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Nov. 14, 2006 -- Some men with overactive bladder may benefit from treatment with two drugs instead of one, a new study shows.
The study appears in The Journal of the American Medical Association.
The researchers included Steven Kaplan, MD, of the urology department at New York's Weill Cornell Medical College.
They studied 879 men with overactive bladder and enlarged prostateenlarged prostate (benign prostatic hyperplasia or BPH).
The men were at least 40 years old (average age: 61-63). They reported at least "moderate bother" from their overactive bladder.
Symptoms of overactive bladder include urgent feeling to urinate and increased frequency of urinating during the day and night. Men with BPH can experience overactive bladder symptoms as a result of their prostate enlargement.
Kaplan's team split the men into four groups.
For 12 weeks, each group followed one of these drug plans:
Treatment Benefits
The men kept diaries during the study of their bladder symptoms.
They were also asked if they had had any treatment benefits, and if so, how big those benefits were, after one, six, and 12 weeks of treatment.
Eighty percent of the men who took both Detrol LA and Flomax reported improvement by 12 weeks, compared with 62% of those taking the placebo.
For instance, they reported urinating once less per day and bigger gains in quality-of-life surveys than the placebo group.
The percentage of men reporting improvement who only took one drug -- Detrol LA or Flomax -- was similar to the percentage reporting improvement in the placebo group.
Dry mouth was the most commonly reported side effect, noted in 21% of the men on combination therapy and 7% of those taking only one drug.
The researchers call for longer studies of the combination drug therapy and they note a "large placebo response," possibly linked to the symptom diaries.
A journal editorial states that "although these findings may provide a treatment option for some men with lower urinary tract symptoms, the relatively short duration of the study (12 weeks) and the rather modest clinical benefits must be balanced against the potential for adverse effects that may occur with longer-term use of the drug combination."
The editorialists are Phil Fontana Rosa, MD, MBA, and Helene Cole, MD.
Fontana Rosa is executive deputy editor of The Journal of the American Medical Association. Cole is a contributing editor for the journal.
Kaplan's study was funded by Pfizer, which makes Detrol LA. Pfizer is a WebMD sponsor.
SOURCES: Kaplan, S. The Journal of the American Medical Association, Nov. 15, 2006; vol 296: pp 2319-2328. Fontana Rosa, P. The Journal of the American Medical Association, Nov. 15, 2006; vol 29: pp 2373-2375. News release, JAMA/Archives.