Corcos, J., et al. (2010). Poster, Society for Urodynamics and Female Urology, St. Petersburg, FL.
INTRODUCTION AND OBJECTIVE: This study evaluated the 24-month durability of the urethral bulking agent Macroplastique® for stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD) in women with previously documented successful outcomes at 12 months from their last injection.
METHODS: In a multicenter study, females diagnosed with SUI primarily due to ISD successfully treated with Macroplastique (defined as ≥1 Stamey grade improvement at 12 months from baseline) were followed for 12 additional months to assess their sustained therapeutic response. Outcome measures at 24-months included Stamey grade, Patient Global Impression of Improvement, Physician Assessment of Improvement, 1-hour pad weight, Incontinence Quality of Life (I-QOL) scores, and safety assessment.
RESULTS: At 24 months, 84% (56/67) of patients had sustained Stamey improvement from 12 months with 67% (45/67) dry (Stamey grade = 0). Of the dry patients at 12 months, 87% (33/38) maintained their cure at 24 months. Additionally, 41% (12/29) who were considered improved at 12 months were dry at 24 months. Overall I-QOL scores and all subscales showed improvements statistically significant (p<0.001) from baseline. Mean pad weight reduction was statistically significant (p<0.0001) at 24 months compared to baseline with 24 gm at baseline, 4 gm at 12 and 24 months. Both patient and physician assessments rated 85% of patients dry or markedly improved at 24 months from last treatment.
CONCLUSIONS: Substantial and durable results were sustained over two years with 84% of patients maintaining significant Stamey’s grade improvement from their 12-month assessment. At two years, 67% of patients were dry. The durability of Macroplastique demonstrates its effectiveness as a viable long-term therapy for female stress urinary incontinence primarily due to ISD. Macroplastique should be considered a reasonable first choice for urethral bulking due to its sustained efficacy over two years.
Source: Original Poster