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JU INSIGHT Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children
By: Hongsong Chen, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China; Zhicheng Zhang, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China; Shengde Wu, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China; Deying Zhang, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China; Xiaoni Zhong, MPH, School of Public Health and Management, Chongqing Medical University, PR China; Xing Liu, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China; Guanghui Wei, MD, Children’s Hospital of Chongqing Medical University, 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, Chongqing Key Laboratory of Pediatrics, PR China, Chongqing Key Laboratory of Children Urogenital Development and Tissue Engineering, PR China, Chongqing Medical University, PR China | Posted on: 19 Jan 2024
Chen H, Zhang Z, Wu S, et al. Efficacy and safety of high-dose vitamin D supplementation vs solifenacin or standard urotherapy for overactive bladder dry in children: a randomized clinical trial. J Urol. 2024;211(1):26-36.
Study Need and Importance
Managing pediatric overactive bladder (OAB) with pharmacological interventions poses several challenges, including a paucity of robust safety data and compromised persistence and adherence arising from medication-related side effects. Recent research suggests a potential link between insufficient vitamin D levels and OAB, yet the uncertainty persists regarding whether vitamin D supplementation (VDS) can improve OAB symptoms. Leveraging the established tolerance of high-dose VDS in children, this study evaluated the efficacy and safety of integrating this high-dose VDS strategy with standard urotherapy (SU) for the management of pediatric OAB-dry.
What We Found
We randomly assigned 303 children with OAB-dry to 1 of 3 interventions: VDS + SU group, solifenacin + SU group, or SU alone group. High-dose VDS + SU resulted in superior outcomes for voiding frequency, urgency scores (mean and max), quality of life scores, and pediatric lower urinary tract symptom scores compared to solifenacin + SU or SU alone (Table). VDS + SU exhibited good tolerability and outperformed solifenacin + SU. While solifenacin + SU effectively reduced voiding frequency compared to SU alone, it did not enhance the treatment satisfaction.
Table. Changes in Voiding Frequency and Other Urinary Symptoms
| Change in | Median (quartiles) | Between-group comparison (median difference [95% CI]; P value)a | ||||
|---|---|---|---|---|---|---|
| VDS + SU group | SOL + SU group | SU group | VDS + SU group vs SOL + SU group |
VDS + SU group vs SU group |
SOL + SU group vs SU group |
|
| Voiding frequency (voids/d) | 7.0 (5.0-9.0) | 4.0 (3.0-6.0) | 3.0 (1.1-5.0) | 3.0 (2.0-3.5); < .001 | 4.0 (3.0-5.0); < .001 | 1.0 (1.0-2.0); .002 |
| Urgency score (mean) | 1.1 (0.7-1.6) | 0.6 (0.3-1.0) | 0.5 (0.1-0.9) | 0.5 (0.4-0.7); < .001 | 0.7 (0.5-0.8); < .001 | 0.1 (0-0.3); .45 |
| Urgency score (max) | 1.0 (1.0-2.0) | 1.0 (0-1.0) | 0 (0-1.0) | 0.8 (0.0-1.0); < .001 | 1.0 (0.6-1.0); < .001 | 0 (0-0); .76 |
| Mean nocturia frequency (voids/night) | 0.2 (−0.1-0.6) | 0.3 (0-0.5) | 0 (−0.3-0.4) | 0 (−0.2-0.1); > .99 | 0.2 (0.1-0.4); .002 | 0.3 (0.2-0.4); < .001 |
| Quality of life score | 2.0 (1.0-2.0) | 1.0 (0-1.6) | 1.0 (0-1.0) | 1.0 (1.0-1.0); < .001 | 1.0 (1.0-1.0); < .001 | 0 (0-0); > .99 |
| Pediatric lower urinary tract symptom score | 6.0 (4.0-7.0) | 3.0 (1.0-5.0) | 3.0 (1.0-4.0) | 3.0 (2.0-4.0); < .001 | 3.0 (2.0-4.0); < .001 | 0 (0-1.0); > .99 |
| Abbreviations: SOL, solifenacin; SU, standard urotherapy; VDS, vitamin D supplementation. aComparison of continuous variables across groups was performed using the Wilcoxon rank-sum test. Hodges-Lehmann location shift estimates and 95% CIs are presented for comparisons associated with differences in medians. The P values were adjusted after the Bonferroni correction, and a P value of less than .05 was considered to be statistically significant. |
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Limitations
This study did not employ a fully blinded strategy and did not establish a placebo group. The discontinuation of intervention by participants in the VDS + SU group has the potential to amplify the impact of high-dose VDS. Long-term effects of VDS + SU were not evaluated, and additional optimization of SU interventions is necessary. This single-center study requires validation through multicenter investigations.
Interpretation for Patient Care
Our work suggests that assessing serum vitamin D levels can furnish valuable insights for a comprehensive evaluation of pediatric OAB-dry. The combination of high-dose VDS and SU emerges as a more attractive approach than either solifenacin plus SU or SU alone for the management of these patients.
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