Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.

ABSTRACT:

Objectives

Many fecal incontinence (FI) studies define primary efficacy outcome as a decrease from baseline of ≥50% in the number of FI episodes; this threshold has never been validated. We aimed to establish the validity and responsiveness of ≥50% reduction in FI episodes (responder50) as the threshold indicative of clinically meaningful response.

Methods

Adults with a Cleveland Clinic Florida fecal incontinence score ≥10 were randomized to receive nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection or sham treatment in a 6-month trial. Validity and responsiveness of the primary end point were evaluated post hoc. The data were compared using different thresholds for defining a responder for a number of end points.

Results

Data from 206 patients (NAS

SUBMITTER: Sanchez JE 

PROVIDER: S-EPMC4418408 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature