Updating Treatments for Fecal Incontinence VII
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]). NASHA/Dx FI is a biocompatible injectable bulking agent, and is the only bulking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of FI. Another recent FDA approved treatment is the ECLIPSE intravaginal system for fecal incontinence. There is also more recent data regarding the use of Imodium, patient education and biofeedback in the setting of a factorial design RCT.
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 (3 year data available). 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." In a new update, the AHRQ's guidance to clinicians and patients should reflect the current literature on this topic. In addition, if other bulking agents have not been recently studied or compared, the guidelines should reflect the bulking agents and other recent advancements such as the FDA approved ECLIPSE intravaginal system and data from RCTs of other treatments in current clinical use.
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 additional 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. This important, long term data.
- Franklin et al., 2016 Publication: Analyzed & highlighted the benefit of NASHA/Dx FI vs Sham in specific key patient subgroups.
From a personal communication with Palette, the company who owns the NASHA/Dx (Solesta), they shared the following:
- Post 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
A recent clinical trial that needs to be included is that of ECLIPSE
- Richter et al 2015 documented the effectiveness and safety of a vaginal bowel control (ECLIPSE trial), including efficacy and improvement of quality of life at 3 months
- Richter et al 2019 showed the 12 month clinical durability of effectiveness and safety of this device in decreasing fecal incontinence.
In additional a recent trial by the Pelvic Floor Disorders Network (CAPABLe trial), evaluated the effect of controlling anal incontinence by comparing anal exercises with biofeedback to loperamide (Jelovsek JE et al. 2019). These are all clinical trials that should be included in an updated AHRQ guideline on fecal incontinence.
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%. Rarely does single therapy result in cure for this condition, therefore the information on the latest advancements should be included.
(Optional) About You
What is your role or perspective? Professional medical society
If you are you making a suggestion on behalf of an organization, please state the name of the organization: American Urogynecologic Society
May we contact you if we have questions about your nomination? Yes
