Future developments and new technologies in the field of faecal incontinence: scanning the horizon using late-stage clinical trial registrations

Abstract

Aim The aim of this study was to examine how new technologies in late-stage clinical trials might address unmet patient, practitioner or caregiver need for faecal incontinence (FI) over the next 5 years. Methods Horizon scanning techniques were used to provide insights into the current landscape of emerging health technologies. A search was performed across clinical trial registries using the National Institute for Health Research Innovation Observatory’s ScanMedicine database (scanmedicine.com) to identify new, emerging interventions or health technologies (drugs, medical devices or diagnostics) that were addressing or investigating FI. Trials were then screened for relevance to FI in a non-blinded duplicate manner. Results 1163 records were identified through searching ScanMedicine, and 136 trials were included in the final data extraction and mapping process. The most frequently investigated FI intervention topics were complementary therapies (n=17, 12.4%); electrical stimulation (n=13, 9.5%); pelvic floor muscle training/biofeedback/sphincter exercises (n=13, 9.5%) and implanted sacral nerve stimulation (n=12, 8.7%). There was little evidence of new pharmaceutical technologies in development. Existing drugs are, however, being repurposed and trialled for the treatment of FI (eg, linaclotide, colesevelam). Such repurposed drugs often have lower development costs, shorter timelines and report lower failure rates compared with new pharmaceutical products. Conclusion Overall, the innovation space as indicated by late-stage clinical trials related to FI, is relatively stagnant. Patients, carers and healthcare professionals are demanding more effective treatment and containment options; however, these are unlikely to come to market in the immediate future.