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

Inclusion Criteria3

  • 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.

Exclusion Criteria11

  • 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

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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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