Middle-term outcomes of gatekeeper implantation for fecal incontinence

BACKGROUND: Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown. OBJECTIVE: The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper. DESIGN: This was a prospective clinical study. SETTINGS: The study was conducted at a large university tertiary care hospital. PATIENTS: Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures. INTERVENTIONS: All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation. MAIN OUTCOME MEASURES: The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively. RESULTS: Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term. LIMITATIONS: The study was limited by its small sample size and absence of quality-of-life data. CONCLUSIONS: Initial improvements after Gatekeeper implantation for fecal incontinence are sustained in the middle term. Accurate preoperative evaluation of coexistent clinical conditions that may negatively affect outcomes is recommended for patient selection.