OBJECTIVE: To assess the efficacy of silicone microimplants (Macroplastique; polydimethylsiloxane) therapy for stress urinary incontinence in adult women, using a systematic review of identified studies. MATERIALS AND METHODS: A computer-aided and manual search for published studies investigating silicone microimplants therapy for stress urinary incontinence in adult women. The methodological quality of the included studies was assessed using criteria based on generally accepted principles of interventional research. RESULTS: Only two RCTs, only published as an abstract, were found. Eleven pre-experimental or observational studies were identified. Overall, the methodological quality was low. The main methodological shortcomings of the studies were: no random allocation procedure, lack of prestratification on prognostic determinants, no blinding, small sample sizes, and lack of proper analysis and presentation of results. There was variability in the indication for implantation, implantation procedure, rate and volume of silicone microimplants. The use of different outcome measures in most of the trials made comparison between studies difficult. CONCLUSIONS: Because of the low methodological quality of included studies, results should be interpreted with caution and no firm conclusions about the efficacy of silicone microimplants were possible. Randomized clinical trials, using valid and reliable subjective and objective measurements, are necessary to establish the efficacy of silicone microimplants therapy in treating stress urinary incontinence in adult women.
OBJECTIVE: To assess the efficacy of silicone microimplants (Macroplastique; polydimethylsiloxane) therapy for stress urinary incontinence in adult women, using a systematic review of identified studies. MATERIALS AND METHODS: A computer-aided and manual search for published studies investigating silicone microimplants therapy for stress urinary incontinence in adult women. The methodological quality of the included studies was assessed using criteria based on generally accepted principles of interventional research. RESULTS: Only two RCTs, only published as an abstract, were found. Eleven pre-experimental or observational studies were identified. Overall, the methodological quality was low. The main methodological shortcomings of the studies were: no random allocation procedure, lack of prestratification on prognostic determinants, no blinding, small sample sizes, and lack of proper analysis and presentation of results. There was variability in the indication for implantation, implantation procedure, rate and volume of silicone microimplants. The use of different outcome measures in most of the trials made comparison between studies difficult. CONCLUSIONS: Because of the low methodological quality of included studies, results should be interpreted with caution and no firm conclusions about the efficacy of silicone microimplants were possible. Randomized clinical trials, using valid and reliable subjective and objective measurements, are necessary to establish the efficacy of silicone microimplants therapy in treating stress urinary incontinence in adult women.