Effect of a vaginal device on quality of life with urinary stress incontinence.

Abstract Objective: To assess the effect of a vaginal device (Continence Guard) on urine leakage and quality of life. Methods: Fifty-five women with stress incontinence participated in a 3-month study. They were assessed by the Incontinence Impact Questionnaire, two incontinence-related quality-of-life questions, a generic quality-of-life questionnaire (Short Form-36), two 24-hour home pad weighing tests, a 2-day voiding diary, uroflowmetry, urine cultures, and a questionnaire about subjective effectiveness of the device. Results: Forty-one (74.5%) women completed the study. Estimated on an intent-to-treat basis, the vaginal device was associated with subjective cure in 11 women (20%) and improvement in 27 (49%). The mean 24-hour pad test leakage and leakage episodes in the voiding diary decreased significantly. Fifty-eight percent of the 55 women enrolled wanted to continue using the device after 3 months. The quality of life measured by the Incontinence Impact Questionnaire showed highly significant improvement, and the results of the two incontinence-related quality of life questions also showed significant improvement. Responses to the Short Form-36 general health questionnaire showed no significant changes. Improvement on the Incontinence Impact Questionnaire correlated with improvements in incontinence, whereas the Short Form-36 scores were unchanged. Conclusion: Treatment with the Continence Guard significantly decreases leakage and improves quality of life in women with symptoms of urinary stress incontinence. An incontinence-specific, rather than a generic, quality-of-life questionnaire was important in assessing treatment outcomes.