A new external urethral occlusive device for female urinary incontinence

Determine the efficacy of a new external anti-incontinence urethral device.

A before-after 1 month trial, open longitudinal study of 155 women complaining of urinary incontinence recruited from a referral urogynecology practice and local media advertising was performed. Primary outcomes included assessing the efficacy of the device using visual analogue scales, quality-of-life questionnaires, 1- and 48-hour standardized pad tests, and voiding diary. Secondary outcomes consisted of the evaluation of the adverse effects and the clinical profile of patients willing to use the device after study completion.

Ninety-six (62%) of 155 women enrolled completed the study. Scores on the visual analogue scales improved for the symptoms of stress incontinence, urgency, and urge incontinence (P < .001). The score for irritation/discomfort increased (P < .001). Data from diaries showed that 38 (44%, n = 86) patients were dry. Of 454 recorded patient-days, 325 (72%) were dry days. On pad testing, incontinence was cured in 49% (1-hour pad test, n = 59, P < .001) and 44% (48-hour pad test, n = 32, P < .001) of patients. Quality-of-life scores were significantly improved in 48% (n = 96, Incontinence Impact Questionnaire, P < .001) and 32% (n = 96, Urogenital Distress Inventory, P < .001) of patients. There was no increase in bacteriuria. After study completion, 61 (39%) women chose to continue using the device, but this was not predictable from baseline data.

Use of this device resulted in a significant reduction in incontinence and improvement in quality-of-life issues with minimal adverse events in the majority of women. This new anti-incontinence device could become a useful addition to the armamentarium of nonsurgical options.