Development, usability, and randomized pilot feasibility study of a mobile application prototype supporting self-management of accidental bowel leakage.

Aims: Patients need support in managing conservative interventions for fecal incontinence (FI). To address this need, a three-phased study aimed to develop and test the usability of a mobile application prototype (App-p) supporting patient self-management of FI and examine the feasibility of conducting a randomized controlled pilot study of App-p use. Methods: Phase 1: The App-p was developed. Phase 2: App-p usability was tested. Phase 3: In a pilot feasibility study, patients with FI from an American continence/urogynecology practice were randomly assigned 1:1 to a usual care control group (UCC-Group) or usual care and App-p use group (APP-Group) and followed for five weeks. Study activities for both groups were completion of electronic data forms at baseline and five weeks and, at five weeks, a call with their clinician and an interview. Descriptive quantitative and qualitative analyses were conducted. Results: The I'M ABLe App-p described 11 conservative interventions for FI, each with a journal for self-reporting intervention performance. App-p usability was very good (System Usability Score = 72 (12.5) (mean (SD)). Twenty eligible participants were randomized as planned. All study activities were completed by 60 % (6/10) of the UCC-Group and 80 % (8/10) of the APP-Group. All journals were completed by 80 % (8/10) of the APP-Group versus 30 % (3/10) of the UCC-Group. The APP-Group accessed the App-p 27 (5-45) days (median (range)), describing it as easy-to-use, convenient, and increasing self-management accountability. One UCC-Group participant and two APP-Group participants withdrew. Conclusion: Results show feasibility of conducting a randomized controlled study using the App-p and support its further development.