Patients and study design

Details of the patient population, inclusion and exclusion criteria, and study design have been described previously.25 Briefly, patients 18 to 75 years of age with FI (Cleveland Clinic Florida fecal incontinence score [CCFIS] ≥10) and ≥4 episodes of FI during a 2-week time frame from the US and Europe were randomized (2:1) to receive transanal injections of NASHA/Dx or sham treatment. Immediately before receiving treatment, patients received a cleansing enema. Using an anoscope, four 1 mL injections were administered (1 mL in each quadrant [posterior, left lateral, anterior, and right lateral] of the submucosa of the anal canal), ~5 mm above the dentate line, without the use of anesthesia. The procedure for patients receiving sham treatment was similar, except that no substance was injected. At 1 month, patients with no persistent adverse events but persistent FI (CCFIS ≥10) were offered one retreatment procedure. Patients and study investigators were blinded to treatment administered during the first 6 months post-injection. During this 6-month period, patients underwent a clinical anorectal assessment and proctoscopy at 3 and 6 months.25 The study was approved by the ethics committees and institutional review boards of all participating centers. All patients provided signed, informed consent.