Urinary Incontinence (UI) is defined as a condition in which a demonstrable involuntary loss of urine has become a social or hygienic problem. The World Health Organisation estimates that 200 million people worldwide are affected by urinary incontinence.

Stress incontinence occurs when the urinary sphincter does not stay closed when there is an increase in pressure in the abdomen, leading to urine leakage. As an example, coughing, sneezing, laughing, or running can cause episodes of stress incontinence. Stress incontinence is the most common cause of urinary incontinence in younger women, the second most common cause in older women, and may occur in older men after certain types of prostate surgery.

The economic effects of urinary incontinence are significant. A study investigating the annual direct costs in the USA estimated it as being $16.3 billion US dollars and the NHS in the UK has estimated an annual direct cost of £1.4 billion per annum to treat urinary incontinence.

There is a compelling clinical need for a discreet, indwelling, effective device that prevents urinary leakage in patients.