Overactive BladderNCT06489951
Efficacy and Mechanism of High-Dose Vitamin D Supplementation in Pediatric OAB-Dry: A Randomized Clinical Trial Integrating Urinary Myelin Basic Protein as a Theranostic Biomarker
A study testing Solifenacin, vitamin D and Standard behavioral therapy in people with Overactive Bladder and Pediatric Disorder, run by Xing Liu at 1 site in China.
Trial summary
The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Overactive Bladder, Pediatric Disorder
- What is being tested?
- Solifenacin, vitamin D and Standard behavioral therapy
- 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
- 28 Dec 2024to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 years who were admitted to the Department of Urology, Children's Hospital Affiliated to Chongqing Medical University and diagnosed with dry OAB.
- The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
- The child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent.
Who cannot join
- Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
- complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
- Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
- History of gastrointestinal surgery and urinary system surgery;
- Dry stool, long-term constipation;
- are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;
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- Previous history of hypercalcemia, hyperphosphatemia with renal rickets;
- History of unexplained hematuria and urinary tract infection in the past 1 year;
- Have a history of allergy or allergic reaction to vitamin D preparations;
- Participating in another clinical study at the time of visit or during the follow-up of another clinical study;
- Those who did not want to participate in the study or had poor follow-up compliance
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.
- Conditions
- Overactive Bladder, Pediatric Disorder
- Being tested
- Solifenacin, vitamin D, Standard behavioral therapy
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
The outpatient physician prescribed Solinaxine (up to 0.5mg daily) to the participant orally
vitamin DDietary supplement
The outpatient physician prescribed vitamin d drops (2400iu daily) for the participants, which were taken orally by the participants
Standard behavioral therapyBehavioural
Participants will receive an initial behavioral therapy session at enrollment and a second behavioral therapy session six weeks later. Education including information about dry OAB, lifestyle adjustments, bladder and pelvic floor training, bowel management, and how to use a bladder diary to record urination
| Study group | Role | What they receive |
|---|---|---|
| Standard Behavioral Therapy Combined with Solifenacin Drug Treatment | Experimental | Solinasine succinate 5mg once daily with a maximum dose of 10mg/day. Standard Behavioral Therapy Receives: Drug: Solifenacin; Behavioral: Standard behavioral therapy |
| Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation | Experimental | Oral vitamin D drops, 2400iu/d, continued for 6 weeks after follow-up. Standard Behavioral Therapy Receives: Dietary Supplement: vitamin D; Behavioral: Standard behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily urination frequency
To explore whether standard behavioral therapy combined with short-term high dose vitamin D (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving the daily frequency of urination in children with dry OAB.
Measured: week 1, week6，week 12
Secondary outcomes (2)
Change in the mean urgency score
To explore whether standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving mean urinal urgency scores in children with dry OAB.
Measured: week 1, week6，week 12
Change quality of life score
Quality of life scores are assessed on a scale of 0 to 3, where 0 indicates no impact on family, social or academic life; A score of 1 represents occasional effects; A score of 2 is a significant impact. A score of 3 indicates a serious impact on family, social or school life
Measured: week 1, week6，week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start28 Dec 2024
- Primary completion30 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xing Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital, Shanghai Children's Hospital, Children's Hospital of Soochow University, Guizhou Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xing Liu, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489951
- Sponsor's protocol ID
- 202453
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of High-Dose Vitamin D Supplementation in Pediatric OAB-Dry: A Randomized Clinical Trial Integrating Urinary Myelin Basic Protein as a Theranostic Biomarker
- ClinicalTrials.gov ID
- NCT06489951
- Acronym / sponsor ID
- 202453
- Conditions
- Overactive Bladder, Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Xing LiuUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital, Shanghai Children's Hospital, Children's Hospital of Soochow University, Guizhou Provincial People's Hospital
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 8 Jul 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 aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Behavioral Therapy Combined with Solifenacin Drug Treatment | Experimental | Drug: Solifenacin, Behavioral: Standard behavioral therapySolinasine succinate 5mg once daily with a maximum dose of 10mg/day. Standard Behavioral Therapy |
| Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation | Experimental | Dietary Supplement: vitamin D, Behavioral: Standard behavioral therapyOral vitamin D drops, 2400iu/d, continued for 6 weeks after follow-up. Standard Behavioral Therapy |
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 5 years who were admitted to the Department of Urology, Children's Hospital Affiliated to Chongqing Medical University and diagnosed with dry OAB.
- The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
- The child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent.
Key exclusion criteria (11 listed)
- Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
- complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
- Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
- History of gastrointestinal surgery and urinary system surgery;
- Dry stool, 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 |
|---|---|---|
| SolifenacinThe outpatient physician prescribed Solinaxine (up to 0.5mg daily) to the participant orally | Drug | Standard Behavioral Therapy Combined with Solifenacin Drug Treatment |
| vitamin DThe outpatient physician prescribed vitamin d drops (2400iu daily) for the participants, which were taken orally by the participants | Dietary supplement | Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation |
| Standard behavioral therapyParticipants will receive an initial behavioral therapy session at enrollment and a second behavioral therapy session six weeks later. Education including information about dry OAB, lifestyle adjustments, bladder and pelvic floor training, bowel management, and how to use a bladder diary to record urination | Behavioural | Standard Behavioral Therapy Combined with Solifenacin Drug Treatment, Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation |
Primary outcome
Change in daily urination frequency
Time frame: week 1, week6，week 12
To explore whether standard behavioral therapy combined with short-term high dose vitamin D (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving the daily frequency of urination in children with dry OAB.
2 secondary outcomes
Change in the mean urgency score
Time frame: week 1, week6，week 12
Change quality of life score
Time frame: week 1, week6，week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin, vitamin D and Standard behavioral therapy in people with Overactive Bladder and Pediatric Disorder, run by Xing Liu 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily urination frequency (time frame: week 1, week6，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 25 Nov 2025.