Actively Recruiting
Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet
Led by Children's Hospital of Chongqing Medical University · Updated on 2026-04-17
180
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 18 years diagnosed with wet overactive bladder
- Serum vitamin D levels below 35 ng/ml
- Informed consent signed by guardians who can ensure compliance
You will not qualify if you...
- Urinary malformations or serious urinary diseases such as hypospadias or vesicoureteral reflux
- Neurological disorders including epilepsy, spinal cord injuries, or autism spectrum disorders
- Serious heart, liver, kidney, lung, bone, digestive, or genetic metabolic diseases
- History of gastrointestinal or urological surgery
- Chronic constipation or dry stools
- Use of anticonvulsant, antiepileptic, hormone, or anti-tuberculosis medications
- History of hypercalcemia, hyperphosphatemia with renal rickets
- Recent unexplained hematuria
- Severe heart disease or chronic diabetes
- Participation in other clinical studies during this study
- Unwillingness to participate in the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
Research Team
X
Xing Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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