Adult UrologyQuality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL) 1☆,
Section snippets
Study sites, recruitment, and participation
Incontinent female patients (141 with stress, 147 with mixed UI) were recruited for participation in a multicenter, double-blind, placebo-controlled, randomized clinical study to assess the efficacy of duloxetine in the treatment of patients with stress and mixed incontinence. Eligibility criteria included significant leakage and discrete incontinent episodes during the 2 to 3 weeks before randomization. Major exclusion criteria included diabetic neuropathy, congenital urologic disorders,
Sample characteristics
Two hundred eighty-eight women participated in the trial. Seventy-six percent were 45 years of age or older; 93% were white; 72% had UI between 1 and 10 years in duration (24% for over 10 years); and 58% stated that they had not seen a doctor in the past year for UI (Table I). In accordance with the study design, approximately one-half of the participants were diagnosed with stress incontinence (n = 141 [49%]); the remaining participants (n = 147 [51%]) reported symptoms consistent with a mix
Comment
Using data from a large, randomized clinical trial assessing treatment for UI in women, we demonstrated that the I-QOL shows good internal consistency, reproducibility, and validity, as reported previously using cross-sectional data.10 The I-QOL is capable of discriminating between different levels of perceived severity, use of medical services, and frequency of incontinent episodes, as well as different levels of stress test pad weight, a commonly used clinical outcome measure.15
Correlations
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This research was funded by research contracts from Eli Lilly and Company to Donald L. Patrick. Drs. Yalcin and Buesching are employees of Eli Lilly and Company. Drs. Patrick, Martin, Bushnell, and Wagner have no financial stake in Eli Lilly and Company and were paid consultants to Eli Lilly and Company for this study.
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For a copy of the I-QOL and permission to use it, please contact Carol Andrejasich at Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, or [email protected].