Device innovator Medspira has announced a multi-center randomized clinical trial utilizing an investigational biofeedback device (based on the FDA cleared and currently marketed mcompass Anorectal Manometry system) combined with pelvic floor physical therapy for treatment of fecal incontinence.
Affecting every aspect of life, fecal incontinence is a common problem for between five and 12 million people in the U.S. annually. According to experts, reluctance to talk about the problem leaves many people unaware of the causes and treatments for the condition, negatively impacting quality-of-life. Sufferers experience social, sexual and other dysfunctions. Fewer than 10% of current sufferers are estimated to seek diagnosis and treatment for the problem.
Anorectal manometry evaluates bowel function in patients with constipation or fecal incontinence by measuring the pressure and strength of anal and rectal muscles. It involves a small, flexible catheter with sensors placed in the rectum, which is connected to a computer and recording device to capture results.
The newly announced study is expected to enroll 294 patients in the randomized trial. Each patient treated with manometry-assisted biofeedback and physical therapy will receive six sessions of the combined therapies over a 12-week period. Patient follow up will include anorectal manometry testing and quality-of-life indicator monitoring for six months.
“This study seeks to verify evidence from uncontrolled studies showing that manometry-assisted biofeedback in conjunction with physical therapy reduces fecal incontinence,” comments Jim Quackenbush, Medspira LLC CEO. “Our goal is to improve the quality-of-life for those who suffer from fecal incontinence by providing a low cost, easy-to-use system to treatment centers across the country.”
Source: Medspira, Inc., Business Wire