Duloxetine may be effective for treating stress urinary incontinence (SUI) and improving quality of life (QoL) in men who have had a radical prostatectomy, a study shows.
The drug, which inhibits reuptake of serotonin and noradrenalin, previously has been shown to be effective for treating SUI in women. The new study is the first randomized controlled trial of duloxetine as a treatment of SUI in men.
Researchers led by Jean-Nicolas Cornu, MD, of Tenon Hospital in Paris, enrolled 31 men with postprostatectomy SUI and randomly assigned 16 men to receive 80 mg of duloxetine daily and 15 to receive matching placebo for three months. Following randomized, visits were scheduled at two, four, eight, and 12 weeks (visit 5). The primary outcome measure was the relative variation in incontinence episodes frequency (IEF).
Patients who received duloxetine experienced a mean 52.2% reduction in IEF from baseline compared with a 19% increase with placebo, which was a significant mean difference of 71.2% between the groups, according to results published online ahead of print in European Urology. The researchers observed significant IEF improvements with duloxetine versus placebo after eight and 12 weeks, but not at four weeks.
As measured by the Incontinence Quality of Life questionnaire, QoL improved in the duloxetine-treated patients compared with placebo recipients, but the difference between the groups was significant only at visit 5 after 12 weeks of treatment, the investigators reported. Compared with the placebo group, the duloxetine-treated patients also had significant improvement in total scores on the Incontinence Impact Questionnaire Short Form, Urogential Distress Inventory Short Form, and question 3 of the International Consultation on Incontinence/World Health Organization Short Form questionnaire (Question 3 asks patients to rate on a 0-10 scale how much leaking urine interferes with their everyday life.)
“Duloxetine is the first potentially widely approved pharmacologic treatment for postprostatectomy incontinence that fills an unmet medical need for patients who want to postpone or avoid surgery,” the investigators concluded.