Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device.

Introduction And Hypothesis: An intravaginal device (Uresta) is currently available for the treatment of stress urinary incontinence (SUI). Case-series data on its effectiveness exist; however, controlled data are lacking. The objective of this study is to determine the short-term efficacy of the Uresta device using a randomized placebo controlled trial. The hypothesis is that the Uresta device might significantly reduce urinary loss.

Methods: A single blind randomized controlled trial was conducted among women with urodynamic SUI recruited from a single urogynecology unit. Participants were randomized to receive the Uresta device or a placebo vaginal silastic ring placed high in the vagina for the duration of a pad test. Pad tests were performed before and after device placement. The primary outcome was the achievement of a 50 % or greater reduction in pad weight after device placement, in a comparison of the two groups. Sample size calculation showed a need for 18 subjects per group. Fisher's exact test was used to analyze the primary outcome. Research Ethics Board approval was obtained.

Results: Eighteen subjects per group completed the study protocol. The percentage of patients who achieved the primary outcome was 66.7 % in the Uresta group and 22.2 % in the placebo group (p = 0.01). The baseline demographic data were similar in the two groups. There were no adverse events during the test period.

Conclusions: The Uresta intravaginal continence device significantly reduces the short-term objective measures of urine loss due to SUI. Further study to assess subjective outcomes and long-term patient satisfaction is required.