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
-- 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
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
"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.