Combination therapy for men with lower urinary tract symptoms

Kaplan SA et al. (2006) Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder. JAMA 296: 2319–2328

Lower urinary tract symptoms and overactive bladder are commonly treated with antimuscarinic agents or α-receptor antagonists. Kaplan et al. investigated the efficacy and safety of the antimuscarinic tolterodine extended release (ER), the α₁-receptor antagonist tamsulosin, and a combination of both, in men with overactive bladder and benign prostatic hyperplasia.

In this 12-week, randomized, double-blind, placebo-controlled trial at 95 clinics in the US, patients received a single daily dose of tolterodine ER 4 mg (n = 217), tamsulosin 0.4 mg (n = 215), tolterodine ER plus tamsulosin (n = 225), or placebo (n = 222). The primary outcome measure was patient perception of benefit after 12 weeks of treatment. Other end points included bladder diary variables, International Prostate Symptom Scores (IPSS), safety, and tolerability.

With regard to efficacy, 80% of patients receiving tolterodine ER plus tamsulosin had perceived a benefit from their treatment, compared with 62% receiving placebo, 65% receiving tolterodine ER, and 71% receiving tamsulosin. Patients receiving tolterodine ER plus tamsulosin experienced significant reductions in urgency urinary incontinence, urgency episodes, and micturitions per 24 h compared with patients receiving placebo. They also had significant improvements in the IPSS (P = 0.003) compared with placebo patients. All three interventions were well tolerated.

The results of this study indicate that combined treatment with an antimuscarinic agent and an α₁-receptor antagonist for 12 weeks is beneficial for men with lower urinary tract symptoms, including overactive bladder, who might not respond to monotherapy with either agent.