Comparative Effectiveness of Biofeedback vs Dextranomer-Hyaluronate Injection for Fecal Incontinence: A Randomized Clinical Trial.

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.