University of Michigan, Michigan Medicine Ann Arbor, Michigan
Introduction: Chronic idiopathic constipation (CIC) is a common and bothersome condition. Up to 40% of patients with CIC fail to improve with medical therapies and many are interested in non-pharmacologic options. A recent phase III trial found an orally ingested vibrating capsule (VC) (Vibrant, Yokneam, Israel) significantly improved key constipation symptoms including stool frequency, straining, consistency and quality of life in patients with CIC. The aim of this study was to determine the safety, tolerability and ease of use of the VC in patients with CIC
Methods: This was secondary outcome analysis of a prospective, randomized, multi-center, double –blind, placebo-controlled study in patients with CIC. Patients received either VC (2 distinct stimulation modes) or placebo capsule, once daily, five days a week for 8 weeks. Patients in the VC and placebo arms were taught how to activate the VC which included connecting to wi-fi, using a mobile app, and activating the capsule using a base station. A questionnaire evaluated the ease of use and functionality of the VC system.
Results: A total of 79 adverse events (AEs) were considered possibly related to the study treatments (44 in VC Mode 1, 9 VC mode 2, and 26 with placebo). (Table 1) No serious AEs (SAE) or treatment related diarrhea were reported in the VC. Two AEs in the placebo arm were considered severe (one transient ischemic attack and one with abdominal pain) but neither were considered related to the study treatment by the investigator. A vibrating sensation was reported by 11% in VC arm, but no subject withdrew because of this. Regarding functionality, 94% of patients found `Connecting the base unit to Wi-Fi’ – easy. 5% ranked it medium, 2% found it hard. Similarly, 97% of patients found `Setting up the base unit for use’ - easy. Also,82% found `Activating capsules’ - easy, 13% ranked it medium, 5% found it hard. Finally for the question, `Following the treatment for several months, once it is commercialized' - 85% reported that they would find it easy to use, 12% ranked it medium difficulty, and 3% ranked it hard.
Discussion: In this large phase III trial of patients with CIC, a VC was found to be safe and well tolerated. In particular no SAEs or diarrhea were observed. In addition, 82-94% of study participants found the VC system easy to use and 85% were willing to try this treatment if available.
