Efficacy and safety of polydimethylsiloxane injection (Macroplastique((R))) for the treatment of female stress urinary incontinence: results of a series of 85 patients with >= 3 years of follow-up

Objective: To assess the long-term efficacy and safety of polydimethylsiloxane injection (Macroplastique ® , Cogentix Medical, Orangeburg, New York, USA) for the treatment of female stress urinary incontinence (SUI), with a minimum follow-up of 3 years. Patients and Methods: This is an observational analytical prospective cohort study conducted in a single uro-gynaecological unit. All consecutive women with urodynamically confirmed pure SUI treated with the Macroplastique procedure, were included. Data regarding patient outcomes (International Consultation on Incontinence Questionnaire–Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure rates, and adverse events were collected during follow-up. Uni- and multivariable analyses were performed to investigate outcomes. Multiple logistic regression was performed to identify factors involved in the risk of failure of the procedures or recurrence of SUI. Results: In all, 85 women had the Macroplastique procedure. At the 3-year follow-up, all 85 (100%) patients were available for the evaluation. We did not find any significant change in the surgical outcomes during this time. At 3 years after surgery, 42 of 85 patients (49%) declared themselves cured (P = 0.67). Similarly, at the 3-year evaluation, 40 of 85 patients (47%) were objectively cured. There was no significant deterioration of objective cure rates over time (P = 0.3). A history of radical pelvic surgery and a low surgeon's skill were significantly associated with the risk of failure of Macroplastique. The multivariate analysis confirmed these findings; a previous history of radical pelvic surgery and a low surgeon's skill independently predicted the subjective and objective failure of Macroplastique. Conclusions: The 3-year results of this study showed that Macroplastique could be an acceptable alternative for the treatment of SUI with stable results over time and a negligible complication rate.