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FDA Approves Marketing of Medical Device for Treatment of Abdominal Pain in Adolescents with IBS

The US FDA (United States Food and Drug Administration) approved the marketing of the IB-Stim medical device for the treatment of abdominal pain in adolescents with IBS.

What is the medical device for abdominal pain treatment?

The IB-Stim is a single-use electrical nerve stimulator that provides mild stimulation to specific nerves. The device is battery powered and is placed behind the ear for up to five days. After five days, the device is removed, however, new single-use IB-Stim devices can be replaced in the original’s place for up to three total weeks of treatment. In particular, the device is designed to be used by individuals between the ages of 11 and 18, and alongside other IBS-related treatment options.

How does it work?

The IB-Stim mildly stimulates certain cranial nerve branches around the ear, which is thought to help with the functional pain that is related to IBS. The IB-Stim is not indicated for use in adolescents who also have hemophilia, cardiac pacemakers, or a condition called psoriasis vulgaris. The FDA approved the IB-Stim through a special review pathway designed for new, low- to moderate-risk medical devices. Similar devices have been designed and used in acupuncture and the treatment of opioid addiction.

Is the treatment effective?

The FDA based its approval of the IB-Stim off of results from a clinical trial. The study included 50 individuals between the ages of 11 and 18 with IBS, who also had IBS-related abdominal pain. Of these 50 individuals, 27 were treated with the IB-Stim, and the other 23 were treated with a placebo device (a non-active treatment). The study looked at changes in Pain Frequency Severity Duration (PFSD) scores, usual pain, and worst abdominal pain over three weeks. All participants had similar severities of worst abdominal pain before starting the trial and were allowed to continue stable doses of medications for their abdominal pain, regardless of whether or not they were treated with the IB-Stim. The study did not investigate changes in bowel movements.

Overall, results from the trial showed a greater improvement in worst abdominal pain for those treated with the IB-Stim from the start of the trial across weeks one, two, and three when compared to those who were not treated with the IB-Stim. Nearly 60% of individuals treated with the IB-Stim had a 30% reduction in worst abdominal pain experienced, while only about 25% of those given placebo reached this point. The PFSD scores were also more improved for those treated with the IB-Stim when compared to the placebo group at the three-week mark. Additionally, over half of those treated with the IB-Stim had a 30% reduction in their usual pain, while less than a third of placebo patients experienced this outcome. Overall, the IB-Stim (alongside other IBS treatment options) seemed to lead to greater improvements in all pain categories studied by the researchers.

What are the side effects?

The most common adverse effects reported during the study were mild ear discomfort (six participants) and adhesive allergy at the side of the device application (three participants). The device is marketed by Innovative Health Solutions. The IB-Stim is available by prescription only.1

  1. FDA Permits Marketing of First Medical Device for Relief of Pain Associated with Irritable Bowel Syndrome in Patients 11-18 Years of Age. United States Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-medical-device-relief-pain-associated-irritable-bowel-syndrome-patients. Published June 7, 2019. Accessed June 11, 2019.

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