Comparative Effectiveness of Biofeedback vs Dextranomer-Hyaluronate Injection for Fecal Incontinence: A Randomized Clinical Trial
In brief
Biofeedback and anal injections cut episodes by 75% or more in about 28%
In adults whose fecal incontinence persisted despite medical and behavioral treatment, about 28% in each group achieved at least a 75% reduction in episodes after three months. Neither treatment proved superior, and injections cost payers and society about $1,600 more per patient; longer-term outcomes and whether results differ in other patients remain unknown.
- Journal
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Q1)
- Published
- 6 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Adil E Bharucha, Satish S C Rao, William E Whitehead, Isuzu Meyer, William D Chey, Marie G Gantz, et al.
- PMID
- 42838314
- DOI
- 10.1016/j.cgh.2026.09.040
Why clinicians should know about it
- Picked for Gastroenterology (top studies of the week, 25 October 2026): Neither biofeedback nor dextranomer superior for efficacy
Abstract
BACKGROUND AND AIMS: Anal dextranomer injection and anorectal biofeedback therapy have not been rigorously compared in patients with fecal incontinence (FI) that is refractory to medical and behavioral therapy (MBT). This study compared their effectiveness, safety, and costs. METHODS: The Fecal Incontinence Treatment (FIT) study was a clinical trial (ClinicalTrials.gov: NCT03811821) conducted at 5 US medical centers. Adults with MBT-unresponsive FI (≥4 episodes/2 weeks) were randomized to receive either injections or biofeedback. The 3 outcomes were a ≥75% reduction in FI episodes at 3 months vs baseline; the proportion of patients with pelvic pain (grade ≥II), treatment-site infection, or serious adverse events (AEs) requiring hospitalization within 3 months of randomization; and treatment cost. RESULTS: Of 8,705 screened participants, 275 began MBT and 267 completed it. Among MBT nonresponders, 200 patients (176 [88%] women, 34 [12%] men) were randomized to injections (n=101) or biofeedback (n=99). After 3 months, FI frequency decreased by ≥75% for similar proportions of each treatment arm (injection, n=28/101 [27.7%] vs biofeedback, n=29/99 [29.3%]; adjusted odds ratio, 0.9 [95% CI, 0.5-1.7]; P=.79). Seven participants (injection, n=5; biofeedback, n=2; P=.27) had 11 relevant AEs, of which 5 were serious, non-treatment-related AEs (injection, n=3; biofeedback, n=2). Compared with biofeedback, injections cost an average of $1,563 (95% CI, $1,477-$1,649) more per patient for payers (P<.001), $38 (95% CI, -$2 to $78) more for patients (P=.06), and $1,579 (95% CI, $1,464-$1,694) more for society (P<.001). CONCLUSIONS: In this superiority trial, neither biofeedback nor dextranomer was superior for the primary efficacy endpoint in patients with moderate-to-severe, MBT-refractory FI. Biofeedback is less expensive for payers and society.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.