Updating Treatments for Fecal Incontinence XI
1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?
I would like the AHRQ March 21, 2016 systematic review entitled "Treatments for Fecal Incontinence" (1) to be updated to include more recent clinical data on Solesta Injectable Gel, a biocompatible bulking agent approved by FDA for the treatment of fecal incontinence.
2. Why are you struggling with this issue?
Fecal incontinence affects up to 18% of the general population worldwide1. Causes of fecal incontinence include muscle damage, nerve damage, constipation, diarrhea, hemorrhoids, loss of storage capacity in the rectum, surgery, rectal prolapse, physical inactivity, childbirth by vaginal delivery and rectocele2. There is a significant unmet need for patients who suffer from fecal incontinence. Due to the shame and emotional toll of this condition, many people avoid seeking fecal incontinence treatment. Obviously, there is a great need for a safe and effective treatment.
The AHRQ March 21, 2016 systematic review entitled “Treatments for Fecal Incontinence” states, “We found limited evidence to support any FI treatments beyond 3 to 6 months.”3 However, clinical data for Solesta Injectable Gel, an FDA approved, non-surgical intervention for the treatment of fecal incontinence, is now available for 534 subjects enrolled in three multicenter studies conducted in the US, Canada and Europe. Solesta is administered in the doctor’s office through 4 injections into the wall of the anal canal. The injections improve the bulk and thickness of the anal walls, providing more control of bowel movements. Solesta is a gel composed of two naturally occurring sugars, dextranomer and hyaluronic acid (HA). The HA in Solesta has been used in more than 40 million procedures worldwide, often as a dermal filler for wrinkle correction.
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
The AHRQ March 21, 2016 systematic review entitled “Treatments for Fecal Incontinence” should be updated to include more recent clinical data on Solesta Injectable Gel. Clinical data supporting the safety and effectiveness of Solesta are now available from four clinical studies: 1) a pivotal, prospective, multicenter, randomized, sham-controlled double-blind study of 206 patients conducted under an Investigational Device Exemption, 2) a prospective, single-arm, multicenter, observational clinical study of 283 patients conducted under a Post Approval Study, 3) a prospective, multicenter, open-label study of 115 patients conducted outside the United States, and 4) a single center study of 34 patients conducted at one site in Sweden. The pivotal study demonstrates the safety and effectiveness of Solesta. The post approval study supports the findings of the pivotal study and demonstrates the continued safety and effectiveness of Solesta up to 36 months after the last Solesta injection. The other clinical studies provide supporting evidence of safety and effectiveness.
The most recently completed study enrolled and followed 283 subjects for 36 months after the last Solesta injection. The results from this study (expected to be published later this year) show the mean change from baseline in the Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) Score was -4.0 at 36 months after last Solesta treatment. Additionally, from baseline to 36-months after last Solesta treatment, the improvement in each domain of the FIQL (Lifestyle, Coping/Behavior, Depression/Self Perception and Embarrassment) and the reduction in symptoms burden based on the CCFIS scale were statistically significant. Furthermore, for CCFIS and each FIQL sub-scale, the mean change from baseline to 36-months post-treatment exceeds the minimal clinically important difference, and therefore, is considered to be clinically significant as well.
4. When do you need the evidence report?
5. What will you do with the evidence report?
The updated evidence report would educate patients, providers and payers on the availability of safe and effective fecal incontinence treatments, including Solesta, an FDA approved, nonsurgical treatment.
- Paquette IM, Varma MG, Kaiser AM, Steele SR, Rafferty JF. The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. 2015;58:623–636.
- Mayo Clinic. Fecal incontinence symptoms & causes. Available at http://mayoclinic.com. Accessed September 13, 2019.
- Treatments for Fecal Incontinence.
(Optional) About You
What is your role or perspective? Clinical Research Consultant
May we contact you if we have questions about your nomination? Yes
Title: Senior Project Manager