Stool Diary App Aids Vibrating Capsule Compliance, Efficacy for Chronic Constipation

New research is shining light on the potential utility of a stool diary app for improving treatment compliance and certain constipation symptoms in patients with chronic idiopathic constipation (CIC) prescribed the vibrating capsule (Vibrant).

Findings from the post-marketing study were presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, last week by Satish Rao, MD, PhD, J. Harold Harrison Distinguished University Chair in Gastroenterology and director of the Clinical Research Center at Augusta University. These results showed patients who took the vibrating capsule and kept a daily electronic stool diary app had significantly greater first reorder rates and demonstrated significant improvements in key symptoms of constipation, suggesting the app may provide incremental benefit and facilitate treatment monitoring in CIC.

“In the last 2 decades, there have been at least 4 FDA-approved treatments for chronic constipation, but the major challenge we find in day-to-day practice is there is either a lack of efficacy or patients have intolerable side effects,” Rao explained to HCPLive. “That is a reason why almost half of the patients are not able to continue with treatment, and they are always searching for newer alternative therapies. There's a large unmet need for improving constipation therapies.”

Rao went on to describe how, ideally, treatment for CIC should work locally in the gut and be well-tolerated without creating any adverse effects, which was the basis for the creation of the vibrating capsule and its eventual US Food and Drug Administration approval in 2022.

In the study presented at ACG, patients were asked to use an app to record bowel symptoms, bowel movement (BM) frequency, complete spontaneous BM, stool consistency based on the Bristol Stool Scale, straining effort, and time spent on the toilet. Data from the first week of treatment were compared with changes during subsequent weeks while receiving treatment, and patients using the stool app were compared to those who did not.

During the study period, 1075 patients (82.5% female) received vibrating capsule treatment, of whom 453 (42%) downloaded the app and used the vibrating capsule for ≥ 1 week. Investigators noted proportionately more women than men and younger patients used the app but also pointed out 36% of patients ≥ 65 years of age also engaged with the app.

In total, 58 (12.8%) patients used the app for ≥ 8 weeks of treatment. Results showed patients who used the app were twice as likely to order a first refill compared to those who did not use it (68% vs 34%; P <.0001). Additionally, app users had a significant increase in the number of complete spontaneous BM/week, with a more than 2-fold increase in complete spontaneous BM rate (P <.0002). The mean stool consistency improved from 3.3 to 4.3, (P <.0001), the mean straining effort decreased significantly from 3.0 to 1.6 (P <.0001), and the time spent on the toilet decreased from 33 minutes per complete spontaneous BM to 15 minutes (P <.0001).

“For the first time, we have real-world experience data to show that by keeping an app, patients were able to track their bowel movements, and that tracking gave them feedback about their own performance which really helped them to continue the treatment,” Rao said, emphasizing the app’s positive impact on different aspects of bowel movements and prescription refills.

Editors’ note: Rao has relevant disclosures with Ironwood Pharmaceuticals and Pallette Life Sciences.

References

1. ^{Rao SSC, Brenner DM, Cash BD, et al. P4074 - How Valuable is an Electronic Stool Diary App in the Management of Chronic Idiopathic Constipation (CIC) When Using the Vibrating Capsule (VC). Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}
2. ^{Vibrant Gastro. FDA grants marketing authorization for Vibrant a new drug-free treatment for adults with chronic constipation. August 30, 2022. Accessed November 6, 2024. https://www.einnews.com/pr_news/588483585/fda-grants-marketing-authorization-for-vibrant-a-new-drug-free-treatment-for-adults-with-chronic-constipation}