Phase 2 Clinical Study Demonstrates Safety and Efficacy of Vitala™ Continence Control Device

Diseases of the Colon & Rectum Publishes Data Supporting Innovative Pouchless Ostomy Management System for People with a Colostomy

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ConvaTec

Nov 30, 2010, 04:00 ET

SKILLMAN, N.J., Nov. 30, 2010 /PRNewswire/ -- Vitala™ a novel, non-invasive continence control device, demonstrated safety and efficacy in providing up to 8 hours of temporary continence to people with an end colostomy, according to results of a study published in the journal Diseases of the Colon & Rectum.(1)

Developed by ConvaTec, a world-leading developer of innovative medical technologies for community and hospital care, the Vitala™ Continence Control Device (CCD) allows individuals to manage their colostomy without a pouch, belt or irrigation. The single-use, disposable disc-shaped device, which is worn together with the ConvaTec Natura® skin barrier (1-3/4" or 2-1/4"), is currently available in select European markets, where it is indicated for use up to 12 hours daily.

"People with a colostomy experience many challenges in adapting to life after surgery, often profoundly impacting their quality of life," said lead study investigator Terri Maxwell, RN, MSN, BC-FNP-C, CWOCN. "After many years of seeking out better methods to help patients gain more control in managing their colostomies, with Vitala™ CCD we now have a technology that provides the temporary continence they need and deserve."

The innovative Vitala™ CCD functions by sealing against the stoma to prevent the uncontrolled release of stool while permitting gasses to vent through an integrated, deodorizing filter. When in use, stool is stored inside the body, negating the need to wear an ostomy pouch. The unique design of Vitala™ CCD not only eliminates the need for a pouch for an extended period of time each day, it also minimizes the noise and odors that occasionally accompany pouch use. The discreet low profile device also helps make the presence of an ostomy less noticeable.

The multi-center Phase 2 clinical study evaluated the safety and efficacy of the device when worn up to 8 hours a day by individuals with an end colostomy. Participants in the study (n=25) were monitored across treatment stages: usual pouching (21 days), skin barrier transition (14 days), and device wear (107 days). Because Vitala™ CCD seals against the stoma, the study also evaluated stoma vascularity and microbiology.

After the study period of 142 days, results showed that there were no serious adverse events associated with wearing the device. Three participants reported adverse events that were considered related to device wear, none of which led to discontinuation from the study. Throughout the device wear stage, no changes to either stoma vascularity or gut microbiology were observed.(1)

Participants in the study reported high levels of satisfaction with the device and its performance, with 87 percent rating the ability to restore continence as good or very good at the end of the study period. Four out of five users (80 percent) reported no odor when wearing Vitala™ CCD and nearly three out of four (73.9 percent) reported less than usual stoma noise. At the end of the study period, approximately two-thirds (65.2 percent) of participants, who had used pouching systems on average for more than six years, stated that the Vitala™ device was their preferred method of ostomy management.(1)

"These promising Phase 2 results demonstrate the safety and efficacy of this novel approach to colostomy management, in providing temporary continence and alleviating colostomy-related concerns," added Maxwell. "After the initial adjustment and once routinely wearing Vitala™ CCD, many of our participants actually became aware once again of when the bowel would need to move and they could act accordingly, much as people without a colostomy do."

Vitala™ CCD is recommended for use after a minimum of 6 weeks after surgery. Full product use information is available in the package insert. Easy to apply and remove, the Vitala™ CCD contains a built-in expandable container to prevent soiling and odor during the removal process. Vitala™ CCD is also waterproof, so it can be worn when bathing, showering or swimming.

"ConvaTec developed this breakthrough technology to give people with a colostomy regained control, more confidence and greater freedom," said Marcus Schabacker, Chief Scientific Officer of ConvaTec. "As the authors conclude, Vitala™ CCD provides an important option for colostomy continence, which we believe should be considered a fundamental patient right, and we are committed to further demonstrating how this benefit can make a difference in people's lives."

For more information about the Vitala™ Continence Control Device, please contact the ConvaTec customer information center at 1-800-422-8811.

About ConvaTec

ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key focus areas – Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices – ConvaTec products support health care professionals from the hospital to the community health setting. For more information, please visit www.convatec.com.

Vitala is a trademark of ConvaTec Inc.

Natura is a registered trademark of ConvaTec Inc.

(1) Maxwell, TR et al. Safety and Efficacy of a Novel Continence Device in Colostomy Patients; Dis Colon Rectum. 2010 Oct;53(10):1422-31.