Injectable silicone biomaterial (PTQTM) is more effective than carbon‐coated beads (Durasphere®) in treating passive faecal incontinence – a randomized trial

Objective  Both injectable silicone biomaterial (PTQTM) and pyrolytic carbon-coated beads (Durasphere®) have been shown to be effective in treating passive faecal incontinence due to internal sphincter dysfunction. This is a randomized study to evaluate their relative safety and efficacy. Method  Forty patients (mean age 59.5 years vs 58.9 years) were randomized to have inter-sphincteric injection of PTQTM or submucosal injection of Durasphere®. Patients were assessed with anorectal physiology, endoanal ultrasound, a validated incontinence score and quality of life questionnaires. Results  In the Durasphere® group, complications included rectal pain (5%), erosion through rectal mucosa (10%), and type III hypersensitivity reaction (5%). No complications occurred in the PTQTM group. Compared with PTQTM, Durasphere® group has a more rapid action, with improved continence at 2 weeks after injection. In both groups, faecal continence significantly improved 6 weeks after injection, and continued to improve significantly up to 6 months in both groups (P < 0.0001). At 6 weeks, 6 and 12 months after injection, significantly more PTQTM patients achieved greater than 50% improvement in Wexner’s continence score than Durasphere® patients (respectively, P = 0.01; P < 0.0001; P = 0.001). There was a significant improvement in faecal incontinence quality of life scale and the 12-month physical health scale of Short Form-12 health survey in the PTQTM group but not in the Durasphere® group. Conclusion  In patients with internal sphincter dysfunction, injectable silicone biomaterial was safer and more effective than Durasphere®.