Treatment of fecal incontinence - review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue.

Abstract

PURPOSE: Novel treatments are needed to augment medical therapy for fecal incontinence. METHODS: Medline and Google search (fecal incontinence and injection treatment), English publications. RESULTS: Twenty-two observational studies and 4 randomized controlled trials were identified. OS mostly with limited sample sizes reported promising results. Repeated injection was necessary in some patients. Effect on anal sphincter pressures was highly variable. Significant improvements in the length of anal high-pressure zone, asymmetry index and maximum tolerable rectal volume were suggested. Four randomized controlled trials (n=176) revealed: 1. Short-term benefits from injection of Bioplastique under ultrasound guidance compared with digital guidance; 2. Silicone biomaterial (PTQ) provided some advantages and was safer than carbon-coated beads (Durasphere); 3. PTQ did not demonstrate clinical benefit compared to control injection of saline; 4. There was significant improvement at 6 weeks post injection, but no difference between Bulkamid and Permacol. A 2010 Cochrane review, however, noted that these data were inconclusive due to limited number and methodological weaknesses. CONCLUSION: Further studies are warranted to assess patient-centered outcomes (e.g. adequate relief) in addition to the attenuation of severity of incontinence symptoms in ambulatory patients. In nursing home residents, cost-effectiveness studies combining injection treatment and prompted voiding (to mitigate constraints of immobility and dementia) in preventing peri-anal skin complications deserves to be considered.