A Medical Device to Relieve Constipation

An oral capsule that vibrates as it moves through the digestive tract may become a unique nonpharmacological treatment for chronic constipation, according to a new study.

“This is the first time we have a medical device, not a chemical, to relieve the long-term concerns of patients with chronic constipation,” Yishai Ron, MD, lead researcher for the study and Director of Neurogastroenterology and Motility at Tel Aviv Sourasky Medical Center’s Department of Gastroenterology and Hepatology, told ConsultantLive.

“If it proves itself with similar results in more studies, it could be a potential revolutionary treatment to relieve constipation,” Dr Ron noted.

“Sometimes, drug therapies bring more issues than relief for these patients,” he continued. “The results of this study point to the potential for an alternative treatment that avoids the typical drug side effects, such as bloating and electrolyte imbalance, by imitating the body’s natural physiology.”

Dr Ron presented the results of a pilot study (abstract Sa2023 “Vibrating Capsule for the Treatment of Chronic Idiopathic Constipation (CIC) and Constipation Predominant Irritable Bowel Syndrome (C-IBS) – Safety and Efficacy”) at Digestive Disease Week 2014 in Chicago.

The study included 26 patients who took the capsule twice per week and responded to a daily bowel movement and laxative use questionnaire. All patients initially underwent a 2-week preliminary period without the use of laxatives.

In the study, the vibrating capsule was found to nearly double the weekly bowel movements of patients who had chronic idiopathic constipation and constipation-predominant irritable bowel syndrome.

Patients reported an increase in spontaneous bowel movements from 2 to 4 times per week, as well as a decrease in constipation symptoms, including reduced difficulty in passing stools and incomplete evacuation.

The study found minimal adverse effects from the capsule use, primarily abdominal pain, which was minor and self-limited. “We don’t know if this has to do with constipation or the capsule. We assume it is unrelated to the capsule,” Dr Ron said.

The capsule, which houses a small engine inside, is programmed to begin vibrating 6 to 8 hours after swallowing. The mechanical stimulations cause contractions in the intestine, which help move stool through the digestive tract, he said.

Chronic constipation is a highly prevalent disorder that affects about 15% of the US population. “Despite the widespread use of medication to treat constipation, nearly half of patients are unsatisfied with the treatment either because of side effects, safety concerns about long-term use, or the fact that it simply doesn’t work,” Dr Ron said.

Colleen Schmitt, MD, gastroenterologist in the Galen Medical Group in Chattanooga, Tennessee, and President-Elect of the American Society for Gastrointestinal Endoscopy, told ConsultantLive: “There are clearly unmet needs in our management of constipation from IBS. Research of this capsule among diverse patient populations and assessment of associated costs will help evaluate effectiveness. Theoretically, local, rather than systemic, therapies are an appealing idea.”

Dr Ron said he and his team are now recruiting 80 patients for a double-blind, multicenter, multinational trial. The patients will take the capsule over 2 months and will be monitored for 1 year or more.