Abstract
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.
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Funding
Dr. Alexis Dieter was awarded a UNC IBM Faculty Development Award to provide support the study at the University of North Carolina at Chapel Hill site.
Dr. Silpa Nekkanti was awarded an Ohio State FAME Institutional Grant to provide support the study at the Ohio State Wexner Medical Center site.
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Nekkanti, S., Wu, J.M., Hundley, A.F. et al. A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence. Int Urogynecol J 33, 861–868 (2022). https://doi.org/10.1007/s00192-021-04967-9
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DOI: https://doi.org/10.1007/s00192-021-04967-9