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

Int J Clin Pract. 2020 Aug;74(8):e13530. doi: 10.1111/ijcp.13530. Epub 2020 Jun 15.


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 improvement differences not being significant (P = .552 and P = .131, respectively).Improvements in QOL index were more significant in the tamsulosin group (mean difference -2.3 vs -3.06 P = .010).The adverse effects were minor and were managed symptomatically without any drug discontinuity.

Conclusions: In summary, therefore, we may conclude that that once daily monotherapy with tadalafil 5 mg or tamsulosin 0.4 mg was equally efficacious in the management of moderate to severely bothersome LUTS in majority of patients as a result of BPH. The role of Tadalafil monotherapy in BPH patients with predominant storage LUTS merits further evaluation with larger trials.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adrenergic alpha-1 Receptor Antagonists / therapeutic use*
  • Aged
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lower Urinary Tract Symptoms / etiology
  • Male
  • Middle Aged
  • Prostatic Hyperplasia / complications
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / embryology
  • Quality of Life
  • Tadalafil / therapeutic use*
  • Tamsulosin / therapeutic use*
  • Treatment Outcome
  • Urological Agents / therapeutic use*


  • Adrenergic alpha-1 Receptor Antagonists
  • Urological Agents
  • Tadalafil
  • Tamsulosin