We conducted a systematic review to evaluate the efficacy and adverse effects of newer drugs used to treat lower urinary tract symptoms (LUTS). The drugs were either Food and Drug Administration (FDA) approved for benign prostatic hyperplasia (BPH) or not FDA approved for BPH but have been evaluated for treatment of BPH since 2008. We searched bibliographic databases through September 2017. We included randomized controlled trials (RCTs) lasting one month or longer published in English. Outcomes of interest were LUTS assessed by validated measures. Efficacy was interpreted using established thresholds indicating clinical significance that identified the minimal detectable difference. Twenty-three unique, generally short-term, RCTs evaluating over 9000 participants were identified. Alpha-blocker silodosin and phosphodiesterase type 5 inhibitor tadalafil were more effective than placebo in improving LUTS (moderate strength evidence) but these drugs had more adverse effects, including abnormal ejaculation (silodosin). Anticholinergics were only effective versus placebo when combined with an alpha-blocker. Evidence was generally low strength or insufficient for other drugs. Evidence was insufficient to assess long-term efficacy, prevention of symptom progression, need for surgical intervention, or long-term adverse effects. Longer trials are needed to assess the effect of these therapies on response rates using established minimal detectable difference thresholds, disease progression, and harms.
The aging male : the official journal of the International Society for the Study of the Aging Male. 2018 Feb 02 [Epub ahead of print]
Roderick MacDonald, Michelle Brasure, Philipp Dahm, Carin M Olson, Victoria A Nelson, Howard A Fink, Michael C Risk, Bruce Rwabasonga, Timothy J Wilt
a Center for Chronic Disease Outcomes Research , Minneapolis Veterans Affairs Healthcare System , Minneapolis , MN , USA., b Division of Health Policy and Management , University of Minnesota, School of Public Health , Minneapolis , MN , USA., d Geriatric Research Education and Clinical Center , Minneapolis Veterans Affairs Healthcare System , Minneapolis , MN , USA., c Department of Urology , University of Minnesota , Minneapolis , MN , USA.