By Crina Frincu-Mallos, PhD
WASHINGTON, DC -- October 22, 2009 -- Solifenacin significantly improves urodynamic capacity and continence in children with overactive bladder, researchers reported here at the 2009 American Academy of Pediatrics (AAP) National Conference & Exhibition.
"In the presence of overactive bladder refractory to oxybutynin or tolterodine, solifenacin was proven to be an alternative [therapy] to improve symptoms in the paediatric population," said Stéphane Bolduc, MD, Université Laval, Laval, Québec.
Oxybutynin has been effective in treating overactive bladder in children, said Dr. Bolduc, but there are safety concerns regarding its use in this patient population. Tolterodine has proven to be effective in treating the symptoms of overactive bladder, with fewer adverse events, he added.
"Newer agents, such as solifenacin, could be an alternative but their use in children has never been reported," he said during a presentation on October 18.
The prospective, open-label trial assessed the optimal dose, as well as the efficacy and safety of solifenacin in children with overactive bladder who were refractory to either oxybutynin or tolterodine. Researchers selected efficacy towards continence to be the primary study endpoint, with tolerability and safety as secondary endpoints.
A total of 66 children (37 girls, 29 boys) were enrolled in this study. At the time the study was initiated, the patients had a mean age of 8.8 years. They were administered adjusted-dose regimens of solifenacin, between 1.25 and 10 mg. The duration of the treatment lasted on average 12 months.
Of the children, 26 with neurogenic bladder (10 clean intermittent catheterisation) and 40 with overactive bladder completed a minimum of 3-months' follow-up, said Dr. Bolduc.
"The follow-up consisted of voiding diaries, postvoid residuals, and urine cultures every 3 months, and ultrasound and ultrasound Doppler sonography every 6 months," he explained.
In addition to collecting blood samples and electrocardiograms (ECGs) to monitor potential toxicity, the investigators also involved the patients' families in the follow-up. They reported not only changes in continence and adverse events, but also compliance with taking the solifenacin tablets, as well as changes in behaviour and quality of life.
The investigators reported an improvement in the urodynamic capacity from 151 +- 66 mL to 325 +- 135 mL. Solifenacin also helped decrease uninhibited bladder contractions in the study cohort, from 71 +- 29 to 22 +- 18 cm H2O.
Furthermore, continence improved in all patients on study: 24 patients remained dry, 36 patients experienced a significant improvement, and 6 showed a moderate improvement.
In terms of toxicity, there were 14 mild adverse events and 2 moderate adverse events. Also, 2 patients chose to withdraw from the study due to toxicity. Despite the fact that their blood tests and ECGs remained normal, 4 patients developed significant postvoid residuals (>20%).
"Tolerability was acceptable and the adjusted-dose regimen appeared safe," concluded Dr. Bolduc.
[Presentation title: Prospective Open-Label Study of Solifenacin for Overactive Bladder in Children. Abstract 6547]
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