SUFU 2019: Long-Term Safety and Efficacy of Polydimethylsiloxane (MACROPLASTIQUE®) in Patients with Stress Urinary Incontinence: Analysis of Patients Who Completed 3-Years of Treatment

Miami, FL ( ¼ of women experience urinary incontinence and prevalence may actually be higher around the world. Urethral bulking agents have been studied since the 1930s. 

Several different materials have been studied, collagen being one however does not sustain.  Polydimethylsiloxane is a solid silicone elastomer suspended in a gel. It has been studied and  shown to be non allergenic.

This is a post-market approval study of the use of a urethral bulking agent, polydimethylsiloxane, for stress urinary incontinence. This is a prospective, multicenter study in patients who completed 3 years of follow up post injection. 276 subjects were enrolled and 70 subjects completed all 3 years of follow up.

Subjects were treated with up to two injections.  The study enrollment period was October 2008-August 2017. Subjects were then followed at 3,12, 24, and 36 months. Stamey grade (0= continent, 1= incontinence with vigorous activity, 2= incontinence with minimal activity and 3= total incontinence) and I-QoL questionnaire divided into 3 subscales were assessed at baseline, 12, 24,and 36 months post injection. Patient Global Impression of Satisfaction (PGI-S) was assessed at 36 months. They defined success as an improvement to Stamey grade 0 or 1 at 36 months.

They found the majority of patients were white (n=67) with mean age 63.3 years. 

At the end of the 3 years or 36 months, 21/70 (30%) of patients reported Stamey score 0 and 28/70 (40%) had Stamey score 1. The composite success rate was 51.4% at 36 months..  The quality of life total score and subscales significantly improved from baseline to12 months, then progressing to 24 and 36 months the quality of life maintained itself.  27/70 (38.5%) patients report very satisfied on PGI-S at 36 months vs 32/68 (47%) at 12 months. Overall satisfaction was 68% at 36 months and 72% at 12 months. 

The most common adverse events occurred within the first 3 months as transient dysuria 3.2%, hematuria 6%, pain at the injection site 1.6% and urinary tract infection 2 %. They did not report any serious adverse events. The composite scored is assumed to be lower than overall as patients may have altered their physical activity therefore not capturing a subjective improvement. 
UroToday SUFU2019 Polydimethylsiloxane 1

At 3 years, Macroplastique urethral bulking agent is safe and efficacious for the treatment of stress incontinence from intrinsic sphincter deficiency. The overall satisfaction is sustained from baseline to 3 years post injection.

Presented by: Mashrin Lira Chowdhury, DO, The University of California Irvine Department of Urology

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