Real -World Evidence of the Long-Term Clinical Utility of a Vibrating Capsule in the Management of Chronic Idiopathic Constipation.

Abstract

Introduction: Pharmacological therapies for chronic idiopathic constipation (CIC) are useful, but many patients report dissatisfaction from a lack of efficacy and occurrence of adverse events. The vibrating capsule (VC) is an FDA approved non-pharmacologic, treatment for CIC. However, its long-term usefulness in a community setting is unknown. The goal of this study was to assess the long-term efficacy and safety of vibrating capsule treatment in a real-world community setting.

Methods: We conducted a post-marketing analysis of CIC patients prescribed VC who completed at least 3 or 6 months of treatment. The clinical utility was assessed via patient reported symptoms in an electronic stool diary. Safety data was also collected.

Results: 1722 patients were prescribed VC, and 491 and 298 took the VC and kept stool diaries for 3 and 6 months respectively. Approximately 46% of patients were >55 years of age and 85% were women. Compared to baseline, complete spontaneous bowel movement (CSBM) rates increased significantly throughout the 3 and 6 -month periods (average increase of >1 CSBM per week; P< 0.0001). Mean stool consistency (Bristol Stool Form Scale) improved from 2.9 (baseline) to 4.1 during treatment (P<0.0001), mean straining effort (1-4) decreased from 2.9 to 1.6 (P<0.0001), and toileting time also significantly decreased (P<0.0001). Safety analysis revealed that 4.6% of patients reported feeling a sensation of vibration, 1.8% reported abdominal pain and 0.64% reported diarrhea.

Conclusions: In a community setting, the VC appears both effective and safe for long term treatment of chronic constipation with diarrhea being notably uncommon.