E-Posters-Long- term Safety and Efficacy of Polydimethylsiloxane (Macroplastique®) in Female Patients with Stress Urinary Incontinence: Analysis of Patients who completed 3- Years of Treatment

Long- term Safety and Efficacy of Polydimethylsiloxane (Macroplastique®) in Female Patients with Stress Urinary Incontinence: Analysis of Patients who completed 3- Years of Treatment - Gamal M. Ghoniem, MD, FACS

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This document presents a study analyzing the long-term safety and efficacy of Macroplastique (MPQ), a urethral bulking agent, in the treatment of stress urinary incontinence (SUI) in women. The study enrolled 276 subjects, of which 70 completed a 3-year follow-up. The subjects were treated with up to two MPQ injections and assessed using the Stamey grade and I-QoL questionnaire at baseline, 12, 24, and 36 months post-injection. Patient Global Impression of Satisfaction (PGI-S) was measured at 36 months. The success rate was defined as improvement to Stamey grade 0 or 1 at 36 months. <br /><br />The study found that at 36 months, MPQ was safe and efficacious for the treatment of SUI. Overall satisfaction remained stable from baseline to 3 years post-injection. The composite success rate, based on subjective outcomes and Stamey grade improvement, was 51.4%. Common adverse events within the first 3 months included transient dysuria, hematuria, pain at the injection site, and urinary tract infections, but no serious adverse events were reported. <br /><br />The study highlights the sustainability of subjective satisfaction over time, even with repeat injections. Though objective measures such as pad weight or urodynamic testing could be used, the study found that validated questionnaires like the I-QoL and PGI-S are sufficient for evaluating subjective outcomes. The ease of administration of MPQ through a minimally invasive, endoscopic route contributes to its low risk and favorable safety profile.<br /><br />The document also notes that MPQ is made of a silicone elastomer with unique properties that prevent migration once implanted. Previous studies have demonstrated the durability of MPQ up to 2 years, with high success rates and improvement in incontinence.<br /><br />In conclusion, MPQ is a safe and effective treatment for SUI in women with ISD, with sustained overall satisfaction and significant improvements in quality of life. The study acknowledges the centers involved in the research and provides a list of them.

Keywords

Macroplastique

urethral bulking agent

stress urinary incontinence

women

long-term safety

efficacy

Stamey grade

I-QoL questionnaire

Patient Global Impression of Satisfaction

success rate