Treatment with the Reliance urinary control insert: one-year experience.

The 1-year experience of 63 women using an intraurethral insert for the management of stress or mild mixed urinary incontinence is presented, emphasizing safety and efficacy. Objective criteria, including standardized pad weight tests and patient diaries, were employed to evaluate the device's effectiveness. At study outset, 82% of the patients were completely dry with the device in situ, with an additional 16% of patients significantly improved. At 12 months, 79% of the patients were completely dry, and 16% were significantly improved. This result is consistent with the significant improvement (P < 0.0001) in the number of urinary incontinence episodes reported in patient diaries. Women reported that the device significantly improved their ability to stay dry over a number of routine and physically demanding daily activities. The device was increasingly easy to use and more comfortable over time (P < 0.0001). The latter finding was confirmed by a decline in patient reports of "sensation of device presence" over the duration of the study (35% at 1 week v 7% at 12 months). Untoward events included gross hematuria (24%), device-related bladder mucosal irritation (9%), and symptomatic bacteriuria (30%). Such side effects were expected for this type of device, were easily managed without significant medical intervention, and did not result in any long-term clinical sequelae. The great reduction in the number of episodes of urinary incontinence, the low rate of significant problems associated with device use, and ease of use make the intraurethral insert a useful management alternative for women with stress urinary incontinence.