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

By Convatec, PRNE
Monday, November 29, 2010

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

SKILLMAN, New Jersey, November 30, 2010 - Vitala(TM) 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(TM) 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(R) skin barrier, comes in two
sizes (45mm and 57mm) and 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(TM) CCD we now have a technology that provides
the temporary continence they need and deserve."

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

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 odour when wearing Vitala(TM) 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(TM) device was their preferred stoma care

"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(TM) 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(TM) 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(TM) CCD contains a built-in expandable
container to prevent soiling and odour during the removal process. Vitala(TM)
CCD is also waterproof, so it can be worn when bathing, showering or

"ConvaTec developed this breakthrough technology to give people with a
colostomy regained control, more confidence and greater freedom," said Marcus
, Chief Scientific Officer of ConvaTec. "As the authors conclude,
Vitala(TM) 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(TM) Continence Control Device,
please contact the ConvaTec customer information center at 0800-467-866.

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

Vitala is a trademark of ConvaTec Inc.

Natura is a registered trademark of ConvaTec Inc.

    (c) 2010 ConvaTec Inc.              AP-010497-MM [EM, AM]

(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.


    Punnie Donohue                      Kim Gorode
    ConvaTec                            Weber Shandwick
    +1-908-904-2151                     +1-212-445-8231

Punnie Donohue, ConvaTec, +1-908-904-2151, punnie.donohue at; or Kim Gorode, Weber Shandwick, +1-212-445-8231, kgorode at

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