PURPOSE: Anal bulking agents are injected to pose a stronger obstacle to the involuntary passage of feces and gas. This prospective, multicenter study was designed to evaluate the safety and efficacy of Durasphere (R) anal injection for the treatment of fecal incontinence. PATIENTS AND METHODS: Thirty-three unselected patients with incontinence (24 females; mean age, 61.5 +/- 14 (range, 22-83) years) underwent anal bulking agent submucosal injection with carbon-coated microbeads (Durasphere(R)) in the outpatient regimen. The causes of incontinence were obstetric lesions in 18.2 percent, iatrogenic in 36.4 percent, rectal surgery in 12.1 percent, and idiopathic in 33.3 percent. Previous unsuccessful treatments for fecal incontinence included diet and drugs in 16 patients, biofeedback training in 7 patients, sacral nerve modulation in 6 patients, sphincteroplasty in 2 patients, artificial bowel sphincter in 1 patient, and PTQ macroplastique bulking agent in 1 patient. Under local anesthesia and antibiotic prophylaxis, a mean of 8.8 (range, 2-19) ml of Durasphere (R) were injected into the submucosa by using a 1.5-inch, angled, 18-gauge needle. RESULTS: After a median follow-up of 20.8 (range, 10-22) months, the median Cleveland Clinic continence score decreased significantly from 12 to 8 (P