Vitala™ Pouchless Continence Control Device Shown to be Safe and Effective for up to 12 Hours in Phase 3 Clinical Trial

SKILLMAN, New Jersey, September 28, 2011 /PRNewswire/ --

Restoration of continence rated as 'good' or 'very good' by 87% of users

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, deodourizing filter.  The unique design also helps reduce noise and odours, 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 centres 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 to wearing the device. No changes to stoma vascularity or gut microbiology were observed throughout the device wear stage.^[1]

The majority of participants in the study found Vitala™ CCD easy to apply (76%), remove (99%) and dispose of (100%). More than four out of five users (83%) reported less odour than their usual device and three out of five (60%) said they experienced no noise while wearing Vitala™ CCD. The device was also reported to be comfortable by 94% of participants and its profile acceptable by 77% of participants.  At the end of the study period, approximately 70% of participants, who had used traditional pouching systems on average for more than six years, stated that they preferred Vitala™ CCD to their usual pouching system.^[1]

"Vitala™ CCD was developed to give people with a colostomy regained control, more confidence and greater freedom, allowing them to feel much like they did before surgery," said Dheerendra Kommala, MD, Chief Medical Officer, ConvaTec. "In developing this novel technology, it was important to offer a high level of control with a device that is comfortable, safe, and able to manage noise and odour. The results of this clinical study provide further evidence that Vitala™ CCD truly represents a new era in stoma care."

Vitala™ is currently available in the Czech Republic, Netherlands and the United Kingdom with additional introductions scheduled for Austria and Denmark.  Vitala™ CCD is recommended for use a minimum of six weeks after surgery.  Full product use information is available in the package insert.  For more information about Vitala™ CCD, please contact the ConvaTec customer information centre.

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 healthcare professionals from the hospital to the community health setting. For more information, please visit http://www.convatec.com.

   
    Vitala is a trademark of ConvaTec Inc.
    (c) 2011 ConvaTec Inc.                         SC-000258-MM

[1] Durnal, A., Maxwell, T., Kiran, R.P. & Kommala, D. (2011) International study of a continence device with 12-hour wear times. British Journal of Nursing, 20(16), S28-S36.