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

Abstract

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.

Keywords: #Incontinence; bulking agents; injectable; long-term follow-up; stress urinary.