Update to Treatments for Fecal Incontinence II

Update to Treatments for Fecal Incontinence II

1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?

We recommend that AHRQ update its March 21, 2016 systematic review entitled "Treatments for Fecal Incontinence" (FI) to reflect the latest evidence about treatment modalities, specifically including the latest evidence about perianal bulking with non-animal stabilized hyaluronic acid/dextranomer [NASHA/Dx FI]), a biocompatible injectable bulking agent, which is the only bulking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of FI.

2. Why are you struggling with this issue?

AHRQ's 2016 review was issued prior to availability of more recent studies demonstrating the long-term efficacy, safety, and durability of NASHA/Dx FI. This new evidence warrants an update, as the 2016 document ends with the words: "future studies with higher quality could change the conclusions of this review." Moreover, other bulking agents have not been studied to this degree or achieved approval by FDA for this indication, so we struggle with AHRQ's prior guidance generalized to all bulking agents, as they are not comparable

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

We would like to see all evidence of NASHA/Dx FI's safety and effectiveness considered, including:

  • Mellgren et al., 2014 Publication: Reports long-term efficacy of Solesta® at 12 and 36 months, yet was not included among the sources cited for AHRQ’s 2016 guideline.
  • Franklin et al., 2016 Publication: Analyzed & highlighted the benefit of NASHA/Dx FI vs Sham in specific key patient subgroups.
  • NASHA/Dx FIPost Approval Study (PAS), 2020: 283-patient, 36-month, multi-center PAS with robust long-term outcomes data (recently accepted by FDA & publication pending) demonstrates:
    • Real-world safety, efficacy, and medical appropriateness of NASHA/Dx FI
    • Significant improvements in objective clinical measures, re-intervention rate (>80% of patients treated do not require re-intervention through 36-months post treatment), and durability
    • Sustained statistically & clinically significant improvement in the CCFIS and FIQL scales

Also, we believe this evidence warrants a recommendation for NASHA/Dx FI that is separate and distinct from that for other bulking agents, as none of the other approved by FDA for this indication and none have produced evidence of sustained safety and effectiveness in real-world use.

4. When do you need the evidence report?

Monday, March 15, 2021

5. What will you do with the evidence report?

We will use the updated guideline primarily to educate physicians, patients, and third-party payers with respect to the current state of evidence in the treatment of fecal incontinence, which affects up to 8.3% of non-institutionalized adults, drives over $11B in annual healthcare spending, and increases the likelihood of referral to a nursing home by 10–15%.

(Optional) About You

What is your role or perspective? Physician

If you are you making a suggestion on behalf of an organization, please state the name of the organization: Ohio

May we contact you if we have questions about your nomination? No

Title: Staff Surgeon

Page last reviewed March 2021
Page originally created July 2020

Internet Citation: Update to Treatments for Fecal Incontinence II. Content last reviewed March 2021. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.

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