Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: p
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ORIGINAL ARTICLE
Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial Robert Snijder 1 & Brigitte Bosman 1 & Otto Stroosma 1 & Marja Agema 1 Received: 22 August 2019 / Revised: 4 March 2020 / Accepted: 16 March 2020 # The Author(s) 2020
Abstract This post hoc Poisson regression analysis investigated the relationship between mean volume voided and incontinence episodes/ 24 h after fixed frequency adjustment in children with overactive bladder from the LION study, a phase 3, double-blind, randomised, placebo-controlled, sequential, dose-titration solifenacin trial. Patients were aged 5–< 12 years with ≥ 4 episodes of daytime incontinence during a 7-day pre-baseline diary period. The dependent variable was the mean number of incontinence episodes/24 h at the end of study. Explanatory variables included treatment, mean number of incontinence episodes/24 h at baseline, and change from baseline to end of study in mean volume voided. Statistical significance and goodness of fit were analysed using the Pearson’s chi-square test. A negative estimate was found between the dependent variable ‘incontinence’ and both mean volume voided and daytime maximum volume voided/micturition (an increase in mean volume voided or daytime maximum volume voided/micturition would lead to a reduction in incontinence; P = 0.0014 and P = 0.0317, respectively). The model was a good fit to the data in both analyses with a Pearson’s chi-square goodness-of-fit criteria of 0.8. Conclusion: Increase in mean volume voided was significantly correlated to reduction in incontinence episodes/24 h in children with overactive bladder treated with solifenacin. This study is registered at ClinicalTrials.gov: NCT01565707. What is known: • Mean volume voided per micturition is used as an indicator of treatment efficacy, with increases noted as number of incontinence episodes (and micturition frequency) decrease. • The relationship between mean volume voided and incontinence episodes is not clearly understood. What is new: • Increase in mean volume voided significantly correlated to reduction in incontinence in solifenacin-treated children with overactive bladder (Poisson regression model analysis). • Compared with placebo, solifenacin-treated children had a lower predicted number of incontinence episodes/24 h.
Keywords Mean volume voided . Incontinence . Overactive bladder . Children . Solifenacin
Communicated by Mario Bianchetti * Robert Snijder [email protected] Brigitte Bosman [email protected]
Abbreviations DMaxVV Daytime maximum volume voided/micturition EoS End of study EoT End of treatment MVV Mean volume voided OAB Overactive bladder SD Standard deviation
Otto Stroosma [email protected] Marja Agema [email protected] 1
Astellas Pharma Europe B.V., Leiden, Netherlands
Introduction Overactive bladder (OAB) syndrome is defined by the International Children’s Continence Society as urinary
Eur J Pediatr
urgenc
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