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Clinical Trials

Dignity ProTect™
We believe the ProTect™ will soon be the preferred treatment for people suffering from fecal incontinence because it offers patients the ability to manage their condition discreetly and with dignity. Thanks to the ProTect™, they will once again be able to participate in normal activities without fear of an "accident."

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In April 2006, Dignity Products began a major clinical trial of the ProTect™. The trial was conducted in Italy through 10 different medical centers and involved approximately 50 patients.

The study, while completed, remains ongoing and is being directed by the Italian Society of Colorectal Surgery (SICCR) . The SICCR includes among its members several internationally well known colorectal surgeons. Each Center has a doctor who is overseeing the Trial, and the Patients at each Center are chosen by the doctor in charge, according to parameters included in the Research Protocol supplied to them by Dr. Paolo Giamundo, a Medical Consultant (Advisor) of Dignity Products. The goal of this trial is to determine if the ProTect™ can help patients successfully manage their fecal incontinence and produce an improvement in the quality of their lives.

Since fecal incontinence is caused by a variety of illnesses and injuries, this study will also be used to determine which types of patients can be helped most effectively by the ProTect™. This information can then be used by doctors to determine whether it is appropriate to prescribe the ProTect™ for a particular patient. As a secondary goal, the study may suggest variations of the ProTect™ that would be helpful to patients for whom the current version is not an appropriate choice of treatment.