Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
Comparative Effectiveness of Biofeedback vs Dextranomer-Hyaluronate Injection for Fecal Incontinence: A Randomized Clinical Trial.
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Bharucha Adil E, Rao Satish S C, Whitehead William E, Meyer Isuzu, Chey William D, Gantz Marie G, Richter Holly E, Chua Heidi K, Heymen Steven, Lu Thanh T, Menees Stacy B, Perry William R G, Sridhar Amaanti, Szarka Lawrence A, Busby-Whitehead Jan, Hamilton Frank A
Аннотация
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.
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.