Medtronic has reported that the data published in the March issue of the Annals of Surgery show that investigational use of sacral nerve stimulation with Medtronic InterStim Therapy reduces fecal incontinent episodes and increases quality of life in patients with the condition.
Medtronic said that the 120-patient, multi-center study is the first trial in North America that examined the efficacy of InterStim Therapy in patients with chronic fecal incontinence who had failed or were not candidates for more conservative treatments.
InterStim Therapy for bowel control in this patient population is currently under review by the FDA.
The study participants were implanted with a Medtronic InterStim system to deliver mild electrical stimulation to the sacral nerves that control the bladder, sphincter and pelvic floor muscles. At 12 months of follow-up, 83% of patients experienced therapeutic success, defined as a greater than 50% reduction in the number of fecal incontinent episodes per week.
According to Medtronic, perfect continence was achieved in approximately 40 % of the patients. Improvement remained stable over time, with 87 % therapeutic success rate in patients who had passed three years of therapy.
Additionally, patients receiving InterStim Therapy experienced an increase in overall quality of life at 12 months post-implant, as defined by the Fecal Incontinence Quality of Life (FIQOL) scale, a questionnaire composed of 29 questions, grouped into four domains: lifestyle, coping/behavior, depression/self-perception and embarrassment.
Tom Tefft, president of the Neuromodulation business and senior vice president at Medtronic, said: “InterStim Therapy has become an important treatment option for patients with overactive bladder who do not have success with more conservative therapies and a similar unmet clinical need exists for people living with fecal incontinence.
“InterStim Therapy has been used to treat fecal incontinence in Europe since 1994 and this clinical study shows InterStim Therapy has a significant impact on quality of life when few other treatment options exist.”
Steven Wexner, professor and chair of department of Colorectal Surgery at Cleveland Clinic Florida, first author of the published manuscript and lead investigator of the clinical trial, said: “Fecal incontinence is a debilitating and distressing condition, and current treatment options are limited. The results of this study are promising and may provide a new treatment option for patients with fecal incontinence.”