Data presented at the 3rd International Consultation on Incontinence (ICI) congress in Monte Carlo, Monaco, provide evidence for the efficacy of duloxetine in the treatment of women with stress urinary incontinence (SUI).

Results from a worldwide, four-study meta-analysis, comparing the efficacy of duloxetine versus placebo in the treatment of more than 1,900 women with SUI, demonstrated a statistically significant improvement after 12 weeks in duloxetine treated women, compared to placebo (p<0.001). This improvement was evident in a number of analyses, including the reduction in frequency of incontinence episodes and the improvement in the quality of life scores.

SUI is a common and bothersome medical condition, which affects up to 1 in 7 women worldwide1 and has a significant impact on quality of life. SUI, the most common form of urinary incontinence, is the accidental leakage of urine due to coughing, sneezing, laughing or physical activity such as lifting or exercising.

The results come from a meta-analysis of four double-blind, placebo-controlled studies, which enrolled a total of 1,913 women, at 186 study sites in Africa, Australia, Europe, North America, and South America. Patients were studied for 12 weeks, followed by an open-label extension period for one year.

The results from the 12-week double-blind period of these studies show that approximately two thirds of women treated with duloxetine reported feeling better. 82 per cent of women who continued treatment in the open label extension for one year considered themselves better (both using a validated patient global impression of improvement tool).

Speaking at the International Consultation on Incontinence, professor Philip van Kerrebroeck, University Hospital, Maastricht, NL, said, "Although common, SUI is not normal at any age and has a profoundly negative impact on a woman's quality of life. The duloxetine study results presented provide physicians with hope that for the first time there may be a pharmaceutical treatment specifically indicated for SUI, that is effective in reducing the symptoms of this medical condition and consequently could improve our patients' quality of life."

Additional data presented confirm the safety of duloxetine for the treatment of women with SUI. Side effects tend to be mild or moderate, occur early in treatment, and tend to be non-progressive and transient in nature. The most common side effect was nausea. Other less prevalent side effects included dry mouth, fatigue, insomnia, constipation, headache, dizziness, somnolence, and diarrhea.

Duloxetine is a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine, which are believed to play a key role in the normal closure of the urethral sphincter, the weakening of which can result in SUI. By increasing neurotransmitter concentration, duloxetine is believed to increase the tone and contraction of the urethral sphincter, which helps to prevent accidental urine leakage.

The duloxetine clinical research programme is a long-term, extensive and evolving global initiative, sponsored by Eli Lilly and Company and Boehringer Ingelheim.