The FDA has issued Medtronic clearance to market the InterStim sacral nerve stimulation therapy system for people with chronic fecal incontinence. The pacemaker-like device has already been FDA cleared for urinary control and has shown an 80% success rate in improving bowel control in the latest study published in Annals of Surgery.
The implantable InterStim system uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. As a result, the therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients. InterStim Therapy is the only bowel control treatment option that allows patients and physicians to determine probable success of the therapy through a test stimulation procedure prior to committing to long-term therapy.
Data from the Medtronic-sponsored pivotal study that led to FDA approval show InterStim Therapy for Bowel Control reduced fecal incontinent episodes and increased quality of life in patients with the condition. The 120-patient, multi-center study – the largest trial of its kind in the world – examined the efficacy of InterStim Therapy in patients with chronic fecal incontinence who had failed or were not candidates for more conservative treatments. The results were published in the March 2010 issue of the Annals of Surgery.
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 fecal incontinent episodes per week. Furthermore, complete continence (no incontinent episodes) was achieved in more than 40 percent of the patients. In addition, patients in the study showed significant improvement in quality of life as measured by the Fecal Incontinence Quality of Life (FIQOL) Index.
In the study, the most common device or therapy-related adverse events that occurred during the implant phase included implant site pain (25.8 percent), paraesthesia – a sensation of tingling, pricking, or numbness of the skin (12.5 percent), and implant site infection (10.8 percent). The majority of the events were successfully handled by minimal interventions. No adverse device effects were unanticipated.
Press release: Medtronic Announces FDA Approval of Interstim® Therapy for Bowel Control…
Product page: InterStim Therapy…
Abstract in Annals of Surgery: Sacral Nerve Stimulation for Fecal Incontinence: Results of a 120-Patient Prospective Multicenter Study
Flashback: Sacral Nerve Stimulation to Treat Fecal Incontinence Shows Promise