Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper Versus SphinKeeper

. We aim to evaluate morphofunctional changes of the sphincter complex after GateKeeper (GK) and SphinKeeper (SK) procedures and correlate these with symptom improvement. . Ten consecutive females undergoing SK implant were age-matched with a cohort of 10 females who previously underwent the GK procedure. Patients in the SK and GK groups underwent implantation of 10 and 6 prostheses, respectively. Muscle tension (), expressed in millinewtons per centimetre squared, mN (cm), was calculated using the equation = ()(), where is the average maximum squeeze pressure and and the inner radius and thickness of the external anal sphincter, respectively. The pre- and postimplant changes in and Cleveland Clinic Fecal Incontinence Score (CCFIS) were tested by linear and Poisson regression models, respectively. . The CCFIS significantly improved in both groups at 12-month postimplantation. Although not reaching statistical significance, symptom improvement after SK was 33% above that observed after GK ( = .088). Compared to the baseline, a significant increase in was observed in both groups at 12 months (GK, 508.1 [478.8-568.0] vs 864.4 [827.0-885.8] mN (cm); SK, 528.0 [472.7-564.0] vs 858.6 [828.0-919.6] mN (cm), = .005). Compared to the GK group, was significantly higher in patients after SK implant (158.3 mN (cm) [95% confidence interval, 109.6-207.0]; < .001), after controlling for baseline values, at 12-month postimplantation. . GK and SK are safe and effective treatments for FI with good short-term clinical outcomes. Comparative analysis showed superiority of SK over GK in terms of gain in , with borderline significantly better improvement in symptoms. Larger studies are needed to confirm these findings.