title: Sildenafil citrate in combination with tamsulosin versus tamsulosin monotherapy for management of male lower urinary tract symptoms due to benign prostatic hyperplasia: A randomised, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To assess the additive effect of sildenafil citrate to tamsulosin in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) in men with or without erectile dysfunction (ED).
  
  
  METHODS
  In all, 150 men with untreated LUTS/BPH with or without ED were randomised to receive sildenafil 25 mg once daily (OD) or placebo OD (night time) combined with tamsulosin 0.4 mg OD (day time) for 6 months. Changes from pre-treatment scores in International Prostate Symptom Score (IPSS), IPSS-quality of life (QoL) score, maximum urinary flow rate (Qmax), and the five-item version of the International Index of Erectile Function questionnaire (IIEF-5) were assessed at 3 and 6 months. Safety profiles were assessed by physical examination and monitoring clinical adverse events.
  
  
  RESULTS
  Group A comprised of men who received tamsulosin and sildenafil (75 men), whilst those in Group B received tamsulosin and placebo (75). The IPSS was significantly improved in Group A compared to Group B, at -29.3% vs -13.7% (P= 0.039) at 3 months and -37% vs -19.6% (P= 0.043) at 6 months after treatment.Qmaxsignificantly improved in both groups compared with before treatment (P< 0.001). The IIEF-5 scores improved more in Group A than in Group B, at 58.7% vs 11.7% at 3 months and 62.4% vs 12.4% at 6 months after treatment (bothP< 0.001).
  
  
  CONCLUSIONS
  Sildenafil citrate combined with tamsulosin improved LUTS, erectile function, and patient QoL more than tamsulosin monotherapy with the merit of a comparable safety profile in patients with LUTS/BPH.
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Amr
authors.initials: A
authors.lastname: Fawzi
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Kamel
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Emad
authors.initials: E
authors.lastname: Salem
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Esam
authors.initials: E
authors.lastname: Desoky
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Omran
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Hazem
authors.initials: H
authors.lastname: Elgalaly
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Sakr
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Aref
authors.initials: A
authors.lastname: Maarouf
authors.affiliation: Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
authors.forename: Salem
authors.initials: S
authors.lastname: Khalil
keywords: BMI, body mass index; Benign prostatic hyperplasia (BPH); CONSORT, Consolidated Standards of Reporting Trials; ED, erectile dysfunction; IIEF-5, five-item version of the International Index of Erectile Function questionnaire; Lower urinary tract symptoms (LUTS); NO, nitric oxide; OD, once daily; PDE5-I, phosphodiesterase type 5 inhibitor; Qmax, maximum urinary flow rate; QoL, quality of life; RCT, randomised controlled trial; SMD, standardised mean difference; Sildenafil; Tamsulosin