Efficacy and safety of tadalafil vs tamsulosin in lower urinary tract symptoms (LUTS) as a result of benign prostate hyperplasia (BPH)-open label randomised controlled study
Abstract
INTRODUCTION & AIM: Several newer medications have emerged for the management of lower urinary tract symptoms secondary to benign prostate hyperplasia (BPH). The efficacy/safety of PDE-5 inhibitors (Tadalafil 5 mg) in BPH-lower urinary tract symptoms (LUTS) has been sparingly assessed in the published English literature as compared with their established role in erectile dysfunction. We aim to assess the efficacy/safety of tadalafil vs tamsulosin in symptomatic patients of BPH in a tertiary care teaching institution.
METHODS: After obtaining an informed written consent and institutional ethics clearance, 100 patients of BPH with an IPSS score of more than 7, without any complications of the disease were computer randomised to receive therapy with either tamsulosin 0.4 mg or tadalafil 5 mg once daily for a period of 2 months. They were evaluated for its efficacy (IPSS, Peak flow rate, IIEF-5, quality of life index [QOL] and PVR) and safety (side effect profile) with monthly visit assessments for 2 months. Data were analysed statistically using ANOVA and unpaired t-tests.The protocol was registered with the CTRI/2018/03/012825.
RESULTS: Patients in both groups were comparable on basis of their demographic data, renal function, PSA and baseline efficacy parameters. Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096). Similar trends were seen with peak flow rate and PVR with intergroup…
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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. Reported size: 100 participants or records.
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