A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

Introduction And Hypothesis: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts.

Methods: This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled.

Results: Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred.

Conclusions: Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.