RecruitingNot ApplicableNCT06201013

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


Sponsor

Children's Hospital of Chongqing Medical University

Enrollment

180 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Solifenacin Succinate, a drug called Vitamin D3, and others for people with overactive bladder, urinary bladder, overactive, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALurotherapy

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.

DRUGSolifenacin Succinate

In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day

DRUGVitamin 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


Locations(1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06201013


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