Urinary Bladder, OveractiveNCT06201013
Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet
A study testing urotherapy, Solifenacin Succinate and Vitamin D3 in people with Urinary Bladder, Overactive and Overactive Bladder, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Urinary Bladder, Overactive, Overactive Bladder, Urinary Incontinence, Urge
- What is being tested?
- urotherapy, Solifenacin Succinate and Vitamin D3
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Li Qiu, Doctor, 86-23-63612114, dr.liux0217@163.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- urotherapy, Solifenacin Succinate, Vitamin D3
- Keywords
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Vitamin D
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urotherapyBehavioural
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 SuccinateDrug
Also called andard Urotherapy Combined with Solifenacin Drug Treatment
In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day
Vitamin D3Drug
Also called Standard Urotherapy Combined with Vitamin D supplementation
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 group | Role | What they receive |
|---|---|---|
| Standard-of-care | Active comparator | Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day Receives: Behavioral: urotherapy; Drug: Solifenacin Succinate |
| Multimodal strategy | Experimental | A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3 Receives: Behavioral: urotherapy; Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Target Achievement Rate at 12 Weeks
Percentage of participants who achieve their pre-defined personalized clinical goal set at Week 0.
Measured: week 12
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Apr 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Liu, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201013
- Sponsor's protocol ID
- 2023922
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06201013
- Acronym / sponsor ID
- 2023922
- Keywords
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Vitamin D
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | Active comparator | Behavioral: urotherapy, Drug: Solifenacin SuccinateStandard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day |
| Multimodal strategy | Experimental | Behavioral: urotherapy, Drug: Vitamin D3A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urotherapyParticipants 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. | Behavioural | Multimodal strategy, Standard-of-care |
| Solifenacin SuccinateAlso: andard Urotherapy Combined with Solifenacin Drug TreatmentIn addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day | Drug | Standard-of-care |
| Vitamin D3Also: Standard Urotherapy Combined with Vitamin D supplementationIn 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 | Drug | Multimodal strategy |
Primary outcome
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.
5 secondary outcomes
Change in Weekly Urinary Incontinence (UI) Frequency
Time frame: Baseline, 6 weeks, 12 weeks.
Change in Pediatric Incontinence Questionnaire (PIN-Q) Score
Time frame: Baseline, 12 weeks.
Change in Pediatric Lower Urinary Tract Symptom (PLUTS) Score
Time frame: Baseline, 6 weeks, 12 weeks.
Health Economics: Total Household Burden Cost
Time frame: 12 weeks
Change in Urinary Myelin Basic Protein (uMBP)/Creatinine Ratio
Time frame: Baseline, 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urotherapy, Solifenacin Succinate and Vitamin D3 in people with Urinary Bladder, Overactive and Overactive Bladder, run by Children's Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xing Liu (18725665020, CHS_1900@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Target Achievement Rate at 12 Weeks (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.