P49: Mid-Urethral Slings for Stress Urinary Incontinence: Effectiveness and Adverse Events Using Real-World Data
Poster Presenter
Vikas Kumar
Senior Data Scientist
OMNY Health United States
Objectives
To compare effectiveness and safety outcomes of the mini mid-urethral sling (MMUS) versus full-length mid-urethral sling (FMUS) in the treatment of women with stress urinary incontinence (SUI) in the real-world setting.
Method
Adult female patients from a large health system in the OMNY Health Medical Device Database with implantation of MMUS or FMUS were included. Proportions and risk differences (RD) with Hauck-Anderson confidence limits (CL) between cohorts for effectiveness and safety outcomes were computed.
Results
A total of 311 female patients with implantation of MMUS (N=235) or FMUS (N=76) were included. Distributions of age (62% ages 70 years and older), race (92% White), treatment setting (97% outpatient), body mass index (mean: 31.4 kg/m2), and baseline comorbidities (diabetes, cardiovascular, psychological, pulmonary, and musculoskeletal diseases) were similar between cohorts; however, FMUS patients were more likely to be retired or disabled (53% vs. 37%). For effectiveness outcomes, post-procedural SUI was slightly higher in the MMUS cohort (RD: -3.6%; 95% CL: -11.6%, 4.4%), urinary retention was slightly higher in the FMUS cohort (RD: 4.0%; 95% CL: -1.9%, 9.9%), and urinary frequency was similar between cohorts (RD: 0.0%; 95% CL: -3.6%, 3.7%). Notable differences in safety outcomes included post-procedural dysuria and/or obstructive uropathy, which was slightly higher in the MMUS cohort (RD: -3.4%; 95% CL: -4.0%, 0.6%), and pelvic pain, which was slightly higher in the FMUS cohort (RD: 4.0%; 95% CL: -2.6%. 10.6%). No notable differences between cohorts were observed in the other safety outcomes (infections, pain, and post-operative hemorrhaging), all of which yielded a point estimate of RD with magnitude less than 2%. The most common single adverse event was abdominal pain, which was observed in 9% of patients regardless of mid-sling implantation cohort. Due to rareness of outcome events, multivariable modeling was not pursued; however, analyses were repeated stratified by retired/disabled employment status and yielded similar results to those of the overall population.
Conclusion
MMUS tended to perform slightly better on some outcomes (post-procedural SUI and dysuria and/or obstructive uropathy) while FMUS tended to perform slightly better on other outcomes (urinary retention and pelvic pain). However, for most outcomes that were assessed, no notable differences were observed between cohorts. Although reported results were crude with no adjustment for potential confounding variables, baseline demographic and clinical characteristics were very similar between the two cohorts. Additionally, analyses stratified by retired/disabled employment status (the only baseline characteristic notably different between cohorts) yielded very similar results to those of the overall population. Thus, the influence of observed baseline variables on the results was likely minimal. Additional analyses in larger cohorts would be beneficial to understand further the association of mid-sling type on effectiveness and safety outcomes in the real-world setting.
