Long-term use of solifenacin in pediatric patients with overactive bladder: Extension of a prospective open-label study

Authors

  • Geneviève Nadeau CHU de Québec Université Laval
  • Annette Schröeder Division of Urology The Hospital for Sick Children
  • Katherine Moore CHU de Québec Université Laval
  • Lucie Genois CHU de Québec
  • Pascale Lamontagne IRDPQ
  • Micheline Hamel IRDPQ
  • Ève Pellerin CHU de Québec
  • Stéphane Bolduc CHU de Québec Université Laval

DOI:

https://doi.org/10.5489/cuaj.1356

Keywords:

Overactive detrusor, children, anticholinergic, oxybutinin, tolterodine, solifenacin

Abstract

Introduction: We evaluate the efficacy and safety of solifenacin to treat incontinence in children with non-neurogenic (DO) or neurogenic detrusor overactivity (NDO) refractory to oxybutininor tolterodine.

Methods: We updated and extended our previously published non-randomized uncontrolled study on open-label use of adjusted-dose regimens of solifenacin (1.25-10 mg) in children with refractory incontinence. The follow-up included voiding diaries, post-void residuals, urine cultures, ultrasounds and urodynamic studies. Clinical data were updated as of September 2012. Subjective improvement was assessed with the Patient Perception of Bladder Condition (PPBC) scale. The primary end point was efficacy toward continence and secondary end points were tolerability and safety.

Results: Overall, 244 patients (112 girls, 132 boys) were enrolled; 53 with NDO and 191 with DO. Minimal follow-up was 5 months, the mean duration of treatment was 21.0 months and the mean age at initiation was 9.2 years. Urodynamic capacity improved from 145 ± 76 mL to 339 ± 152 mL and the amplitude of uninhibited contractions decreased from 66 ± 26 to 20 ± 20 cmH2O (p < 0.0001). The overall success rate is 91%, and more specifically 94% for non-neurogenic and 79% for neurogenic, which is significantly different (p = 0.013). Twenty-three 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 their side effects. Ten patients developed post-void residuals of ≥20 mL.

Conclusion: Although higher in the non-neurogenic group, high subjective and objective success rates were maintained over a longer follow-up with an adjusted-dose regimen of solifenacin to treat pediatric NDO or DO refractory to oxybutynin or tolterodine. Moreover, we found acceptable tolerability and safety profiles.

 

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Author Biographies

Geneviève Nadeau, CHU de Québec Université Laval

Department of Surgery

Annette Schröeder, Division of Urology The Hospital for Sick Children

Department of surgery

Katherine Moore, CHU de Québec Université Laval

Department of surgery

Lucie Genois, CHU de Québec

RN

Pascale Lamontagne, IRDPQ

RN

Micheline Hamel, IRDPQ

RN

Stéphane Bolduc, CHU de Québec Université Laval

Department of surgery

Associate professor

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Published

2014-04-14

How to Cite

Nadeau, G., Schröeder, A., Moore, K., Genois, L., Lamontagne, P., Hamel, M., Pellerin, Ève, & Bolduc, S. (2014). Long-term use of solifenacin in pediatric patients with overactive bladder: Extension of a prospective open-label study. Canadian Urological Association Journal, 8(3-4), 118–23. https://doi.org/10.5489/cuaj.1356

Issue

Section

Original Research