No. 353-Treatments for Overactive Bladder: Focus on Pharmacotherapy - An Addendum

ObjectiveThis technical update addendum reviews success rates and comparative evidence of the anticholinergic fesoterodine, as well as mechanism of action, safety profile, success rates, and comparative evidence of the β3 agonist mirabegron in the treatment of non-neurogenic overactive bladder syndrome (OAB). This adds to OAB pharmacotherapy recommendations initially published in 2012.Intended UsersResidents and other trainees, primary care practitioners, gynaecologists, urologists, urogynaecologists, and other health care providers who assess, counsel, and treat women with OAB.Target PopulationAdult women with symptomatic OAB.OptionsThis addition relates to fesoterodine, mirabegron, and anticholinergic-β3 agonist combination pharmacotherapy.OutcomesThe outcomes of interest are clinical efficacy of fesoterodine compared with no treatment or other OAB therapies; mechanism of action and safety profile of mirabegron, clinical efficacy of mirabegron compared to no treatment or other OAB therapies; clinical efficacy of anticholinergic-β3 agonist combination pharmacotherapy for OAB.EvidencePubMed, Medline, and the Cochrane Database were searched using the key words “fesoterodine” and “mirabegron.” Results were restricted to English or French and human clinical and pharmacological research. Animal research and clinical studies including only male participants were excluded. Articles were included until the end of December 2016. Grey literature was not searched. Clinical practice guidelines, guidelines of specialty societies, and systematic reviews were included. RCTs and observational studies were included when evidence for the outcome of interest or in the target population was not available from systematic reviews. New studies not yet included in systematic reviews were also included. References of included articles were also searched to ensure comprehensive inclusion of relevant literature.ValuesThe content and recommendations were drafted and agreed upon by the principal author, as well as members of the Urogynaecology Committee. The Board of the SOGC approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology framework. The Summary of Findings is available upon request.Benefits, Harms, and/or CostsIt is expected that this technical update will benefit patients with OAB by providing physicians and other interested health care providers with additional options for and knowledge of safe and effective OAB pharmacotherapy. The benefits clearly outweigh the potential harms or costs of implementation of this technical update, although there are no direct harms or costs identified.Updates“Evidence will be reviewed 5 years after publication to decide whether all or part of the document should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.”SponsorsNot applicable.Recommendations1.Fesoterodine is recommended as a treatment for overactive bladder (Strong, High).2.Dose escalation of fesoterodine is recommended for improved clinical efficacy, as it is associated with significant subjective and objective clinical improvement, both short and long term (Strong, High).3.Fesoterodine is recommended as an anticholinergic of choice for overactive bladder symptoms in elderly and frail elderly (Strong, High).4.Fesoterodine is recommended for overactive bladder symptoms in patients with pre-existing cardiac concerns or cognitive dysfunction (Strong, Moderate).5.Fesoterodine is recommended for nocturnal overactive bladder symptoms to improve sleep quality (Conditional, High).6.Mirabegron is recommended as a treatment for overactive bladder (Conditional, High).7.Mirabegron is recommended for overactive bladder symptoms in patients with intolerable side effects or suboptimal response on anticholinergic therapy (Strong, Moderate).8.Mirabegron may be used in combination with solifenacin 5 mg for overactive bladder symptoms as an alternative to solifenacin 10 mg to decrease anticholinergic side effects of the higher dose solifenacin (Conditional, High).