The UNC School of Medicine is one of four clinical sites, funded by a new five-year, $10 million NIH grant, that will identify the most effective treatment options for patients with accidental bowel leakage (ABL), which is also known as fecal incontinence (FI). The study will compare biofeedback (BIO), sacral nerve stimulation (SNS), and injectable bulking agents (INJ), three treatments currently approved by the FDA, but not consistently reimbursed by insurance companies.
The study aims to compare the three treatments according to efficiency, safety and cost, with the hope of identifying which patients will benefit the most from a particular treatment.
ABL is a condition frequently associated with a social and economic burden, and if severe enough, can lead to premature admission to a skilled nursing facility. It’s estimated 9% of women and 8% of men in the general population have experienced FI in the past month and at least 3% of the population experiences FI weekly.
William E. Whitehead, PhD, professor of medicine in the department of medicine’s division of gastroenterology and adjunct professor of obstetrics and gynecology in the division of urology, is the primary principal investigator.
“Fecal incontinence is a very common condition, that can significantly impair quality of life. Many people keep this condition to themselves because it can be upsetting and embarrassing,” said Whitehead, Director of the UNC Center for Functional Gastrointestinal and Motility Disorders. “There are lots of ways to treat it [ABL] but we don’t know how well they work. If we can determine which patients respond the best, we can begin to develop guidelines for management.”
Secondary outcome measures will include identifying the physiological, clinical, and psychosocial predictors of who will respond to each treatment. In addition, the project will allow patients who do not respond to the initial randomly assigned treatment to select a second treatment after 3 months. It will also compare treatment combinations to see which appears best (uncontrolled), and the effects of an enhanced medical management program will be assessed on efficacy, safety, and cost. A successful outcome will guide treatment algorithms and reimbursement policies nationwide.
Co-investigators at UNC include Jennifer Wu, MD, MPH, from the department of obstetrics and gynecology, and Anne Peery, MD, MSCR, from the division of gastroenterology.
Other key personnel include Steven Heymen, PhD, Jan Busby-Whitehead, MD, Elizabeth Geller, MD, Nicole Chaumont, MD, Yolanda Scarlett, MD, Shifali Arora, MD, Maggie Wilkins, RN, MSN, WHNP-BC, Jessica Gage, and Stefanie Twist.
Principal investigators from other clinical sites include Adil Bharucha, MBBS, MD, from the Mayo Clinic, Satish Rao, MD, PhD, from the University of Augusta, in Georgia, Ann C. Lowry, MD, from the Colon and Rectal Surgery Associates in Minneapolis, and Marie Gantz, PhD, from Research Triangle International (RTI).