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AUA 2019

AUA 2019: Long-term Safety and Efficacy of Polydimethylsiloxane in Patients with SUI

Chicago, IL (UroToday.com) This is a retrospective review of prospectively collected data of 276 subjects enrolled in a multicenter study between October 2008-August 2017. Ghoniem et al showed durability of Macroplastique (MPQ) success up to 2 years. They aimed to evaluate the safety and efficacy of MPQ in women with SUI due to intrinsic sphincteric deficiency (ISD) who completed a 3-year follow-up in this post market study.

Subjects were treated with up to two MPQ injections and 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. Success is defined as improvement to Stamey grade 0 or 1 at 36 months. Safety assessment is reported on serious and non-serious adverse events (AE). Two-sided binomial test was used to test the overall success rate, while linear mixed effect model with patient-level random effect was used to examine longitudinal trends over the 3-year study period.

The majority of patients were white with mean age 63.3 years. At 36 months 21/70 (30%) of patients reported Stamey grade 0 and 28/70 (40%) had Stamey grade 1. Overall satisfaction was 68% at 36 months. 27/70 (38.5%) patients report they were very satisfied on PGI-S at 36 months. I-QoL scores and the subscales were significantly improved at 12, 24 and 36 months from baseline (p < 0.0001) and remained stable. The composite success rate (QoL, PGI-S and Stamey grade improvement) was 51.4%. Transient dysuria 3.2%, hematuria 6%, pain at the injection site 1.6% and urinary tract infection 2% were the most common AE that occurred within the first 3 months’ post injection. No serious AE were reported.

At 3 years, MPQ is safe and efficacious for the treatment of SUI secondary to ISD in women. The overall satisfaction is sustained from baseline to 3 years post injection.

I QOL AUA 2019


Presented by: Gamal Ghoniem  MD, FACS, ABU/FPMRS, University of California Irvine

Co-authors: Bilal Farhan MD, Mashrin Chowdhury DO, Orange, CA, Yanjun Chen MS, Irvine, CA

Written by: Bilal Farhan, MD, Clinical Instructor, Female Urology and Voiding Dysfunction, Department of Urology, University of California, Irvine Twitter: @BilalfarhanMD at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois