Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial

Abstract Background Solifenacin, an effective, well-tolerated treatment for adult overactive bladder (OAB) symptoms, has not been evaluated in placebo-controlled paediatric clinical trials. Objectives To evaluate the efficacy and safety of once-daily oral solifenacin suspension in OAB patients aged 5– Design, setting, and participants The study involved a 4-wk urotherapy run-in followed by 1:1 randomisation to 12-wk double-blind solifenacin or placebo treatment alongside urotherapy. Intervention Solifenacin paediatric equivalent doses (PEDs) of adult doses: 2.5mg, 5mg, 7.5mg, and 10mg. The starting dose was PED 5mg; all patients were titrated to an optimum dose at 3-wk intervals over 9 wk, resulting in ≥3 wk at the optimum dose before end of treatment (EoT). Outcome measurements and statistics Superiority of solifenacin versus placebo in change from baseline to EoT for mean volume voided/micturition (MVV, primary endpoint); daytime maximum volume voided/micturition (DMaxVV); incontinence episodes (mean/24h); mean number of incontinence-free days or nights/7 d; micturition frequency; and Micturition frequency adjusted for baseline total voided volume (VT B ) as an exploratory parameter). Efficacy parameters were analysed using analysis of covariance. Safety parameters (treatment-emergent adverse events, serious adverse events, laboratory variables, vital signs, electrocardiogram, postvoid residual volume) are summarised using descriptive statistics. Results and limitations In children, solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV (solifenacin-placebo difference 12.1ml, 95% confidence interval [CI] 0.2–24.0; p =0.046), DMaxVV (difference in adjusted mean change from baseline for solifenacin–placebo 31.9ml, 95% CI 4.3–59.5; p =0.024), VT B -adjusted micturition frequency ( p =0.028). Other endpoints were not significantly different. Solifenacin was well tolerated. For adolescents, it was not possible to draw firm efficacy conclusions because of the low numbers recruited. Conclusions Once-daily solifenacin oral suspension in children with OAB was superior to placebo for MVV (primary efficacy endpoint) and was well tolerated. Patient summary In this 12-wk study, a once-daily oral suspension of solifenacin in children aged 5– This study is registered at ClinicalTrials.gov as NCT01565707.