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

April 14, 2026 updated by: Xing Liu, Children's Hospital of Chongqing Medical University

Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400000
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • People with dry stools and long-term constipation
  • People who are taking anticonvulsant and antiepileptic drugs, hormones, and anti-tuberculosis drugs
  • People with history of hypercalcemia, hyperphosphatemia with renal rickets
  • People who have had unexplained hematuria and hematuria with renal rickets within the last year
  • People who have been suffering from severe heart disease or chronic diabetes.
  • participation in other clinical studies at the time of consultation or during the follow-up period of other clinical studies
  • unwillingness to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard-of-care
Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day
Behavioral: 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.
Drug: Solifenacin Succinate
In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
Other Names:
  • andard Urotherapy Combined with Solifenacin Drug Treatment
Experimental: Multimodal strategy
A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3
Behavioral: 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.
Drug: 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
Other Names:
  • Standard Urotherapy Combined with Vitamin D supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Target Achievement Rate at 12 Weeks
Time Frame: week 12
Percentage of participants who achieve their pre-defined personalized clinical goal set at Week 0.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weekly Urinary Incontinence (UI) Frequency
Time Frame: Baseline, 6 weeks, 12 weeks.
Change from baseline in the number of urinary incontinence episodes per week. Data is collected via a parent-reported voiding diary.
Baseline, 6 weeks, 12 weeks.
Change in Pediatric Incontinence Questionnaire (PIN-Q) Score
Time Frame: Baseline, 12 weeks.
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.
Baseline, 12 weeks.
Change in Pediatric Lower Urinary Tract Symptom (PLUTS) Score
Time Frame: Baseline, 6 weeks, 12 weeks.
Evaluation of the severity of lower urinary tract symptoms using the validated PLUTS scale. It assesses frequency, urgency, and other voiding symptoms.
Baseline, 6 weeks, 12 weeks.
Health Economics: Total Household Burden Cost
Time Frame: 12 weeks
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.
12 weeks
Change in Urinary Myelin Basic Protein (uMBP)/Creatinine Ratio
Time Frame: Baseline, 12 weeks.
To evaluate structural neural repair of the bladder-related nerves. Concentrations are normalized by urinary creatinine.
Baseline, 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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