UI can be caused by anatomic, physiologic and pathologic factors affecting the urinary tract. Subtypes of UI include urge incontinence, overflow incontinence and stress incontinence. Women with stress urinary incontinence (SUI) present clinically with involuntary loss of urine during coughing, sneezing, laughing, or other physical activities that increase intra-abdominal pressure. SUI is defined as urine loss coincident with sudden increase in intra-abdominal pressure. The most common cause of SUI in women is urethral hypermobility and may also be caused by an intrinsic urethral sphincter insufficiency (ISI). In ISI, the urethral sphincter is unable to generate enough resistance to remain completely closed to retain urine in the bladder, especially during stress manoeuvres. 

Treatment modalities available for patients with SUI can be divided into three major categories: behavioural, pharmacological and surgical. As a general rule, the first choice should be the least invasive treatment with the fewest potential adverse complications that is appropriate for the patient. Although a number of treatment options have been shown to be effective alone or in combination, more research is required to determine the optimum treatment combination for specific treatment groups (Urinary Incontinence in Adults, 1996). The high prevalence of UI and its significant adverse physical and psychological effects clearly justify more aggressive efforts to identify, evaluate and treat UI in all settings. The purpose of this study is to determine if a new incontinence device will provide an additional minimally invasive treatment option for women diagnosed with SUI. The new female incontinence device is designed for placement in the bladder to prevent urine leakage while allowing the patient to control urination naturally.