Combination therapy appears more effective than single drug for lower urinary tract symptoms
Men with overactive bladder and lower urinary tract symptoms who received a combination therapy were more likely to report improvement in symptoms than men who received only one medication, according to a study in the November 15 issue of JAMA, a theme issue on men's health.
Steven A. Kaplan, M.D., of Weill Cornell Medical College, New York, presented the findings of the study today at a JAMA media briefing on men's health in New York.
Overactive bladder is a syndrome characterized by urinary urgency, usually with increased urination frequency during the day and night. An estimated 10 million men 40 years or older have symptoms consistent with overactive bladder, according to background information in the article. Lower urinary tract symptoms include urinary hesitancy and intermittency and weak urinary stream. Some men with these symptoms do not respond to treatment with common medications.
Dr. Kaplan and colleagues evaluated the effectiveness of two widely used medications, tolterodine extended release (ER), an antimuscarinic, and tamsulosin, an á1-receptor antagonist, used alone or in combination in men with overactive bladder and benign prostatic hyperplasia (enlarged prostate). The randomized, double-blind trial was conducted at 95 urology clinics in the United States involving men 40 years or older who had a self-rated bladder condition of at least moderate bother, and a bladder diary documenting urination frequency (8 or more urinations per 24 hours) and urgency (3 or more episodes per 24 hours), with or without urgency urinary incontinence. Patients were randomly assigned to receive placebo (n = 222), 4 mg of tolterodine ER (n = 217), 0.4 mg of tamsulosin (n = 215), or both tolterodine ER plus tamsulosin (n = 225) for 12 weeks. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.
The researchers found that 80 percent of patients receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12, compared with 62 percent of patients receiving placebo, 65 percent of patients receiving tolterodine ER, or 71 percent of patients receiving tamsulosin. Neither group receiving monotherapy demonstrated significant differences vs. placebo in percentages of patients reporting treatment benefit.
The symptoms of urgency urinary incontinence, urgency, and 24-hour and nocturnal urination frequency were also significantly improved by week 12 in the group receiving tolterodine ER plus tamsulosin vs. placebo but not in the tamsulosin group. In the tolterodine ER group, only urgency urinary incontinence episodes per 24 hours were significantly reduced at week 12. The International Prostate Symptom Score and quality-of-life scores were significantly improved by week 12 among patients receiving tolterodine ER plus tamsulosin. All interventions were well tolerated.
"The results of this study demonstrate that some men bothered by lower urinary tract symptoms, including bladder diary-documented overactive bladder symptoms, might not respond to monotherapy with either á-receptor antagonists or antimuscarinic agents. Treatment with tolterodine ER plus tamsulosin resulted in statistically and clinically significant treatment benefit. Similarly low incidences of acute urinary retention were observed in all treatment groups, and there were no significant differences in maximum urinary flow rate or postvoid residual volume between any 2 groups," the authors conclude.
(JAMA. 2006;296:2319-2328. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Note: This study was funded by Pfizer Inc. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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