Clinical Trials Logo

Clinical Trial Summary

The purpose of this clinical trial is to investigate whether standard behavioral therapy combined with high-dose vitamin D (2400iu daily) is superior to standard behavioral therapy alone and standard behavioral therapy combined with solifenacin medication in improving frequency of incontinence and lower urinary tract symptom scores in children with wet OAB. Dedicated to understanding the current best treatment for wet OAB and to informing future clinical decisions and improving patient prognosis. The main questions it seeks to answer are - Question 1 To attempt to elucidate the relationship between vitamin D levels and their lower urinary tract symptoms. - Question 2 To examine the etiologic role of vitamin D in wet OAB in children. - Question 3 Compare the effectiveness and safety of interventions to elucidate the etiologic mechanisms and optimal intervention strategies for wet OAB in children. The researchers will compare (1) standard behavioral therapy with solifenacin (2) standard behavioral therapy with high-dose vitamin D (3) standard behavioral therapy alone to observe the clinical efficacy and safety of the three interventions for children with wet OAB.


Clinical Trial Description

[Study Objective]. Primary objective: to investigate whether standard behavioral therapy combined with high-dose vitamin D (2400iu per day) is superior to standard behavioral therapy alone and standard behavioral therapy combined with solifenacin medication in improving frequency of urinary incontinence and lower urinary tract symptom scores in children with wet OAB. Secondary objectives: 1. To investigate whether this standard behavioral therapy combined with oral solifenacin and vitamin D supplementation regimen is superior to the remaining two groups in the following secondary efficacy outcomes. - Number of urinations per day - number of nocturia - Quality of life - Serum vitamin D levels - Overall patient satisfaction with treatment 2. To examine whether any effect of vitamin D supplementation on the above outcomes is modified by baseline vitamin D levels, and baseline lower urinary tract symptom severity (secondary outcome, efficacy). 3. Explore whether the treatment regimen of standard behavioral therapy combined with oral solifenacin and vitamin D is safe and well tolerated (secondary outcome, safety). [Study Steps]. 1. Design of Randomization Methods: After completion of a comprehensive baseline assessment, eligible participants are randomized 1:1:1 into three distinct intervention groups. Statisticians independent of this clinical monitoring will generate a randomization table from the PROC PLAN process of the SAS program based on predetermined seed and block numbers. The generated randomization codes will be recorded sequentially in sealed envelopes entrusted to the custody of the residents not involved in the trial. 2. Procedure for inclusion of study subjects: participants will be selected among patients with confirmed wet OAB and serum vitamin D levels below 35 ng/ml in the urology department of our hospital. We will exclude patients with other organic diseases and poor compliance. The guardians of the children will obtain informed consent and sign a paper consent form before starting the intervention. 4.Clinical data collection: information on the demographic characteristics of the child at the initial visit, medical history, family history, history of maternal vitamin D supplementation during pregnancy, history of vitamin D supplementation in the child, laboratory findings (serum vitamin D, routine urinalysis), abdominal imaging findings, and a diary of voiding will be kept by the participant for 7 days to establish a baseline. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06201013
Study type Interventional
Source Children's Hospital of Chongqing Medical University
Contact Xing Liu
Phone 18725665020
Email wyx_blaze@163.com
Status Recruiting
Phase N/A
Start date September 3, 2023
Completion date October 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT00910845 - Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3