Treatments for Fecal Incontinence Trial
1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?
We are conducting a multisite study to compare the effectiveness, safety, and cost of three approved treatments for severe fecal incontinence. The grant is U01 DK115575 and is described on ClinicalTrials.gov. Adult patients with fecal incontinence that occurs at least two times per week and does not respond to conservative measures (education, normalization of bowel habits with medications and fiber, and training in pelvic floor exercises for one month) will be randomized to one of these three treatments. The three treatments are biofeedback, sacral nerve electrical stimulation, or injections of dextranomer gel into the anal canal. Follow-up assessment will be at 3 months after beginning this treatment. Patients will be followed for two years. Non-responders to treatment may select a second treatment in our study.
A difficulty we have with this trial is that there is little information available about the safety and effectiveness of dextranomer injections for the treatment of fecal incontinence, and there is little information available on side-effects. However, there is one controlled trial [Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, and Bernstein M. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised sham-controlled trial. Lancet 2011;377:997-1003] which suggests efficacy, with only modest adverse events. There may be other reports on this treatment. A definitive review and a new study of the safety and efficacy of dextranomer injection would be extremely helpful in reassuring physicians who may want to refer patients to our study or who may consider this treatment for their patients.
2. Why are you struggling with this issue?
As noted above, there is very little published data out on the safety and efficacy of dextranomer injection. Not all of the available evidence is known to providers.
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
As an initial step, I would like to see one or more definitive reviews of the evidence of dextranomer or other bulking agents for the treatment of fecal incontinence. These should be reviewed by experts in the field and disseminated through a major clinical journal. A second step would be the funding of one or more controlled studies to assess the safety and efficacy of dextranomer injection. This study should assess the migration of the dextranomer injection at 6 months and 12 months. Evidence that this has occurred will be publication of the review and a change in the frequency of using dextranomer injections to treat bowel incontinence.
4. When do you need the evidence report?
Tuesday, December 1, 2020
5. What will you do with the evidence report?
If an evidence-based review is available, we will use it to inform physicians with patients who have fecal incontinence when we ask them to refer into our study. We will also include this review in publications and courses on the treatment of fecal incontinence, and will cite it in reviews that we may do on the management of this disorder.
(Optional) About You
What is your role or perspective? Principal investigator of a study
If you are you making a suggestion on behalf of an organization, please state the name of the organization: No organization.
May we contact you if we have questions about your nomination? Yes
Title: Professor of Medicine and Obstetrics and Gynecology
