title: Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial.
abstract: BACKGROUND
  Alpha blockers are prescribed to manage lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Antimuscarinics are prescribed to treat overactive bladder (OAB).
  
  
  OBJECTIVE
  To investigate the safety of a combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS) in men with LUTS and bladder outlet obstruction (BOO).
  
  
  METHODS
  Randomized, double-blind, parallel-group, placebo-controlled study in men aged >45 yr with LUTS and BOO for ≥3 mo, total International Prostate Symptom Score (IPSS) ≥8, BOO index ≥20, maximum urinary flow rate (Q(max)) ≤12 ml/s, and voided volume ≥120 ml.
  
  
  METHODS
  Once-daily coadministration of TOCAS 0.4 mg plus SOLI 6 mg, TOCAS 0.4 mg plus SOLI 9 mg, or placebo for 12 wk.
  
  
  METHODS
  Primary (safety) measurements: Q(max) and detrusor pressure at Q(max) (P(det)Q(max)). Other safety assessments included postvoid residual (PVR) volume. Secondary end points included bladder contractile index (BCI) score and percent bladder voiding efficiency (BVE). An analysis of covariance model compared each TOCAS plus SOLI combination with placebo.
  
  
  CONCLUSIONS
  Both active treatment groups were noninferior to placebo at end of treatment (EOT) for P(det)Q(max) and Q(max). Mean change from baseline PVR was significantly higher at all time points for TOCAS 0.4 mg plus SOLI 6 mg, and at weeks 2, 12, and EOT for TOCAS 0.4 mg plus SOLI 9 mg versus placebo. Both treatment groups were similar to placebo for BCI and BVE. Urinary retention was seen in only one patient receiving TOCAS 0.4 mg plus SOLI 6 mg. Limitations of the study were that prostate size and prostate-specific antigen level were not measured.
  
  
  CONCLUSIONS
  TOCAS 0.4 mg plus SOLI 6 mg or 9 mg was noninferior to placebo at EOT for P(det)Q(max) and Q(max) in men with LUTS and BOO, and there was no clinical or statistical evidence of increased risk of urinary retention.
authors: Weill Medical College of Cornell University, New York-Presbyterian Hospital/Weill Cornell Medical Center, NY, USA. kaplans@med.cornell.edu
authors: Steven A
authors: SA
authors: Kaplan
authors: Weizhong
authors: W
authors: He
authors: William D
authors: WD
authors: Koltun
authors: Jana
authors: J
authors: Cummings
authors: Tim
authors: T
authors: Schneider
authors: Allam
authors: A
authors: Fakhoury
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000704:Analysis of Variance; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011312:Pressure; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D001748:Urinary Bladder Neck Obstruction / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D013449:Sulfonamides; D044005:Tetrahydroisoquinolines; D000077409:Tamsulosin; D000069464:Solifenacin Succinate