Update to Treatments for Fecal Incontinence

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

I recommend that the AHRQ systematic review entitled "Treatments for Fecal Incontinence" (FI)(March 21, 2016) be updated to reflect the latest evidence about modalities, specifically including the latest evidence about perianal bulking with non-animal stabilized hyaluronic acid/dextranomer [NASHA/Dx FI]), abiocompatible 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 before more recent studies demonstrating the long-term efficacy, safety, and durability of NASHA/Dx FI were published. This new evidence warrants an update, because the 2016 document ends with the statement: "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. AHRQ's prior guidance was generalized to all bulking agents. However, 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?

Please consider all evidence of NASHA/Dx FI's safety and effectiveness, 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

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?

To educate physicians, patients, and third-party payers with respect to the current state of evidence in the treatment of fecal incontinence.

(Optional) About You

What is your role or perspective? Physician and researcher actively engaged in looking after patients, advocating for them, and doing clinical trials.

May we contact you if we have questions about your nomination? Yes

Title: Professor of Medicine