Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence

• Published in: Maturitas 2008-06, Vol.60 (2), p.138-147
• Main Authors: Schagen van Leeuwen, Jules H, Lange, Rainer R, Jonasson, Aino Fianu, Chen, Wei J, Viktrup, Lars
• Format: Article
• Language: English
• Subjects: Aged; Biological and medical sciences; Cognition; Double-Blind Method; Duloxetine; Duloxetine Hydrochloride; Elderly women; Female; Humans; Internal Medicine; Medical sciences; Medicin och hälsovetenskap; Nephrology. Urinary tract diseases; Obstetrics and Gynecology; Pharmacology. Drug treatments; Quality of Life; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Stress urinary incontinence; Thiophenes - adverse effects; Thiophenes - therapeutic use; Treatment Outcome; Urinary Incontinence, Stress - drug therapy; Urinary system; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland
• ISSN: 0378-5122; 1873-4111
• DOI: 10.1016/j.maturitas.2008.04.012

Abstract Objectives To evaluate the efficacy and safety of duloxetine in community-dwelling women ≥65 years with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) versus placebo. Methods Patients were randomly assigned for 12 weeks to placebo ( N = 134) or duloxetine ( N = 131) (20 mg twice daily [BID] for 2 weeks and 40 mg BID for an additional 10 weeks), followed by a double-blind 4-week dose de-escalation/discontinuation phase. The primary efficacy variable was the percent change in incontinence episode frequency (IEF) from baseline to endpoint. Other variables included absolute IEF change, responder rate, changes in mean time between voids (MTBV), weekly continence pad usage, the impact of treatment on quality of life, patient's global impression of improvement (PGI-I), and changes in depression and cognition. Results Duloxetine-treated patients had a significantly greater decrease from baseline to endpoint in mean IEF/week than placebo-treated patients (−52.47% vs. −36.70%, P < 0.001). The IEF responder rate (≥50% reduction in IEF/week) was 57.1% in the duloxetine group and 35.2% in the placebo group ( P < 0.001). Significant benefits of duloxetine were also demonstrated for weekly continence pad usage ( P = 0.011), MTBV ( P < 0.001), incontinence quality of life questionnaire (I-QOL) scores ( P < 0.001), and PGI-I ratings ( P < 0.001). Patients with depressive symptoms and cognitive impairments were few and changes were insignificant. The proportion of patients with ≥1 treatment-emergent adverse event (TEAE) was similar with both treatments, but dry mouth, fatigue, constipation, and hyperhidrosis were significantly more common in women taking duloxetine. Conclusions Duloxetine is a safe and effective treatment for elderly women with symptoms of SUI or S-MUI.