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Prospective randomized controlled study directly comparing tadalafil and tamsulosin for male patients with lower urinary tract symptoms

T. Takeuchi, S. Toyokawa, Yumiko Okuno, N. Ishida, M. Yamagoe, M. Zaitsu, K. Mikami

bioRxiv, 2018

Abstract

Lower urinary tract symptoms are widespread in elderly men and often suggestive of benign prostatic hyperplasia (LUTS/BPH). A randomized, prospective, and open-labeled trial directly comparing the effects of tadalafil (a phosphodiesterase 5 inhibitor) 5 mg once daily and tamsulosin (an α1-blocker) 0.2 mg once daily for 12 weeks in LUTS/BPH patients was conducted. Data were recorded before randomization as well as at 4, 8, and 12 weeks after medication. Fifteen patients allocated tadalafil and 20 allocated tamsulosin completed 12 weeks of medication. Total IPSS, IPSS voiding, and IPSS-QOL scores declined with medication, but there was no difference between drugs. IPSS storage scores reduced more in the tamsulosin group than tadalafil group. OABSS did not decline significantly with medication. IIEF5 was maintained in the tadalafil group, but declined in the tamsulosin group. The maximum flow rate and post-void residual urine volume did not significantly change with medication. Daytime, night-time, and 24-hour urinary frequencies as well as the mean and largest daytime, night-time, and 24-hour voiding volumes per void did not significantly change with medication. In conclusion, tamsulosin was more effective to reduce storage symptoms than tadalafil. Tadalafil had the advantage of maintaining the erectile function.

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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