Intrarectal Injections of Botulinum Toxin for the Treatment of Urge Fecal Incontinence: Long-Term Results of an FI-Toxin Cohort Study.

[BACKGROUND] The efficacy and safety of intrarectal botulinum toxin A (BoNT/A) injections in patients with urge fecal incontinence (FI) were evidenced in a large, multicenter, randomized, placebo-controlled study (FI-TOXIN). The aims of the present study were to evaluate the long-term efficacy and safety of intrarectal BoNT/A injections in a real-world setting in patients who participated in the FI-TOXIN study.

[METHODS] Data collected from patients who had previously participated in the FI-TOXIN study in 8 French centers from November 2015 to November 2020 were retrospectively analyzed. Given the transient effect of BoNT/A, patients who had received the first injection in the FI-TOXIN study could be re-injected if symptoms recurred. Information on re-injections, satisfaction of patients, severity of FI symptoms, adverse effects, and the switch to another treatment was retrospectively collected from medical charts between M6 (end of the double-blind phase) and M54 of the inclusion in the FI-TOXIN study.

[KEY RESULTS] Of the 191 patients in the initial FI-TOXIN cohort, 147 (77.0%) were included at M6. Between M6 and M54, 114 of these patients received 233 injections (68 first injections, 165 re-injections). Satisfaction information was available for 70 patients, of whom 43/70 (61.4%) were satisfied with all their injections. The treatment failed in 52/147 (35.4%) of the patients, with rejections of the treatment by patients due to insufficient perceived efficacy (34 patients), adverse effects or poor tolerance (11 patients), or switch to a surgical treatment (23 patients). Nonsevere adverse events were recorded after 45/233 (19.3%) injections. The two severe adverse events (cervical cancer and psychiatric hospitalization) were unrelated to the treatment.

[CONCLUSIONS] Intrarectal injections of BoNT/A displayed moderate long-term efficacy without major adverse effects.