Introduction and hypothesis: Macroplastique® (polydimethylsiloxane injection) is a minimally invasive urethral bulking agent with global clinical literature describing its use over 20 years. This study critically assessed the safety and effectiveness outcomes for adult women treated with Macroplastique for stress urinary incontinence (SUI) through a systematic review and meta-analysis.
Methods: A systematic review of the scientific literature from 1990 to 2010 was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to quantitatively summarize the safety and effectiveness of Macroplastique for female SUI. A total of 958 patients from 23 cohorts were eligible for inclusion and were analyzed. Random-effects models were used to estimate the improvement and cure rates following treatment at three time periods: short-term (<6 months), mid-term (6-18 months), and long-term (>18 months). Expanded models assessed the effect of reinjection rate on successful treatment outcomes. Adverse event rates were aggregated and reported.
Results: Improvement rates were 75 % [95 % confidence interval (CI), 69-81] in the short-term, 73 % (95 % CI, 62-83) in the mid-term, and 64 % (95 % CI, 57-71) long-term. Cure/dry rates were 43 % (95 % CI, 33-54), 37 % (95 % CI, 28-46), and 36 % (95 % CI, 27-46) over the same respective follow-up periods. Higher study reinjection rates were associated with improved long-term SUI outcomes. No serious adverse events were reported.
Conclusions: This quantitative review supports Macroplastique as an effective, durable, and safe treatment option for female SUI. Meta-analytic evidence suggests that long-term therapeutic benefit is frequently maintained, with some patients requiring reinjection.