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Uroplasty Highlights Results From Clinical Study on Macroplastique(R) for the Treatment of Stress Urinary Incontinence
Date:1/13/2009

atients and a control group of 125 that received a commercially available bioabsorbable urethral bulking agent for one year.

  • Of the 247 study patients in the study, the average age was approximately 61 years, 73% were post-menopausal, about one fourth had previous failed urinary incontinence surgery, and over 50% had hysterectomies.
  • In the Macroplastique group, the dry/cure rate was 36.9% compared to 24.8% in the control group.
  • After 12 months, 61.5% of Macroplastique patients had improved 1 Stamey grade (a measure of incontinence improvement) compared to 48% of control patients.
  • The Macroplastique group's one-hour pad weight decrease was 25.4 ml from baseline compared to 22.8 ml for the control group.
  • Mean improvement for Macroplastique patients, in Urinary Incontinence Quality of Life Scores (I-QOL), was 28.7 compared to 26.4 for control patients.

An abstract of the study is available at: http://www.jurology.com/article/S0022-5347(08)02452-X/abstract

"I am pleased to have collaborated with leading Urologists and Urogynecologists throughout North American in conducting this study of Macroplastique," said Gamal Ghoniem, MD, Head, section of Voiding Dysfunction, Female Urology and Reconstruction and Chairman of Medical Education at Cleveland Clinic Florida and the study's primary author. "After treatment with Macroplastique, we measured clinical improvement to a patient's condition using a number of widely accepted outcome measures including cure rates, pad weight tests, and quality of life questionnaires. As a result, this study provides strong scientific evidence of the effectiveness of Macroplastique for the treatment of stress urinary incontinence.

In addition to Dr. Ghoniem, the study cred
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SOURCE Uroplasty, Inc.
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