Pelvalon, manufacturer of the recently FDA-cleared Eclipse System, today announced the presentation of a new clinical analysis of the LIFE study.
The study, previously published in Obstetrics & Gynecology, was the pivotal trial of this first-of-its-kind treatment for women experiencing loss of bowel control that was the basis for the recent FDA clearance of the device.
This new analysis examined the symptoms that often occur when bowel control is lost: urgent bowel movements, loose stool, frequent bowel movements, and incomplete evacuation.
Madhulika G. Varma, M.D., professor and chief of Colorectal Surgery in the department of Surgery at University of California-San Francisco Medical Center, presented the results last week at the 2015 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Boston, Mass.
The analysis focused on symptoms that occur with loss of bowel control. Women with fecal incontinence who were fitted with an Eclipse insert in the study recorded information about every bowel movement, continent and accidents, in a diary. The following results were reported among the 61 women studied, based on one month of insert wear:
Stool frequency: 67% of patients who experienced an average of two or more bowel movements per day reported a statistically significant reduction in frequency of bowel movements
Bowel urgency: a 34-point reduction in patients reporting urgency after one month (73% reported urgency at baseline, compared to 39% reporting urgency at one month, p=0.0005)
Stool consistency: 32-point reduction in number of patients reporting liquid stool (64% of patients at baseline, and 31% at one month, p=0.001)
Complete evacuation, including a 19-point reduction in number of patients reporting incomplete evacuation (55% of patients at baseline, and 36% at one month, p=0.057)
"These symptoms, which are common for women suffering from loss of bowel control, are devastating for patients," said Dr. Varma.
As previously reported, the LIFE study demonstrated the safety and effectiveness of Eclipse in 61 women, with high efficacy (79%), an outstanding safety profile with no serious device-related adverse events, and significant improvements in quality of life, with 98% of patients saying they would recommend the system to a friend.