Data published in the March issue of the Annals of Surgery show that investigational use of sacral nerve stimulation with Medtronic InterStim® Therapy reduces faecal incontinent episodes and increases quality of life in patients with the condition. The 120-patient, multi-center study - the largest trial of its kind in the world and the first such trial in North America - examined the efficacy of InterStim Therapy in patients with chronic faecal 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 U.S. Food and Drug Administration (FDA).
“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 faecal incontinence”
"Fecal incontinence is a debilitating and distressing condition, and current treatment options are limited," said Steven Wexner, M.D., professor and chair, Department of Colorectal Surgery at Cleveland Clinic Florida, first author of the published manuscript and lead investigator of the clinical trial. "The results of this study are promising and may provide a new treatment option for patients with faecal incontinence." Dr. Wexner is a paid consultant assisting Medtronic in the development of educational materials relating to this therapy. He assumed this role after the clinical study was completed.
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 percent of patients experienced therapeutic success, defined as a greater than 50 percent reduction in the number of faecal incontinent episodes per week. Furthermore, perfect continence (100 percent improvement) was achieved in approximately 40 percent of the patients. Improvement remained stable over time, with 87 percent 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 Fe cal Incontinence Quality of Life (FIQOL) scale, a questionnaire composed of 29 questions, grouped into four domains: lifestyle, coping/behaviour, depression/self-perception and embarrassment.
"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 faecal incontinence," said Tom Tefft, president of the Neuromodulation business and senior vice president at Medtronic. "Medtronic has been the pioneer and long-time leader in neuromodulation technologies, including pursuing a high level of clinical evidence for our therapies. InterStim Therapy has been used to treat faecal 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."