Treatment of female stress urinary incontinence with a new anatomically shaped vaginal device (Conveen Continence Guard).

OBJECTIVE

To evaluate the clinical efficacy of a new vaginal device for the treatment of female stress urinary incontinence.

PATIENTS AND METHODS

This multicentre study comprised 90 women with stress incontinence (mean age 47.5 years, range 31-65). The diagnosis of stress urinary incontinence was based on the result of a quantitative provocation test. The device was used daily for 4 weeks. Urinary leakage with and without the device was assessed using a 24 h pad-test at home. The patient's subjective opinion concerning their urinary leakage and the efficacy and function of the device were assessed using a questionnaire.

RESULTS

Eighty-five women completed the study and successfully performed the pad test on both occasions. The mean (SEM) urinary leakage at the end of the study period whilst using the device was 13.9 (3.2) mL, which was less than the 41.6 (7.6) mL mean leakage measured before treatment (P < 0.001). Of the 85 women, 39 (46%) were completely dry during the pad test with the device in situ, 29% had a smaller leakage, 17% had the same leakage and 8% had a greater leakage. Accordingly, the overall objective improvement was 75%; 72% of the women considered the product to function satisfactorily and 60% expressed a wish to continue with the treatment. The vaginal device caused some local discomfort in 62% of the patients, but 72% of these women wished to continue with the device despite the reported discomfort.

CONCLUSION

The new vaginal device reduced urinary leakage in stress incontinent women and 46% became continent. Even women with severe leakage had some improvement when using the device.