Long-term efficacy and safety of a disposable vaginal device (continence guard) in the treatment of female stress incontinence.

The aim of the study was to evaluate the long-term efficacy and safety of a new disposable vaginal device in the treatment of female stress incontinence. Nineteen out of 22 women with stress incontinence were subjectively and objectively cured or improved in a short-term study, and continued the treatment with the device for 1 year. All 19 completed the study: 13 (68%) were subjectively dry, 5 (26%) were improved and 1 (5%) reported unchanged incontinence. All but 1 had decreased leakage at the 24-hour pad test, and 67% a greater than 50% decrease. No significant changes were found in the other urodynamic tests. The gynecologic examination showed no signs of irritation or erosion from the device, and the subjective complaints were modest and few. It was concluded that the disposable vaginal device maintains its positive effect in alleviating the symptoms of stress incontinence in the long term, it is safe and patient compliance is good.