A Disposable Intravaginal Device for the Management of Stress Urinary Incontinence

ABSTRACT

Urinary incontinence affects many women over the age of 50 with a substantial detrimental effect on daily activities and the quality of life. Surgical treatments are invasive, expensive, and not always successful. Patients are also treated with a variety of nonsurgical therapies (physical therapy, pharmaceutical interventions, and various vaginal and urethral inserts), but these have poor compliance rates and limited efficacy in patients with mild to moderate stress urinary incontinence (SUI). Incontinence pessaries have demonstrated efficacy in the treatment of SUI but can cause vaginal erosion, foul vaginal odors, and other complications associated with their prolonged residence in the vagina. A novel disposable intravaginal device, which can be worn during active hours and then discarded, was evaluated in this study for safety, ease of use, and efficacy in the treatment of SUI. Fifty-seven women with an average of one episode of SUI per day were fitted with the device, allowed to acclimate to wearing it during the day, and then asked wear the device and pre-weighed incontinence pads for 12 hours a day.

Use of this device was significantly associated with a statistically significant decrease in SUI episodes, a decrease in unintentional urine output, a decrease in self-reported bladder control difficulty, and a self-reported improvement in quality of life. Subjects rated the comfort of device use during the fitting period, as well as during later device usage. No serious adverse events were reported. Results show that the intravaginal device is safe, relatively comfortable, and effective at reducing the frequency and psychosocial impact of SUI.