Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorChildren's Hospital of Chongqing Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
urotherapy
BehavioralParticipants 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
DrugIn addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
Vitamin D3
DrugIn 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
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Standard-of-careActive comparator 2 interventions
Group B: Multimodal strategyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Clinical Target Achievement Rate at 12 Weeks
Percentage of participants who achieve their pre-defined personalized clinical goal set at Week 0.
Time frame
week 12Secondary outcomes
1
Change in Weekly Urinary Incontinence (UI) Frequency
Change from baseline in the number of urinary incontinence episodes per week. Data is collected via a parent-reported voiding diary.
Time frame
Baseline, 6 weeks, 12 weeks.2
Change in Pediatric Incontinence Questionnaire (PIN-Q) Score
The PIN-Q is a validated tool to assess health-related quality of life (QoL) in children with bladder dysfunction. It contains 20 items (range 0-80); a higher score represents a poorer quality of life.
Time frame
Baseline, 12 weeks.3
Change in Pediatric Lower Urinary Tract Symptom (PLUTS) Score
Evaluation of the severity of lower urinary tract symptoms using the validated PLUTS scale. It assesses frequency, urgency, and other voiding symptoms.
Time frame
Baseline, 6 weeks, 12 weeks.4
Health Economics: Total Household Burden Cost
Evaluation of the total direct and indirect costs related to incontinence care, including medication expenses, laundry costs (water, detergent), consumption of absorbent pads/diapers, and estimated caregiver time loss.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov