A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence

Abstract

Introduction and hypothesisMacroplastique® (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.MethodsA 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.ResultsImprovement 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.ConclusionsThis 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.

Outcomes of Macroplastique injections for stress urinary incontinence after suburethral sling removal

“…A meta‐analysis by Ghoniem and Miller reported a success rate of 64% at 18 months after MPQ in women with SUI 15 . Other long‐term findings have been reported by Tamanini et al 7 who used postoperative VLPP to establish a cure/improvement rate of 73% in 15 women followed for 60 months.…”

Urethral bulking agents versus other surgical procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis

“…In fact, the moderate quality of these studies and the great heterogeneity did not allow a fair comparison between groups. In 2013, two reviews article on the efficacy of bulking agents were published [8,9]. Davis et al, in a descriptive review that included 45 articles on bulking agents for the treatment of SUI, concluded that in carefully selected patients, injectable biomaterials represent feasible alternatives to open surgical procedures as primary and secondary treatment options for SUI [8].…”

“…In the only currently available meta-analysis on the urethral bulking agents, Ghoniem and Miller considered only data focusing on one type of material (polydimethylsiloxane injection) and included a great proportion of non-randomized studies [9].…”

Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety

“…We found a rate of serious complications (Clavien-Dindo >2) of 18% in the GH group and 26% in the TRC, mainly due to the removal of (a part of) the implants under local or general anesthesia. In the meta-analysis of Ghoniem [23], no serious adverse events were recorded. In a systematic review performed by Kasi et al [24] in 2016, 8 studies were included with a total of 767 patients who were treated with Bulkamid ® .…”