Botulinum toxin A versus percutaneous tibial nerve stimulation in idiopathic overactive bladder: a randomized trial

Abstract

The uprising number of people suffering from overactive bladder, has made evident the need of new treatments to tackle the condition in patients refractory to oral therapies. The development of third line therapies for overactive bladder, has given a lot of patients an opportunity to gain quality of life. However, these treatments can associate severe side effects, which compels us to be cautious with its prescription. This study compares the efficacy of intradetrusor Botox ® injections and percutaneous tibial nerve stimulation measured in quality of life. In addition, an analysis of the security, convenience and cost-effective is included. We designed multicenter clinical trial, where sequential sampling will be used to enroll a total of 234 individuals. By randomization, we will allocate the subjects in a group for botulinum toxin or a group for tibial nerve stimulation. The collaboration of seven hospitals will be required to perform this evaluation. Our principal endpoint will be the punctuation in a disease-specific questionnaire after 12 months. The follow up will be conducted at 3, 6, 9 and 12 months with urodynamic measures, symptom reports and quality of life questionnaire