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Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial
Donald Newgreen1, Brigitte Bosman1, Adriana Hollestein-Havelaar1
1Astellas Pharma Europe BV, Leiden, The Netherlands.
Insights
Solifenacin oral suspension effectively treated overactive bladder (OAB) in children, improving bladder volume and tolerability. This study provides crucial data for pediatric OAB management.
Area of Science:
- Pediatric Urology
- Pharmacology
- Clinical Trials
Background:
- Overactive bladder (OAB) affects children, but effective treatments require more evidence.
- Solifenacin is a known OAB treatment for adults, yet its pediatric use is understudied.
- Placebo-controlled trials are essential to validate pediatric OAB treatments.
Purpose of the Study:
- To assess the efficacy and safety of daily solifenacin suspension in children (5-12 years) and adolescents (12-18 years) with OAB.
- To establish optimal dosing and treatment duration for pediatric OAB patients.
- To compare solifenacin's effectiveness against a placebo in a pediatric population.
Main Methods:
- A 12-week, double-blind, randomized trial comparing solifenacin suspension to placebo, following a 4-week urotherapy run-in period.
- Patients received escalating doses of solifenacin (PEDs 2.5-10mg) titrated to an optimal dose over 9 weeks.
- Efficacy was measured by changes in mean volume voided/micturition (MVV) and other OAB symptoms; safety was monitored via adverse events and clinical assessments.
Main Results:
- Solifenacin demonstrated superiority over placebo in children, significantly improving MVV (primary endpoint) and daytime maximum voided volume.
- Pediatric patients experienced well-tolerated treatment with low incidence of dry mouth and constipation.
- Efficacy conclusions for adolescents were limited due to insufficient participant numbers.
Conclusions:
- Once-daily solifenacin oral suspension is an effective and well-tolerated treatment for children with overactive bladder.
- The study supports solifenacin's use as a viable therapeutic option for pediatric OAB.
- Further research may be needed to confirm efficacy in adolescent populations.
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-<12 yr (children) and 12-<18 yr (adolescents).
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 (VTB) 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), VTB-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-<12 yr with overactive bladder was superior to placebo in increasing mean volume voided/micturition, the primary efficacy variable in the study. Solifenacin was well tolerated, with a low incidence of dry mouth and constipation. This study is registered at ClinicalTrials.gov as NCT01565707.
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