Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence.
OBJECTIVE
To evaluate the efficacy and safety of duloxetine in community-dwelling women > or =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) (20mg 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 (> or =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 > or =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.
Schagen van Leeuwen
Jules H
JH
Secretariaat Gynaecologie F1, Antonius Hospital, Koekoekslaan 1, Nieuwegein, The Netherlands. j.schagen@Antonius.net
Lange
Rainer R
RR
Jonasson
Aino Fianu
AF
Chen
Wei J
WJ
Viktrup
Lars
L
D000368:Aged; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes