ConvaTec, a world-leading developer of innovative medical technologies for community and hospital care, today presented data supporting the safety and efficacy of Vitala™, a novel, non-intrusive pouchless ostomy device that provides temporary continence to people with a colostomy. The clinical trial data were presented at the 2010 Joint Conference of the Wound, Ostomy and Continence Nurses Society (WOCN) and World Council of Enterostomal Therapists (WCET), where the new device is being previewed to U.S. and global healthcare professionals.
The Vitala™ Continence Control Device (CCD) allows individuals to manage their colostomy without a pouch, belt or irrigation. Indicated for use up to 8 hours, Vitala™ CCD is a single-use, disposable disc which is worn together with the ConvaTec Natura® skin barrier (1-3/4" or 2-1/4"). Currently available in select European markets, Vitala™ CCD will be introduced in the U.S. this fall.
This innovative pouchless ostomy device functions by sealing against the stoma to prevent 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. After the study period of 142 days, results showed that there were no serious adverse events associated with wearing the device, and no changes to either stoma vascularity or gut microbiology were observed.
Additionally, Vitala™ CCD users in the study reported high levels of satisfaction with the device and its performance, with 87 percent of Vitala™ CCD users rating the ability to restore continence as good or very good. 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. During the final 3 weeks of the study, barrier leakage with Vitala™ CCD was reported as equivalent or comparable when compared to usual product.
"Incontinence, odor, leakage and the inability to control gas are key concerns for people with a colostomy, which can profoundly impact a person's life," said study investigator Terri Maxwell, RN, MSN, BC-FNP-C, CWOCN. "As the study shows, this transformative technology was able to restore continence for up to eight hours at a time, and holds tremendous promise that we may be able to significantly improve many patients' lives as a result."
Vitala™ is recommended for use after a minimum of 6 weeks after surgery. Full product use information will be available in the package insert. Easy to apply and remove, the Vitala™ Continence Control Device contains a built-in expandable container to prevent soiling and odor during the removal process. Vitala™ is also waterproof, so it can be worn when bathing, showering or swimming.
"As a leader in ostomy care for more than 30 years, 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. "The needs of people with an ostomy inspired us to create Vitala™ CCD, which is setting a new benchmark in ostomy management."
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