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

@entity1 @entity1241 @entity322
BACKGROUND: Anal @entity322 is a common and multifactorial pathology that affects @entity1 ' 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 @entity322 and improving the @entity1 '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. @entity1 : Fifty-eight @entity1 were enrolled. Five @entity1 were lost to follow-up. Of the remaining 53 @entity1 , 41 (77.4%) were females. All @entity1 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 @entity1 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 @entity1 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 @entity1 sample is representative of only a limited portion of the population with @entity1241 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 @entity1 .
