PD59-04 A DOUBLE BLINDED, RANDOMIZED CONTROLLED TRIAL COMPARING TAMSULOSIN AND PLACEBO VERSUS TAMSULOSIN AND TADALAFIL IN MALE LOWER URINARY TRACT SYMPTOMS

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical & Non-surgical Therapy1 Apr 2018PD59-04 A DOUBLE BLINDED, RANDOMIZED CONTROLLED TRIAL COMPARING TAMSULOSIN AND PLACEBO VERSUS TAMSULOSIN AND TADALAFIL IN MALE LOWER URINARY TRACT SYMPTOMS Santhosh Nagasubramanian, Nirmal Thampi John, Belavendra Antonisamy, Chandrasingh J, Santosh Kumar, Antony Devasia, and Nitin Sudhakar Kekre Santhosh NagasubramanianSanthosh Nagasubramanian More articles by this author , Nirmal Thampi JohnNirmal Thampi John More articles by this author , Belavendra AntonisamyBelavendra Antonisamy More articles by this author , Chandrasingh JChandrasingh J More articles by this author , Santosh KumarSantosh Kumar More articles by this author , Antony DevasiaAntony Devasia More articles by this author , and Nitin Sudhakar KekreNitin Sudhakar Kekre More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2804AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lower urinary tract symptoms (LUTS) and erectile dysfunction increase with age and have a negative impact on quality of life. We aimed to compare efficacy and safety of tamsulosin versus combination of tamsulosin and tadalafil in male LUTS. METHODS This was a double blinded, parallel arm randomized controlled trial. Men >45 years with moderate LUTS, peak flow rate (Qmax) of 5-15ml/s were included. One arm received 0.4mg tamsulosin only (Group-A) while the second received 5mg tadalafil with tamsulosin (Group-B). Primary outcome was International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS QoL (quality of life), International Index for Erectile Function (IIEF-5) scores, Qmax and post void residual urine (PVRU). Block randomization was used. Placebo was used for blinding and allocation concealment. RESULTS Of 183 screened, 140 were randomized [70(Group-A), 70(Group-B)]; 116 - 82.85% [61(Group-A), 55(Group-B)] completed the study. Baseline characteristics were comparable. Difference in improvement in IPSS, IPSS QoL, IIEF and Qmax were 3 points (95% CI 0.7-5.3), 2 points (95% CI 1.5 - 2.5), 5 points (95% CI 3.4 - 6.6) and 2ml/s (95% CI 0.9 - 3.1) respectively in favour of the combination group. Difference in PVRU was not significant. There were no serious adverse events. Dropout rate due to adverse events was 2.85%. Myalgia (5 subjects) was the commonest adverse event in the combination group. CONCLUSIONS Combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Qmax compared to only tamsulosin without significant increase in adverse events. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1140-e1141 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Santhosh Nagasubramanian More articles by this author Nirmal Thampi John More articles by this author Belavendra Antonisamy More articles by this author Chandrasingh J More articles by this author Santosh Kumar More articles by this author Antony Devasia More articles by this author Nitin Sudhakar Kekre More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...