What is the role of solifenacin (Vesicare) in the treatment of overactive bladder (OAB) in children?

Updated: Apr 01, 2019
  • Author: Pamela I Ellsworth, MD; Chief Editor: Edward David Kim, MD, FACS  more...
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Solifenacin (Vesicare), an agent commonly used in adults, was studied in small series of children. A prospective open-label study evaluated its efficacy in children with OAB refractory to oxybutynin or tolterodine. An adjusted-dose regimen of 1.25-10 mg of solifenacin was used in 45 children with OAB and 27 children with neurogenic bladder. Mean urodynamic capacity improved, uninhibited contractions decreased, and continence improved in all patients. Fifteen patients had mild adverse effects, 3 had moderate adverse effects, and 4 withdrew because of intolerable adverse effects. [35]

A long-term extension of that study, with recruitment of additional patients, was conducted in children with neurogenic (n=53) and non-neurogenic (n=191) OAB in whom intensive optimized oxybutynin or tolterodine treatment and behavioral therapies produced only partial clinical and urodynamic responses or significant side effects. Minimum follow-up was 5 months and mean duration of treatment was 21 months. [36]

Urodynamic capacity improved from 145+/- 76 mL to 339 +/- 152 mL and the amplitude of uninhibited bladder contractions decreased from 66 +/- 26 to 20 +/- 20 cm H2O (P < 0.0001). The overall success rate was 94% for non-neurogenic OAB and 79% for neurogenic OAB; 23 patients discontinued treatment for unsatisfactory clinical response or bothersome side effects. No side effects were reported by 175 patients, mild by 46, moderate by 9, and 14 withdrew due to side effects. Ten patients developed post void residuals of 20 mL or greater. [36]  

Hoebeke et al reviewed the charts of children treated with 5 mg of solifenacin for resistant OAB from August 2005 to August 2008 to evaluate the effect on incontinence. One hundred thirty-nine children received solifenacin. Adverse effects were reported in 6.5%. A 25% increase in mean voided volume was noted, and 84 (85%) were considered to be responders, with 45 completely dry and 39 with fewer nocturnal enuresis episodes or diurnal incontinence symptoms. In 25, the outcome was unchanged or worse (nonresponder). [37]

In an open-label study of 34 children with newly diagnosed OAB, treatment with a 5-mg fixed dose of solifenacin resulted in a decrease of the mean voiding frequency during daytime from 9.4 ± 3.0 to 6.5 ± 2.3 times after 12 weeks (P < 0.001). The urgency and urgency urinary incontinence significantly improved and complete resolution of urgency occurred in 38.9% of patients. Drug-induced adverse effects were reported in 7 patients (20.6%) but were mild and included dry mouth, constipation, fatigue and sleepiness. [38]

A phase III randomized double-blind, placebo-controlled clinical trial (n=189) evaluated the efficacy and safety of once-daily oral solifenacin suspension in overactive bladder patients age 5 to 11 years (children) and age 12 to 18 years (adolescents). After a 4-week urotherapy run-in, patients were randomized to 12 weeks of solifenacin or placebo along with urotherapy. Solifenacin was started at a dose of 5 mg and titrated to an optimum dose at 3-week intervals over 9 weeks, resulting in at least 3 weeks at optimum dosing before the end of treatment (EoT). [39]

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