Presentation Authors: Gamal Ghoniem MD, FACS, ABU/FPMRS*, Bilal Farhan MD, Mashrin Chowdhury DO, Orange, CA, Yanjun Chen MS, Irvine, CA
Introduction: Macroplastique (MPQ) is a urethral bulking agent used in the treatment of stress urinary incontinence (SUI) in women with intrinsic sphincter deficiency (ISD). Ghoniem et al showed durability of MPQ success up to 2 years. The purpose of this study is to evaluate the safety and efficacy of MPQ in women with SUI due to ISD who completed a 3 year follow-up in this post market study.
Methods: This is a retrospective review of prospectively collected data of 276 subjects enrolled in a multicenter study between October 2008-August 2017. 70 subjects completed 3 years of follow up. 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.
Results: 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.
Conclusions: 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.
Source of Funding: Unrestricted grant from Cogentix