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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.
- Source :
-
Arab journal of urology [Arab J Urol] 2016 Dec 29; Vol. 15 (1), pp. 53-59. Date of Electronic Publication: 2016 Dec 29 (Print Publication: 2017). - Publication Year :
- 2016
-
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).<br />Patients and 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 ( Q <subscript>max</subscript> ), 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.<br />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. Q <subscript>max</subscript> significantly 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 (both P  < 0.001).<br />Conclusion: 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.
Details
- Language :
- English
- ISSN :
- 2090-598X
- Volume :
- 15
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Arab journal of urology
- Publication Type :
- Academic Journal
- Accession number :
- 28275519
- Full Text :
- https://doi.org/10.1016/j.aju.2016.11.001