The study design is unique since it includes all patients who completed 3 years follow-up after the last injection of the urethral bulking agent (UBA) Macroplastique®. While it is a strong design to offer the longitudinal, not cross-sectional, outcome it doesn’t include all ROSE study patients at the time of analysis, i.e., patients with less than 3 years and drop-outs.
The 5-year analysis of the ROSE study will be performed soon including all patients enrolled. The success rate is 70% with 30% of patients dry. We also included a much stricter composite outcome which is a 51.4% success rate. The value of the latter outcome is combining quality of life measures with Stamey grade improvement giving the reader a realistic counseling tool.
Long-term data of UBA outcomes is needed. The concept of the temporary effect of UBA is challenged by our results and few others showing durable results. UBA injections offer an alternative to mid-urethral slings in some patients as mesh issues and complications are scrutinized by FDA and different communities across the globe. The study showed the stability of success over time with a great safety profile.
Written by: Gamal Ghoniem, MD, FACS, FPMRS, Department of Urology, University of California Irvine (UCI), Irvine, CA, USA.
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