Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial

Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.

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).

Design, setting, and participants: 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.

Interventions: 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.

Outcome measurements and statistical analysis: 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.

Results and limitations: 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.

Trial registration: ClinicalTrials.gov NCT00507455.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic alpha-1 Receptor Antagonists / adverse effects
  • Adrenergic alpha-1 Receptor Antagonists / therapeutic use*
  • Aged
  • Analysis of Variance
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Lower Urinary Tract Symptoms / diagnosis
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lower Urinary Tract Symptoms / physiopathology
  • Male
  • Middle Aged
  • Muscarinic Antagonists / adverse effects
  • Muscarinic Antagonists / therapeutic use*
  • Pressure
  • Quinuclidines / adverse effects
  • Quinuclidines / therapeutic use*
  • Solifenacin Succinate
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Tamsulosin
  • Tetrahydroisoquinolines / adverse effects
  • Tetrahydroisoquinolines / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Urinary Bladder / drug effects*
  • Urinary Bladder / physiopathology
  • Urinary Bladder Neck Obstruction / diagnosis
  • Urinary Bladder Neck Obstruction / drug therapy*
  • Urinary Bladder Neck Obstruction / physiopathology
  • Urodynamics / drug effects

Substances

  • Adrenergic alpha-1 Receptor Antagonists
  • Muscarinic Antagonists
  • Quinuclidines
  • Sulfonamides
  • Tetrahydroisoquinolines
  • Tamsulosin
  • Solifenacin Succinate

Associated data

  • ClinicalTrials.gov/NCT00507455