A Self-selection validation study of the Uresta Bladder Support.

Introduction And Hypothesis: While evidence of efficacy and safety is the foremost concern of consumers and healthcare professionals who use a medical device, when the device is available over-the-counter the ability of a consumer to correctly self-select to use the device, independent of guidance from a healthcare professional, is equally essential and important. To date there has been no formal examination of the process of self-selection of the Uresta Bladder Support or any other urinary incontinence pessary. The current study was undertaken to evaluate the self-selection process for the Uresta Bladder Support.

Results: Forty-nine women were enrolled in this study. 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%). Thirty-six (73%) indicated that they would acquire the bladder support and use it while 13 (27%) indicated that they would not choose to use the device based on their understanding of the device and their personal medical history. Forty-three (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 were 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 use of the product to manage their incontinence symptoms.