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

Autor:	Chen H; 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., Zhang Z; 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., Wu S; 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., Zhang D; 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., Zhong X; Chongqing Medical University, Chongqing, PR China.; School of Public Health and Management, Chongqing Medical University, Chongqing, PR China., Liu X; 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., Wei G; 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.
Jazyk:	angličtina
Zdroj:	The Journal of urology [J Urol] 2024 Jan; Vol. 211 (1), pp. 26-36. Date of Electronic Publication: 2023 Oct 23.
DOI:	10.1097/JU.0000000000003763
Abstrakt:	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.
Databáze:	MEDLINE
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