Carbon-coated microbeads anal injection in outpatient treatment of minor fecal incontinence

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<0.001) and the median American Medical System score from 89 to 73 (P=0.0074), but the Fecal Incontinence Quality of Life did not change significantly (74 to 76, P = not significant). Anal manometry significantly improved (resting pressure increasing from 34 to 42 mmHg; P=0.008) and squeezing pressure from 66 to 79 mmHg (P=0.04). Two patients complained of moderate anal pain for a few days after the implant, one patient had asymptomatic leakage of the injected material through a mucosa perforation, and two had distal migration of the Durasphere (R) along the dentate line. CONCLUSIONS: Anal bulking agent injection is a safe treatment and can mitigate the severity of fecal incontinence by increasing anal pressure but does not significantly improve the quality of life.