Efficacy and Safety of High-Dose Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children: A Randomized Clinical Trial

No AccessJournal of UrologyOriginal Research Articles1 Jan 2024Efficacy and Safety of High-Dose Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children: A Randomized Clinical TrialThis article is commented on by the following:Editorial CommentEditorial Comment Hongsong Chen, Zhicheng Zhang, Shengde Wu, Deying Zhang, Xiaoni Zhong, Xing Liu, and Guanghui Wei Hongsong ChenHongsong Chen Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author , Zhicheng ZhangZhicheng Zhang Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author , Shengde WuShengde Wu Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author , Deying ZhangDeying Zhang Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author , Xiaoni ZhongXiaoni Zhong Chongqing Medical University, Chongqing, PR China School of Public Health and Management, Chongqing Medical University, Chongqing, PR China More articles by this author , Xing LiuXing Liu *Corresponding Author: Xing Liu, MD, Department of Urology, Children’s Hospital of Chongqing Medical University, 136 Zhongshan Rd, Chongqing400014, PR China ( E-mail Address: [email protected] https://orcid.org/0000-0002-9249-1366 Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author , and Guanghui WeiGuanghui Wei Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003763AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We investigated the efficacy and safety of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing overactive bladder dry in children. Materials and Methods: A 3-arm, randomized clinical trial was performed at an academic center in China between January 2023 and June 2023. Eligible patients (n=303) were randomized to receive 8 weeks of high-dose VDS (vitamin D3 drops encapsulated as soft capsules, 2400 IU/d) plus SU (VDS + SU group; n=100), solifenacin (5-10 mg/d) plus SU (SOL + SU group; n=102), or SU alone (SU group; n=101). Reduction in voiding frequency was the primary outcome. Secondary outcomes encompassed improvement in urgency, nocturia, quality of life score, pediatric lower urinary tract symptom score, and participant satisfaction. Treatment-emergent adverse events were recorded within each group. Results: Participants had a median age of 82.0 months and their baseline mean vitamin D level was 22.64 ng/mL. The VDS + SU group showed greater improvements in voids/d than the SOL + SU group (median difference 3.0; 95% CI, 2.0 to 3.5; P < .001) and the SU group (median difference 4.0; 95% CI, 3.0 to 5.0; P < .001) after intervention. The VDS + SU group also showed the greatest improvement in quality of life and pediatric lower urinary tract symptom scores. Patient satisfaction was similar between the SOL + SU and SU groups. The VDS + SU group did not exhibit a heightened risk of treatment-emergent adverse events compared to the other groups. Conclusions: High-dose VDS plus SU was effective and well-tolerated in managing overactive bladder dry in children, suggesting its potential as a novel therapeutic option for this population. REFERENCES 1. . Overactive bladder in children. Nat Rev Urol. 2016; 13(9):520-532. Crossref, Medline, Google Scholar 2. How dry is “OAB-dry”? Perspectives from patients and physician experts. J Urol. 2012; 188(5):1811-1815. Link, Google Scholar 3. . 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Crossref, Medline, Google Scholar Support: This study was funded by the National Natural Science Foundation of China (Grant Number: 81970571) and the Program for Youth Innovation in Future Medicine at Chongqing Medical University (Grant Number: 3001112). The funder of the study had no role in study design, patient recruitment, data collection and analysis, interpretation of the data, or writing of the manuscript. Conflict of Interest Disclosures: The Authors have no relationships/conditions/circumstances that present a potential conflict of interest. Ethics Statement: This study received Institutional Review Board approval (IRB No. 2022515). All human subjects provided written informed consent with guarantees of confidentiality. In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: The first author (Hongsong Chen) and corresponding author (Xing Liu) had full access to all the data in the study and had final responsibility for the decision to submit for publication. Data Availability: Except for the patients’ privacy, some fields in data, the study protocol, statistical analysis plan, data dictionary, and deidentified results of these analyses are available for scientific researchers upon reasonable request through the corresponding author. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySiemens D and Wan J (2023) Editor's Choice: January 2024Journal of Urology, VOL. 211, NO. 1, (1-2), Online publication date: 1-Jan-2024.Chen H, Zhang Z, Wu S, Zhang D, Zhong X, Liu X and Wei G (2023) Reply By AuthorsJournal of Urology, VOL. 211, NO. 1, (36-36), Online publication date: 1-Jan-2024.Schlomer B (2023) Editorial CommentJournal of Urology, VOL. 211, NO. 1, (35-36), Online publication date: 1-Jan-2024.Franco I (2023) Editorial CommentJournal of Urology, VOL. 211, NO. 1, (35-35), Online publication date: 1-Jan-2024.Related articlesJournal of Urology10 Nov 2023Editorial CommentJournal of Urology10 Nov 2023Editorial Comment Volume 211Issue 1January 2024Page: 26-36Supplementary Materials Peer Review Report January 2024 JU PRR/JU-23-1035 PRR Patient Summary Open Patient Summary Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Keywordsoveractive bladderchildrenvitamin Drandomized controlled trialsafetyAcknowledgmentsWe thank Junjun Dong, MD, Xingyue He, MD, Yi Wei, MD, and Chun Wei, MD (Children’s Hospital of Chongqing Medical University), for serving as the medical monitors for this study. We thank Chong Wang, MD, Zihan Ye, MM, and Xiao Wang, MM (Children’s Hospital of Chongqing Medical University), for serving as study coordinators. We thank Yanxi Wang, MM (Children’s Hospital of Chongqing Medical University), for serving as the clinical data manager. We thank Bin Lin, MPH (School of Public Health and Management, Chongqing Medical University), and Zhenmin Liu, MD (Children’s Hospital of Chongqing Medical University), for developing the statistical plan. All of these persons provided uncompensated assistance. We thank all of the participating families for participating in this clinical trial.Metrics Author Information Hongsong Chen Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author Zhicheng Zhang Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author Shengde Wu Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author Deying Zhang Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author Xiaoni Zhong Chongqing Medical University, Chongqing, PR China School of Public Health and Management, Chongqing Medical University, Chongqing, PR China More articles by this author Xing Liu Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China *Corresponding Author: Xing Liu, MD, Department of Urology, Children’s Hospital of Chongqing Medical University, 136 Zhongshan Rd, Chongqing400014, PR China ( E-mail Address: [email protected] More articles by this author Guanghui Wei Department of Urology, Children’s Hospital of Chongqing Medical University, Chongqing, PR China Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, PR China National Clinical Research Center for Child Health and Disorders, Chongqing, PR China China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, PR China Children’s Hospital of Chongqing Medical University, Chongqing, PR China Chongqing Key Laboratory of Pediatrics, Chongqing, PR China Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, Chongqing, PR China Chongqing Medical University, Chongqing, PR China More articles by this author Expand All Support: This study was funded by the National Natural Science Foundation of China (Grant Number: 81970571) and the Program for Youth Innovation in Future Medicine at Chongqing Medical University (Grant Number: 3001112). The funder of the study had no role in study design, patient recruitment, data collection and analysis, interpretation of the data, or writing of the manuscript. Conflict of Interest Disclosures: The Authors have no relationships/conditions/circumstances that present a potential conflict of interest. Ethics Statement: This study received Institutional Review Board approval (IRB No. 2022515). All human subjects provided written informed consent with guarantees of confidentiality. In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: The first author (Hongsong Chen) and corresponding author (Xing Liu) had full access to all the data in the study and had final responsibility for the decision to submit for publication. Data Availability: Except for the patients’ privacy, some fields in data, the study protocol, statistical analysis plan, data dictionary, and deidentified results of these analyses are available for scientific researchers upon reasonable request through the corresponding author. Advertisement PDF downloadLoading ...