Uroplasty Highlights Results From Clinical Study On Macroplastique(R) For The Treatment Of Stress Urinary Incontinence

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 14 Jan 2009 - 1:00 PDT

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Uroplasty, Inc. (Amex: UPI) highlighted results from a clinical study of Macroplastique for the treatment of female stress urinary incontinence, now available in the January 2009 Journal of Urology. This is the first, large, multicenter randomized trial comparing the safety and efficacy of Macroplastique to another bulking agent used in the control group. In the Macroplastique group, the dry/cure rate was 36.9% versus 24.8% in the control group, with a 61.5% improvement compared to 48%, respectively. The authors conclude Macroplastique is a safe, effective, minimally invasive material that can be administered on an outpatient basis.

"This study shows the clear benefits of Macroplastique, an injectable soft tissue urethral bulking agent, bringing the majority of treated patients either freedom from unwanted urinary leakage or fewer episodes," said Uroplasty Chief Executive Officer and President David Kaysen. "Some other commercially available bulking agents may be absorbed into the body, potentially diminishing their clinical benefit. Macroplastique implants are suspended in a water-soluble gel that, once removed from the body, leaves behind the soft, flexible permanent elastomer implants that can sustain the treatment's benefits and provide patients with an improved outcome."

Macroplastique has been available to treat this condition worldwide since 1991. The majority of women treated with Macroplastique report a cure or improvement in their symptoms, with many seeing that improvement as soon as they leave the doctor's office, hospital or clinic.

The study, titled "Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: Results of a multicenter, randomized, controlled, single-blind study," followed 122 Macroplastique patients 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 credits eleven other participating investigative sites in North America.

About Uroplasty, Inc.

Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our primary focus is the continued commercialization of our Urgent PC system, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of urinary urgency, urinary frequency and urge incontinence - symptoms often associated with overactive bladder. We also offer Macroplastique(R) Implants, an injectable bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. Please visit Uroplasty, Inc. at http://uroplasty.com.

For complete information regarding Macroplastique indications, contraindications, warnings, precautions, instructions for use, storage, adverse reactions and disclaimer of warranties, please refer to the instructions for use brochure available at the Uroplasty website.

Uroplasty Inc.
http://uroplasty.com

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