Long-term Evaluation of Intrarectal Botulinum Toxin Injection Sessions for Treating Urge and Mixed Fecal Incontinence: Results from a Monocentric Historical Cohort

BACKGROUND: There is a lack of long-term data on the outcomes of intrarectal botulinum toxin injections as a new option therapy for urge fecal incontinence, particularly following reinjection sessions, reasons for treatment dropout, and safety data. OBJECTIVE: The objective of this study was to detail the outcomes of intrarectal botulinum toxin injections in our monocentric historical cohort with the longest known follow-up to date. DESIGN: This retrospective study included patients who underwent at least one intrarectal injection session of botulinum toxin administered during sigmoidoscopy. PATIENTS: We included patients who were being treated at our center for urge fecal incontinence with failure of first-line or second-line therapy. MAIN OUTCOME MEASURES: Treatment success after the injection sessions required patient satisfaction, with none to moderate symptoms and the absence of additional treatments (excluding medication). RESULTS: Seventy-nine patients were included (median age: 62.0 (51.0-69.0); 77/79 female gender) with a median follow-up of 37.0 (10.0 to 72.0) months. A total of 238 injection sessions were performed (median number of 1.0 (0.5-1.8) injection session by patient year of follow-up) with 76% efficacy after the first injection session. The median delay between reinjection sessions was 12.5 months (9.8 to 20.3). Twenty-nine patients experienced treatment failure (36.7%) during follow-up, mainly because symptoms did not improve significantly. A decrease from 11 (9.0 to 15.0) to 9.0 (5.0 to 12.0) was observed for the median Cleveland score. Eighty-eight nonserious adverse events, mainly constipation, were observed in 47 patients (59.5%). LIMITATIONS: As the present study was monocentric, the number of patients included was limited, albeit the patient cohort was larger than in most other published series. CONCLUSIONS: Intrarectal botulinum toxin injections for urge fecal incontinence seem to be efficacious in the long term. Further studies need to focus on injection methods and standardize follow-up and reinjection criteria. (See Video Abstract).