Session: MP45: Sexual Function/Dysfunction: Evaluation I
MP45-08: A systematic review and meta-analysis of the effect of mirabegron on the sexual health of patients with overactive bladder (OAB) and sexual dysfunction.
Introduction: Published data support an effect of mirabegron on the sexual function of OAB patients further to its well-known effect on the bladder. This effect may be via activation of ß3-adrenergic receptors in the corpus cavernosum tissue, causing vasodilatation independently of the NO-cGMP pathway. Other mechanisms involve a protective effect of mirabegron on pelvic endothelial dysfunction and induced vasorelaxation in both sexes’ genitalia. We systematically reviewed the literature concerning the effect of mirabegron on sexual dysfunction (SD) in both men and women. Methods: A systematic search was performed in Embase, Medline, Cochrane and Clinical Trial databases up to September 2022. We included observational and comparative studies with primary outcome the post-treatment changes of sexual function in men or women with OAB and SD. We followed the PRISMA guidelines and Cochrane methodology. Risk of bias and confounding assessments were performed. The magnitude effect was expressed as Standard Mean Difference (SMD). Results: Of 28 publications and conference abstracts selected for full-text screening, only six trials involving 259 patients (187 women and 72 men) met the inclusion criteria. None was randomized. The primary endpoint in women’s trials was the post-treatment changes in total FSFI (Female Sexual Function Index) score at 12 weeks. Meta-analysis showed a large-size treatment effect, with total FSFI score improving significantly from baseline [SMD]: -0.99(95%CI:-1.43,-0.54,p < 0.001)(figure). Men’s trials assessed the post-treatment changes in IIEF-5 (International Index of Erectile Function) at 12 weeks. Meta-analysis showed a small-size but significant treatment effect [SMD]:-0.38(95%CI:-0.74, -0.02,p=0.04). A phase II trial reported significant improvements in Sexual Health Inventory for Men scores at weeks 4 and 8 (p=0.0003) but not week 12. Conclusions: Current data support a significant beneficial effect of mirabegron in women suffering from SD and OAB and a smaller effect on the erectile function of men with OAB. The poor quality of included studies and the lack of randomized trials minimizes the value of these results. SOURCE OF Funding: None
