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

Jaime E Sanchez1, Darren M Brenner2, Howard Franklin3

  • 1Division of Colon and Rectal Surgery, University of South Florida Morsani College of Medicine, Tampa, Florida, USA.

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|January 16, 2015
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Summary

The ≥50% reduction in fecal incontinence (FI) episodes is a valid and responsive measure for clinical trials. This threshold effectively identifies meaningful treatment response in patients with FI.

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Area of Science:

  • Gastroenterology
  • Clinical Trials
  • Medical Device Research

Background:

  • The standard efficacy outcome in fecal incontinence (FI) studies, a ≥50% reduction in FI episodes, lacks validation.
  • Establishing a validated threshold is crucial for accurately assessing treatment effectiveness.

Purpose of the Study:

  • To validate the ≥50% reduction in fecal incontinence (FI) episodes (responder50) as a clinically meaningful response threshold.
  • To assess the responsiveness and validity of the responder50 threshold in FI treatment studies.

Main Methods:

  • A randomized trial comparing nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection to sham treatment in adults with FI (Cleveland Clinic Florida score ≥10).
  • Post hoc analysis evaluated the validity and responsiveness of different response thresholds for primary and secondary endpoints.

Main Results:

  • The responder50 threshold demonstrated convergent validity, correlating strongly with FI episode counts and FI-free days.
  • Treatment differences remained significant up to an 80% response threshold.
  • Patients achieving responder50 status showed significantly better outcomes on secondary efficacy endpoints, irrespective of treatment.

Conclusions:

  • The ≥50% response threshold is a responsive, valid, and clinically applicable measure for evaluating treatments in fecal incontinence (FI) studies.
  • This finding supports the continued use of the responder50 threshold in clinical research for FI.