Elsevier

Urology

Volume 53, Issue 1, January 1999, Pages 71-76
Urology

Adult Urology
Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL) 1,

https://doi.org/10.1016/S0090-4295(98)00454-3Get rights and content

Abstract

Objectives. To report on the further development of the Incontinence Quality of Life Instrument (I-QOL), a self-report quality of life measure specific to urinary incontinence (UI), including its measurement model, responsiveness, and effect size.

Methods. Incontinent female patients (141 with stress, 147 with mixed UI) completed the I-QOL and comparative measures at screening, pretreatment, and four subsequent follow-up visits during participation in a multicenter, double-blind, placebo-controlled, randomized trial assessing the efficacy of duloxetine. Psychometric testing followed standardized procedures.

Results. Factor analysis confirmed an overall score and three subscale scores (avoidance and limiting behaviors, psychosocial impacts, and social embarrassment). All scores were internally consistent (alpha = 0.87 to 0.93) and reproducible (ICC = 0.87 to 0.91). The pattern of previously reported correlations with the Short-Form 36-item Health Survey and Psychological Well-Being Schedule were confirmed. Responsiveness statistics using changes in the independent measures of stress test pad weight, number of incontinent episodes, and patient global impression of improvement ranged from 0.4 to 0.8. Minimally important changes ranged from 2% to 5% in association with these measures and effect sizes.

Conclusions. In a clinical trial, the I-QOL proved to be valid, reproducible, and responsive to treatment for UI in women.

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

References (28)

  • L.C Yu

    Incontinence stress indexmeasuring psychological impact

    J Gerontol Nurs

    (1987)
  • Cella D: Functional Assessment of Incontinence Therapy, version 2. Chicago, Rush Division of Psychosocial Oncology,...
  • S Hunskaar et al.

    The quality of life in women with urinary incontinence as measured by the sickness impact profile

    J Am Geriatr Soc

    (1991)
  • U Renck-Hooper et al.

    Measuring quality of life in female urinary urge incontinencedevelopment and psychometric properties of the IQOLI

    Outcomes Res

    (1997)
  • Cited by (415)

    View all citing articles on Scopus

    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.

    1

    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].

    View full text