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ABSTRACT: Purpose
Injection with the bulking agent consisting of non-animal stabilized hyaluronic acid/dextranomer (NASHA(®)/Dx) is well tolerated and efficacious for the treatment of fecal incontinence (FI); however, the patient population that may derive maximum benefit has not been established. This post hoc responder analysis assessed demographic and baseline characteristics predictive of responsiveness to NASHA/Dx treatment.Methods
Adults with a Cleveland Clinic Florida fecal incontinence score (CCFIS) ≥10 were randomized to receive NASHA/Dx or sham treatment. The primary end point was response to treatment (ie, decrease from baseline of ≥50% in number of FI episodes) at 6 months; a prespecified secondary end point was change in fecal incontinence quality of life (FIQL) score at
SUBMITTER: Franklin H
PROVIDER: S-EPMC4780737 | biostudies-literature | 2016
REPOSITORIES: biostudies-literature