A Self-Selection Validation Study of the Uresta Bladder Support.

OBJECTIVES

When a medical device is available over the counter, the ability of a consumer to correctly self-select to use the device, independent of guidance from a health care professional, is essential and important. This study was undertaken to evaluate the self-selection process for the Uresta Bladder Support.

METHODS

A total of 49 women were enrolled in this study. The results of a self-selection interview were validated by using a gynaecologic examination as the gold standard.

RESULTS

The urinary continence diagnoses broke down as follows: continent 16 (33%), pure stress incontinence 18 (37%), mixed urinary incontinence 13 (27%), and pure urge incontinence 2 (4%). A total of 36 (73%) indicated that they would acquire the bladder support and use it, whereas 13 (27%) indicated that they would not choose to use the device based on their understanding of the device and their personal medical history. A total of 43 (88%) made a correct self-selection decision and 6 (12%) made an incorrect decision. Root cause analysis found that the residual risks associated with use of the Uresta Bladder Support in the over-the-counter context were acceptable and outweighed by the impact of the device on user's quality of life.

CONCLUSIONS

Using the information provided on the external packaging of the Uresta Bladder Support, most users will make a correct self-selection decision regarding the use of the product to manage their incontinence symptoms.