Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Solifenacin Succinate 5 MG Oral Tablet [Vesicare]; Vitamin D3; Standard urotherapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.; These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.; These patients will receive standard urotherapyfor 8 weeks.
Other intervention name(s): standard urotherapy; standard urotherapy
Intervention MeSH terms: Vitamin D; Cholecalciferol; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 3 groups will be treated at the same time
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment