Incontinent men will do better on both tolterodine (Detrol) and tamsulosin (Flomax) than on either drug alone, urologists report.
In the first study of its kind, urologists enrolled 754 men aged 40 years or older who had benign prostatic hyperplasia (BPH) and overactive bladder.
The men were randomly assigned to receive placebo, one of the two drugs, or both drugs. At the end of the 12-week study, 80% of those on both drugs reported improvement compared with 62% of those receiving placebo, 71% receiving tamsulosin, and 65% receiving tolterodine. Men taking both drugs also reported significant improvement in their prostate symptom score, a measure of BPH. The improvements in the monotherapy groups did not reach statistical significance compared with placebo, whereas the results in the combined therapy group did.
Both drugs, either individually or in combination, were well-tolerated, with dry mouth the most common side effect in all three treatment groups.
The researchers attributed the placebo group’s impressive response to the requirement that all the participants in the study complete bladder diaries, which they called a “training effect.” In fact, they said the placebo group “cannot be viewed as a nontreatment group.”
The results were presented at a New York City symposium sponsored by JAMA, in which the study was published (2007;296:2319-2328). The trial was funded by Pfizer, maker of Detrol.