New disposable vaginal device (continence guard) in the treatment of female stress incontinence. Design, efficacy and short term safety.

BACKGROUND

To develop a new disposable vaginal device for use during the daytime, and test its efficacy and short-term safety in the treatment of stress incontinence.

METHODS

The intravaginal support device was designed from polyurethane, a foam product with documented high tissue compatibility. It was tested in 26 women with the symptom of stress incontinence. Before and after one month's use of the device, a 24-hour home pad weighing test, uroflowmetry, postvoid residual urine and a 3-days voiding diary were made. A questionnaire about the subjective effect and adverse events was filled in. In vitro and in vivo microbiology testing were performed.

RESULTS

Four women discontinued the treatment because of discomfort or difficulties in using the device. Out of 22 women who completed the study nine (41%) were subjectively cured of incontinence, ten (45%) improved while three (14%) claimed unchanged incontinence. With the device in place all had decreased leakage at the 24-hour pad weighing test and unchanged urodynamic tests. The subjective complaints were few, and no vaginal or urinary infections were found. All women whose condition both subjectively and objectively improved, (19/22) wanted to continue treatment with the device.

CONCLUSIONS

The new disposable vaginal device is effective in alleviating the symptoms of stress incontinence. It is well accepted and safe.