Safety and efficacy of polydimethylsiloxane (Macroplastique®) in women with stress urinary incontinence: analysis of data from patients who completed three years follow-up

Gamal Ghoniem, Bilal Farhan, Mashrin Lira Chowdhury, Yanjun Chen

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Introduction and hypothesis: This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Methods: This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed. Results: The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up. Conclusions: MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.

Original languageEnglish (US)
Pages (from-to)2835-2840
Number of pages6
JournalInternational Urogynecology Journal
Volume32
Issue number10
DOIs
StatePublished - Oct 2021

Keywords

  • Intrinsic sphincter deficiency
  • Polydimethylsiloxane
  • Three years
  • Urethral bulking agent

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Urology

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