title: A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
abstract: BACKGROUND
  Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction are common disorders of advancing age.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH.
  
  
  METHODS
  In this prospective randomized study, 133 men complaining of LUTS due to BPH were included. Forty-five patients received tamsulosin 0.4 mg/day alone (Group A), 44 patients received tadalafil 10 mg/day (Group B), and combination therapy (tamsulosin and tadalafil both) was instituted in 44 patients (Group C). After a 2-week medication free run-in period, they were evaluated for International Prostatic Symptom Score (IPSS), International Index of Erectile Function score (IIEF5), quality of life (IPSS QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR) volume, and safety parameters before and at 3 months of treatment.
  
  
  METHODS
  There were primary (IPSS, IPSS QoL index, Qmax, and PVR) and secondary (erectile function [EF] domain scores from IIEF5) efficacy end points. Safety assessment included laboratory tests and patient's reporting of adverse event.
  
  
  RESULTS
  A significant improvement in IPSS score was observed in all the 3 groups A, B, and C (-50.90%, P < 0.05; -33.50%, P < 0.05; and -53.90%, P < 0.05, respectively). IIEF5 score increased significantly in these three groups (+39.28%, P < 0.05; +45.96%, P < 0.05; and +60.23%, P < 0.05, respectively). A significant increase in Qmax and decrease in PVR were also observed (33.99%, P < 0.05; 29.78%, P < 0.05; and 37.04%, P < 0.05) and (-60.90%, P < 0.05; -49.45%, P < 0.05; and -62.97%, P < 0.05, respectively). The QoL scores improved significantly (-73.35%, P < 0.05; -70.26%, P < 0.05; and -79.65%, P < 0.05, respectively). Side effects were dyspepsia, heartburn, headache, flushing, myalgia, and backache. Adverse effect dropout was 3.7%. No participant experienced any severe or serious adverse events.
  
  
  CONCLUSIONS
  In patients with LUTS due to BPH, tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS. Their EF also improves with these medications. The improvement is better with combination therapy compared with single agent alone.
authors.affiliation: Department of Urology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
authors.forename: Dig Vijay
authors.initials: DV
authors.lastname: Singh
authors.forename: Uttam Kumar
authors.initials: UK
authors.lastname: Mete
authors.forename: Arup Kumar
authors.initials: AK
authors.lastname: Mandal
authors.forename: Shrawan Kumar
authors.initials: SK
authors.lastname: Singh
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D002243:Carbolines / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications*; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D000068581:Tadalafil; D000077409:Tamsulosin; D016896:Treatment Outcome; D016055:Urinary Retention / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D013449:Sulfonamides; D000068581:Tadalafil; D000077409:Tamsulosin
keywords: Benign Prostatic Hyperplasia; Erectile Dysfunction; Lower Urinary Tract Symptoms; Medical Therapy; Tadalafil; Tamsulosin