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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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

Study 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

Primary outcome measure(s)

• Clinical Target Achievement Rate at 12 Weeks — week 12
  Percentage of participants who achieve their pre-defined personalized clinical goal set at Week 0.

Trial sites (1)

More Children's Hospital of Chongqing Medical University trials in China

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