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Vitala™ Pouchless Continence Control Device Shown to be Safe and Effective for up to 12 Hours in Phase 3 Clinical Trial
Date:9/28/2011

SKILLMAN, N.J., Sept. 28, 2011 /PRNewswire/ -- Findings from an international Phase 3 clinical trial of the Vitala™ Continence Control Device (CCD) showed the device was safe and effective at restoring continence when worn up to 12 hours per day by people with a colostomy.  In addition, 87% of users rated the ability of the device to restore continence as "good" or "very good," according to the study results published in the British Journal of Nursing.(1)

Developed by ConvaTec, Vitala™ CCD is an innovative, non-invasive device that allows individuals to manage their colostomy without having to wear a pouch or incorporate irrigation. When in use, Vitala™ CCD prevents the uncontrolled release of stool, which is stored inside the body, while permitting gas to vent through an integrated, deodorizing filter.  The unique design also helps reduce noise and odors, and the discreet low profile device helps make the presence of an ostomy less noticeable.(1)

"For people with a colostomy, the loss of continence control gives rise to multiple concerns that can negatively impact their quality of life," said lead study investigator Ann Durnal, RN, BSN, CWOCN. "These findings, which are consistent with those of an earlier Phase 2 study, indicate that this transformational technology can achieve the goal of colostomy continence that has for so long eluded us."

The Phase 3 clinical study, conducted at 16 centers in the U.S. and Europe, evaluated the safety and efficacy of the device when worn up to 12 hours by individuals with an end colostomy for nearly six months.  Participants in the study (n=78) were monitored across a range of treatment stages, including usual pouching (21 days), skin barrier transition (14 days), and device wear (21 days of device ramp-up increasing to 12 hours of daily wear for 159 days).

After the study period of 215 days, results showed that there were no serious adverse events related
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SOURCE ConvaTec
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