An interventional study of urotherapy and Solifenacin Succinate in Urinary Bladder, Overactive, Overactive Bladder and Urinary Incontinence, Urge, sponsored by Children's Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Children's Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
This randomized controlled trial utilizes a "Treat-to-Target" (T2T) framework to evaluate the incremental value of high-dose vitamin D supplementation as an add-on therapy to standard anticholinergic treatment (solifenacin) for pediatric idiopathic overactive bladder-wet (OAB-wet).
This study shifts the focus from simple symptom reduction to achieving predefined, patient-centered functional goals. While solifenacin targets the muscarinic receptors to inhibit detrusor overactivity (symptomatic relief), vitamin D is hypothesized to act as a neuromodulator that promotes neural repair-specifically the remyelination of pelvic nerves involved in bladder control.The study will enroll children with OAB-wet and documented vitamin D insufficiency/deficiency. The intervention group receives a multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3. The control group receives standard-of-care (solifenacin + SU).Key components of the study include:Goal Setting: At Week 0, clinicians and caregivers will establish a specific clinical target.Monitor and Adjust: At Week 6, serum 25(OH)D levels and voiding diaries will be reviewed to assess the trajectory toward the clinical target and the biochemical threshold of 40 ng/mL.Mechanism Validation: Urinary Myelin Basic Protein (uMBP) corrected by creatinine will be measured at baseline and Week6\&12 to provide evidence of structural neural repair.Value-Based Assessment: A health economic evaluation will compare the total societal cost (medication costs vs. reduced caregiver burden and laundry expenses) between the two strategies.
By comparing these two pathways, the study aims to demonstrate that a multimodal T2T strategy incorporating vitamin D offers superior clinical achievement rates and better long-term functional outcomes than conventional pharmacological approaches.
Exclusion Criteria:
Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day
Behavioral: urotherapy · Drug: Solifenacin Succinate
A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3
Behavioral: urotherapy · Drug: Vitamin D3
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.
In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
Also known as: andard Urotherapy Combined with Solifenacin Drug Treatment
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
Also known as: Standard Urotherapy Combined with Vitamin D supplementation
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 12
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.
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.
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.
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 weeks
Change in Urinary Myelin Basic Protein (uMBP)/Creatinine Ratio
To evaluate structural neural repair of the bladder-related nerves. Concentrations are normalized by urinary creatinine.
Time frame: Baseline, 12 weeks.
Plan to share: Undecided
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Children's Hospital of Chongqing Medical University