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

Recruiting now · Not applicable

Conditions studied: Urinary Bladder, Overactive, Overactive Bladder, Urinary Incontinence, Urge

In brief

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.

Key facts

Study ID: NCT06201013
Run by: Children's Hospital of Chongqing Medical University
People needed: 180
Starts: 2026-04-20
Expected to finish: 2027-04-15
Last updated by the study team: 2026-04-17

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children older than or equal to 5 years of age with a diagnosis of wet OAB (the diagnosis followed the latest guidelines of ICCS) attending the outpatient clinic of the Department of Urology of the Affiliated Children's Hospital of Chongqing Medical University,
children with serum vitamin D levels below 35 ng/ml as indicated by the tests conducted by the hospital
children whose guardians have given their informed consent, are able to ensure compliance and have signed a paper-based informed consent form.

You may not qualify if…

Those with urinary malformations or serious diseases (e.g., hypospadias, cryptorchidism, posterior urethral valvulae, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, bladder and urethral injuries, etc.)
Those with neurological disorders (e.g., epilepsy, spinal cord injuries, spinal dysplasia, spinal embolism syndrome, multiple sclerosis, and autism spectrum disorders, etc.)
People with serious heart disease, abnormal liver and kidney function, lung disease, bone deformity, serious digestive tract disease, genetic metabolic disease
People with history of gastrointestinal surgery and urological surgery
People with dry stools and long-term constipation
People who are taking anticonvulsant and antiepileptic drugs, hormones, and anti-tuberculosis drugs
People with history of hypercalcemia, hyperphosphatemia with renal rickets
People who have had unexplained hematuria and hematuria with renal rickets within the last year
People who have been suffering from severe heart disease or chronic diabetes.
participation in other clinical studies at the time of consultation or during the follow-up period of other clinical studies
unwillingness to participate in this study

Where it is running

Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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