The safety and efficacy of botulinum toxin-A in the management of bladder oversensitivity: A randomised double blind placebo controlled trial

Christopher Dowson (1) , Arun Sahai (2) , Jane Watkins (2) , Prokar Dasgupta (2) , Shamim Khan (2)

1 Urology
2 Urology

Objective To assess the safety and efficacy of botulinum toxin-A (botn-A) in the management of patients with Bladder oversensitivity (BO). Patients and Methods Twenty three consecutive patients with a diagnosis of BO refractory to anticholinergics were enrolled in this randomised, double blind, placebo controlled trial. Patients were randomly allocated to receive intra-detrusor injections of either botn-A (100U Botox®) or saline (placebo) via a flexible cystoscopic approach. The study was designed to have a 90% power to detect a change in the maximum cystometric capacity (MCC) of 30%. It was calculated that a total cohort of 58 patients would be required. Urodynamic assessment (UDS), voiding diaries (VD) and quality of life (QoL) were assessed at baseline and at 4 and 12 weeks following intervention. Results An interim analysis was performed and the trial halted after recruitment of 23 patients due to poorly perceived patient benefit. Data were analysed for 21 patients (10 botn-A; 11 placebo). In the treatment arm there was a significant increase in MCC (mean rise 105ml; p=0.009). However storage symptoms remained statistically unchanged following botn-A. Three patients in the treatment arm were required to perform clean intermittent self catheterisation with no clinical improvement. The limitations of this trial include the small samples size and the unplanned interim analysis. Conclusions: This is the first randomised, double blind, placebo controlled trial examining the effects of botn-A exclusively in patients with BO. A significant increase in MCC was observed but this did not translate to clinical benefit with no change observed in the symptoms and quality of life for the majority of patients.

Mots clés: Medicine

Christopher Dowson, Arun Sahai, Jane Watkins, Prokar Dasgupta, Shamim Khan. The safety and efficacy of botulinum toxin-A in the management of bladder oversensitivity: A randomised double blind placebo controlled trial. International Journal of Clinical Practice, 2011, 65 (6), pp.698. ⟨10.1111/j.1742-1241.2011.02663.x⟩. ⟨hal-00640463⟩