Comparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods.

ABSTRACT: Fecal incontinence (FI), the involuntary passage of stool, is common and can markedly impair the quality of life. Among patients who fail initial options (pads or protective devices, bowel modifying agents, and pelvic floor exercises), the options are pelvic floor biofeedback (BIO), perianal injection with bulking agents (INJ), and sacral nerve electrical stimulation (SNS), which have not been subjected to head-to-head comparisons. This study will compare the safety and efficacy of BIO and INJ for managing FI. The impact of these approaches on quality-of-life and psychological distress, cost effectiveness, and predictors of response to therapy will also be evaluated. Six centers in the United States will enroll approximately 285 patients with moderate to severe FI. Patients who have 4 or m

SUBMITTER: Bharucha AE 

PROVIDER: S-EPMC8429255 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature