PD22-09 MANAGEMENT OF MALE LOWER URINARY TRACT SYMPTOMS IN A SIMULATED OVER-THE-COUNTER SETTING: AN EXPLORATORY, ACTUAL-USE STUDY OF AN ALPHA BLOCKER

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical & Non-surgical Therapy1 Apr 2016PD22-09 MANAGEMENT OF MALE LOWER URINARY TRACT SYMPTOMS IN A SIMULATED OVER-THE-COUNTER SETTING: AN EXPLORATORY, ACTUAL-USE STUDY OF AN ALPHA BLOCKER Claus G. Roehrborn, Franklin C. Lowe, Marc Gittelman, Jan M. Wruck, and Anna E. Verbeek Claus G. RoehrbornClaus G. Roehrborn More articles by this author , Franklin C. LoweFranklin C. Lowe More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , Jan M. WruckJan M. Wruck More articles by this author , and Anna E. VerbeekAnna E. Verbeek More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1502AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men and considerably affect quality of life. This study evaluated characteristics of men interested in an over-the-counter (OTC) option to self-manage their LUTS and their ability to use the product responsibly in an unsupervised setting. METHODS An 8-week, open-label, uncontrolled, exploratory, OTC-simulated study of tamsulosin hydrochloride 0.4 mg capsules in men recruited through an advertisement on bothersome urinary symptoms. Subjects’ ability to responsibly select and use the study drug as directed by the study Drug Facts Label (DFL), without physician intervention was assessed. The DFL had the product purpose, directions for use, and instructions on when to stop use or ask a doctor or a pharmacist. RESULTS Of the 689 subjects who entered the study, 679 were evaluable, of whom, 143 currently using alpha-blockers were excluded from purchasing the study drug. Overall, 369 subjects purchased the study drug; 321 took = 1 dose and had = 1 follow-up interview. At baseline, most subjects reported visiting healthcare providers (HCPs) = 1 times/year, had moderate to severe LUTS for = 3 years, and had discussed these symptoms with HCPs (Table). Baseline LUTS were similar among subjects entering the study and those purchasing the study drug. During the study, 274 (85.4%) men were compliant with the DFL instructions and directions. Of the 351 subjects who took = 1 dose, 139 (39.6%) reported = 1 adverse event (AE), of which 65 (18.5%) were deemed drug related. Most common drug-related AEs were dizziness 11 (3.1%), ejaculation disorder 6 (1.7%), and semen volume decreased 6 (1.7%). Most AEs were mild, and 1 serious AE was deemed study drug related. Overall, there were no unexpected AEs and most men reported improvement in their LUTS with study drug. CONCLUSIONS Men with LUTS attributed to BPH visit HCPs regularly, yet, may not be prescribed medication. According to this study, men interested in an OTC alpha-blocker to self-manage their LUTS are not at an increased risk of unexpected AEs in an unsupervised setting. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e464-e465 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Claus G. Roehrborn More articles by this author Franklin C. Lowe More articles by this author Marc Gittelman More articles by this author Jan M. Wruck More articles by this author Anna E. Verbeek More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...