Duloxetine compared with placebo for the treatment of women with mixed urinary incontinence.
OBJECTIVE
Evaluate duloxetine in the treatment of women with mixed urinary incontinence (MUI).


METHODS
588 women, 19-85 years old with >or=4 incontinence episodes/week were randomly assigned to duloxetine 80 mg/day (N = 300) or placebo (N = 288). Patients were classified into three symptom subgroups: stress or urge predominant MUI (SPMUI or UPMUI) or balanced MUI (BMUI) based on their responses to the validated Stress/Urge Incontinence Questionnaire. Half the population was randomly assigned to have urodynamics; SPMUI, UPMUI, and BMUI condition diagnoses were based on signs, symptoms, and urodynamic observations. The primary outcome measure was the change in incontinence episode frequency (IEF). Secondary outcome measures included the Incontinence Quality of Life (I-QOL) scores, the ICI Quality of Life (ICIQ-SF) score, and the Patient Global Impression of Improvement (PGI-I) rating.


RESULTS
At baseline, women with SPMUI averaged 15.9 IEF/week (61% stress), those with UPMUI averaged 13.2 (70% urge), and those with BMUI averaged 16.5 (52% urge). Overall IEF decreases were significantly greater with duloxetine than placebo (median percent reduction 60% vs. 47%, P < 0.001); both UUI and SUI episodes were significantly decreased with duloxetine (median SUI IEF reduction 59% vs. 43%, P = 0.001; UUI IEF reduction 58% vs. 40%, P < 0.001). Duloxetine IEF decreases were significantly greater for patients with SPMUI conditions and symptoms and for those with UPMUI conditions but not symptoms. Significant benefits were also demonstrated with duloxetine for improvements in I-QOL total score (11.5 points vs. 8.1 points, P = 0.002), all three I-QOL subscale scores, and for the ICIQ-SF score (-2.6 vs. -1.7, P = 0.002) as well as for PGI-I ratings (much/very much better 44.2% vs. 27.3%, P = 0.001).


CONCLUSIONS
Duloxetine demonstrated significant efficacy in this population of women with MUI.
Bent
Alfred E
AE
Greater Baltimore Medical Center, Baltimore, Maryland, USA.
Gousse
Angelo E
AE
Hendrix
Susan L
SL
Klutke
Carl G
CG
Monga
Ash K
AK
Yuen
Chui K
CK
Muram
David
D
Yalcin
Ilker
I
Bump
Richard C
RC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008875:Middle Aged; D014179:Neurotransmitter Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States; D014550:Urinary Incontinence, Stress / Q000188:drug therapy* / Q000503:physiopathology; D053202:Urinary Incontinence, Urge / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics
D014179:Neurotransmitter Uptake Inhibitors; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride