024-01-11
• Last updated: 2026-04-17

Locations

1 site across 1 country: China