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Effect of a Vaginal Device on Quality of Life With Urinary Stress Incontinence

From the Incontinence Clinic, Department of Urology, Hvidovre Hospital, University of Copenhagen, and the Department of Gynecology and Obstetrics, Glostrup County Hospital, University of Copenhagen, Glostrup, Denmark.

Address reprint requests to: Pia Sander, MD, The Incontinence Clinic, Department of Urology, Hvidovre Hospital, University of Copenhagen, Kohavevej 19, Vedbaek 2950, Denmark

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.