Preliminary results on the off-label use of duloxetine for the treatment of stress incontinence after radical prostatectomy or cystectomy

Objectives: Stress urinary incontinence (SUI) is a common compliant of patients after pelvic surgery. To date, no pharmacotherapy for men is available, but duloxetine, a combined serotonin and norepinephrine reuptake inhibitor, has been successfully introduced and tested for SUI in women. The aim of our study was to evaluate if duloxetine is safe and effective for men with stress incontinence after radical prostatectomy or cystectomy. Methods: Twenty patients were included in our study, 15 after radical prostatectomy and 5 after radical cystectomy and orthotopic ileal neo-bladder reconstruction. Each patient reported at least 3 wk of SUI despite doing consequent pelvic floor exercises. After exclusion of a urinary tract infection, we administered 40 mg duloxetine twice daily for a mean of 9.4 wk (range: 1-35 wk). Results: After duloxetine, the average daily use of incontinence pads was lowered significantly (p < 0.001) from 8.0 (+/- 6.5) to 4.2 (+/- 5.9). Seven patients were completely dry or used one pad daily at most. Most patients reported mild side effects such as fatigue or a dry mouth, but these symptoms vanished after a short time. Six patients, however, had severe side effects, mainly massive fatigue or insomnia, and discontinued using duloxetine. Conclusions: Our preliminary results suggest that duloxetine is effective in men with SUI after prostatectomy or cystectomy. Further prospective studies with more patients included and a longer follow-up are recommended. (c) 2006 Elsevier B.V. All rights reserved.