Updating Treatments for Fecal Incontinence VIII
1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?
It is 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]).
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. There have been 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:
- 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, it is believe that this evidence warrants a recommendation for NASHA/DxFI 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?
Wednesday, March 31, 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, and increases the likelihood of referral to a nursing home by 10-15%.
(Optional) About You
What is your role or perspective? Patient Advocate
May we contact you if we have questions about your nomination? No
