Macroplastique effective for stress urinary incontinence in women

Published on March 4, 2010 at 5:10 AM · No Comments

Uroplasty, Inc. (NYSE Amex: UPI) highlighted results from a two-year, multicenter clinical study of Macroplastique that will be published in the April 2010 print edition of The Journal of Urology(R). The 24-month study evaluated the durability of Macroplastique for stress urinary incontinence in women with previously documented success at 12 months. Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant improvement from their 12-month assessment. Additionally, 67% of the patients implanted with Macroplastique were dry at the 24-month follow-up visit.

"This study clearly demonstrates that Macroplastique provides a high level of long-term effectiveness," said Uroplasty Chief Executive Officer and President David Kaysen. "The effectiveness means major improvements in quality of life for women who previously suffered from unwanted urinary leakage. While other urethral bulking agents may be absorbed into the body, potentially diminishing their clinical benefit, Macroplastique is composed of a permanent silicone elastomer that contributes to sustained, measurable patient improvement," added Mr. Kaysen.

The study, titled "Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results" followed 67 Macroplastique patients with successful outcomes at 12 months for up to 24 months. Highlights of the study include:

-- 84% of patients had sustained success from 12 months to 24 months -- 67% of patients were dry at 24 months -- Of the 38 dry patients at 12 months, 87% maintained their cure at 24 months -- 41% who were considered improved at 12 months were dry at 24 months -- Overall "Incontinence Quality of Life" scores and all subscale scores showed statistically significant improvements -- Patient and physician assessments rated 85% of patients dry or markedly improved at 24 months

"This long term, multicenter study of Macroplastique demonstrated sustained results over two years," said Dr. Gamal Ghoniem of the Cleveland Clinic Florida and the study's primary author. "Using widely accepted outcome measures, we confirmed that patients sustained clinical improvements over a prolonged period of time. This positively impacted their quality of life and delayed the need for further treatment. This study further supports the strong scientific evidence of the effectiveness of Macroplastique for the treatment of stress urinary incontinence," concluded Dr. Ghoniem.

Macroplastique is an injectable soft-tissue urethral bulking agent for treating adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

Macroplastique is made up of two parts - a water-soluble gel that is absorbed and removed from the body in urine and a synthetic, rubber-like, silicone elastomer implant material that is permanent and not absorbed by the body. This permanent material causes the bulking effect around the urethra after implantation.

"The study highlighted the durability and efficacy of Macroplastique, which has been the leading urethral bulking agent in Europe for over 18 years," added Mr. Kaysen. "Macroplastique is being used by urologists across the United Stated because it offers sustained clinical results. We anticipate the Macroplastique market share to continue to grow as physicians and patients search for lasting solutions for female stress urinary incontinence," concluded Mr. Kaysen.

SOURCE Uroplasty, Inc.
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