A Self-Selection Validation Study of the Uresta Bladder Support

Abstract

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.

Keywords: bladder support; pessary; root cause analysis; self-selection; stress urinary incontinence; women’s health.