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

Sponsor
Children's Hospital of Chongqing Medical University
Study ID
NCT06201013
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • urotherapy — BEHAVIORAL
    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 — DRUG
    In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
  • Vitamin D3 — DRUG
    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 Details

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 Dates

First listed
Jan 11, 2024
Start date
Apr 20, 2026
Status verified
Mar 2026
Primary completion
Sep 15, 2026
Completion
Apr 15, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard-of-care
    Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day
  • Experimental: Multimodal strategy
    A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3

Primary Outcome Measure

Clinical Target Achievement Rate at 12 Weeks [ Time Frame: week 12 ]

Central Contacts

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