Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children

Study Overview
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Brief Summary
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This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.

Detailed Description
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Overactive bladder(OAB), characterized as urinary urgency accompanied in many instances by frequency and sometimes nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other documented pathology, is a common clinical entity in pediatric urology. The majority of patients with OAB do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia, which has been termed OAB dry. Currently, standard urotherapy is proposed as the first-line therapeutic options and adjunctive anticholinergics are usually used when urotherapy alone failed. Behavioral therapy often fail to achieve satisfied symptom control as children's poor compliance. In addition,adverse side effects such as dry mouth, constipation, gastro-oesophageal reflux result in early pharmacologic treatment discontinuation. It was informed that patients with OAB are more likely to suffer from vitamin D deficiency. The aim of the study is to determine the effect of vitamin D supplementation as an adjunctive therapy to behavioral therapy in the treatment of OAB dry. Eligible patients aged 5-18 years with a diagnosis of OAB dry will be randomly assigned into three groups to receive high dose vitamin D supplementation (combined with standard urotherapy ) , solifenacin (combined with standard urotherapy ) or standard urotherapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptoms severity will be assessed at baseline and followup. All the other sociodemographic data will be also assessed. The study will give more information on the application of vitamin D supplementation in the management of OAB dry.

Official Title
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Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]
* Drug: Vitamin D3
* Behavioral: Standard urotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children older than 5 years of age with a diagnosis of OAB dry (do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia) seen at the outpatient urology clinics (diagnosis follows the latest International Children's Continence Society recommendations). Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result. Written informed consent was obtained from participants and their parents. - Exclusion Criteria: Those with a comorbidity of other urological abnormalities or serious diseases (e.g. hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumours, urinary stones, bladder and urethral injuries, etc.). Those with a comorbidity of neurological disorders (e.g. epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) . Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders. Those with a history of gastrointestinal surgery and urinary tract surgery. Those with chronic constipation. Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs. Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets. Those have a history of haematuria and urinary tract infection within the last 1 year. Those have a history of allergy or allergic disease to vitamin D preparations. Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies. Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters. Those unwilling to participate in this study. -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The 3 groups will be treated at the same time
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose vitamin D supplementation (combined with standard urotherapy)<br>These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks | Drug: Vitamin D3<br>* These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.<br>* Other names: standard urotherapy;|
| Active Comparator: Solifenacin succinate group (combined with standard urotherapy)<br>These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks | Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]<br>* These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.<br>* Other names: standard urotherapy;|
| Active Comparator: standard urotherapy group<br>These patients will receive behavioral therapy alone for 8 weeks. | Behavioral: Standard urotherapy<br>* These patients will receive standard urotherapyfor 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in voiding frequency | Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean urgency score | Change in mean urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks | 8 weeks | 
| Change in max urgency score | Change in max urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks | 8 weeks | 
| Change in pediatric lower urinary tract symptom score | Change in pediatric lower urinary tract symptom score from baseline to the followup， score ranged from 0 to 21 and higher scores indicated a more frequent and severe occurrence of lower urinary tract symptoms. | 8 weeks | 
| Change in quality of life score | The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life. | 8 weeks | 
| Change in mean nocturia frequency, episodes/night | Change in mean nocturia frequency from baseline to the followup | 8 weeks | 
| Change in vitamin D level | Change in vitamin D level from baseline to the followup | 8 weeks | 
| Global perception of improvement | Global perception of improvement (much better; better; about the same; worse) | 8 weeks | 
| Wish to receive another form of treatment? | Wish to receive another form of treatment? (YES; No) | 8 weeks |