PMID- 32012409
OWN - NLM
STAT- MEDLINE
DCOM- 20201028
LR  - 20201028
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 125
IP  - 5
DP  - 2020 May
TI  - Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract 
      symptoms: a double-blinded, randomised controlled trial.
PG  - 718-724
LID - 10.1111/bju.15027 [doi]
AB  - OBJECTIVE: To compare the efficacy and safety of tamsulosin vs the combination of 
      tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS). PATIENTS 
      AND METHODS: This was a double-blinded, parallel-arm randomised controlled trial. 
      Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q(max) ) 
      of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), 
      while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary 
      outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes 
      were IPSS quality of life (QoL) score, five-item version of the International 
      Index of Erectile Function (IIEF-5) score, Q(max) , and post-void residual urine 
      (PVR). Block randomisation was used. Placebo was used for blinding and allocation 
      concealment. Intention-to-treat analysis was used for outcome measures. RESULTS: 
      Of the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 
      (82.85%) (61 in Group-A, 55 in Group-B) completed the study. Baseline 
      characteristics were comparable. The improvements in the IPSS, IPSS QoL score, 
      IIEF score and Q(max) were -1.69 (95% confidence interval [CI] -1.4 to -2.0), 
      -0.70 (95% CI -0.60 to -0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) 
      respectively, in favour of the combination group. The difference in PVR was not 
      significant. There were no serious adverse events (AEs). The dropout rate due to 
      AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination 
      group. CONCLUSION: The combination of tamsulosin and tadalafil produced 
      significantly better improvements in LUTS, QoL, erectile function and Q(max) 
      compared to monotherapy with tamsulosin, without an increase in AEs.
CI  - (c) 2020 The Authors BJU International (c) 2020 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Nagasubramanian, Santhosh
AU  - Nagasubramanian S
AUID- ORCID: 0000-0002-5944-3899
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - John, Nirmal Thampi
AU  - John NT
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - Antonisamy, Belavendra
AU  - Antonisamy B
AD  - Department of, Biostatistics, Christian Medical College, Vellore, India.
FAU - Mukha, Rajiv Paul
AU  - Mukha RP
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - Jeyachandra Berry, Chandra Singh
AU  - Jeyachandra Berry CS
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - Kumar, Santosh
AU  - Kumar S
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - Devasia, Antony
AU  - Devasia A
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
FAU - Kekre, Nitin Sudhakar
AU  - Kekre NS
AD  - Departments of, Department of, Urology, Christian Medical College, Vellore, 
      India.
LA  - eng
SI  - CTRI/2015/09/006226
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200227
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Adrenergic alpha-1 Receptor Antagonists)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
RN  - G3P28OML5I (Tamsulosin)
SB  - IM
MH  - Adrenergic alpha-1 Receptor Antagonists/therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Follow-Up Studies
MH  - Humans
MH  - Lower Urinary Tract Symptoms/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase 5 Inhibitors/therapeutic use
MH  - *Quality of Life
MH  - Retrospective Studies
MH  - Tadalafil/*therapeutic use
MH  - Tamsulosin/*therapeutic use
MH  - Treatment Outcome
MH  - Urination/*drug effects
OTO - NOTNLM
OT  - #UroBPH
OT  - erectile dysfunction
OT  - lower urinary tract symptoms
OT  - phosphodiesterase inhibitors
OT  - tadalafil
OT  - tamsulosin
EDAT- 2020/02/06 06:00
MHDA- 2020/10/29 06:00
CRDT- 2020/02/04 06:00
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2020/10/29 06:00 [medline]
PHST- 2020/02/04 06:00 [entrez]
AID - 10.1111/bju.15027 [doi]
PST - ppublish
SO  - BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27.