Initial results of a new bulking agent for fecal incontinence: a multicenter study.

ABSTRACT

BACKGROUND: Anal incontinence is a common and multifactorial pathology that affects patients' lives and imposes considerable socioeconomic consequences. OBJECTIVE: The aim of this study is to evaluate the efficacy of a bulking agent, polyacrylate-polyalcohol (PP), in terms of diminishing the severity of incontinence and improving the patient's quality of life, assessing any adverse events. DESIGN: Data were obtained through a prospective, nonconsecutive, multicenter, noncomparative, postmarket study with a maximum expected follow-up of 3 years. Four investigational centers from Argentina and Brazil participated in this study. SETTINGS Injections of the bulking agent were administered in the operating room of tertiary hospitals. PATIENTS Fifty-eight patients were enrolled. Five patients were lost to follow-up. Of the remaining 53 patients, 41 (77.4%) were females. All patients scored between 6 and 12 on the Cleveland Clinic Florida-Fecal Incontinence Score as part of the inclusion criteria. INTERVENTIONS: The injection of the bulking agent (PP) was administered under intravenous sedation in the submucosa of the anal canal through the perianal skin to generate a bulk. MAIN OUTCOME MEASURES: The primary efficacy end point was the Cleveland Clinic Florida-Fecal Incontinence Score (or Jorge and Wexner index). The Rockwood-Fecal Incontinence Quality of Life index was also recorded. The treatment was considered successful if patients achieved a postoperative improvement of at least 50% on the Cleveland Clinic Florida-Fecal Incontinence Score. RESULTS: Successful treatment was met by 60.4% of the patients according to the last follow-up data. Quality-of-life indices showed consistently significant improvements. LIMITATIONS: Selection bias and the lack of a control group to evaluate the potential placebo effect of this novel bulking agent were limitations of this study. Because of the eligibility criteria, the resulting patient sample is representative of only a limited portion of the population with fecal incontinence at all 4 centers involved in this study. CONCLUSIONS: The injection technique was easy to perform, safe, and ideal for use as an outpatient procedure. This bulking agent (PP) significantly improved continence and quality of life in selected patients.