Randomized Sham-Controlled Trial of Translumbosacral Neuromodulation Therapy for Fecal Incontinence.

BACKGROUND & AIMS: Fecal incontinence (FI) is a multifactorial disorder that lacks effective, disease-modifying treatments. We investigated the efficacy and safety of translumbosacral neuromodulation therapy (TNT), a novel noninvasive treatment targeting neuropathy, in a multicenter, double-blind, randomized sham-controlled trial.

METHODS

FI patients (≥1 leakage/wk) were randomized to receive TNT (1 Hz) with either 2400 or 3600 repetitive magnetic stimulations or sham stimulations at 4 lumbosacral sites, weekly for 6 weeks. Daily FI episodes and bowel symptoms were assessed with prospective stool diaries. Outcomes included a ≥50% decrease in weekly FI episodes (primary), FI Severity Index, quality of life, anorectal function, and neurophysiology.

RESULTS

Of 109 patients randomized, there were 25 of 38 (65.8%) responders in the 2400 group, 30 of 37 (81.1%) responders in the 3600 group, and 11 of 34 (32.4%) responders in the sham group (odds ratio (95% confidence interval) for 2400 vs sham: 3.91 (1.48-10.91); for 3600 vs sham: 8.53 (2.96-27.47); 3-way analysis of variance P ≤ .001). FI Severity Index scores improved significantly in the TNT groups compared with sham (P = .02). FI quality of life domains improved in TNT groups compared with baseline (P = .002) but not between groups and in sham group. Lumbo-anal, sacro-anal, lumbo-rectal, and sacro-rectal nerve conduction latencies (P < .04) and anal squeeze pressures (P < .05) improved in the TNT groups when compared with sham. No treatment-related serious adverse events were reported. Two patients in each group reported back pain, and 1 patient each in the 2400 and 3600 groups reported tingling and urinary urgency.

CONCLUSIONS

TNT treatments with 2400 and 3600 magnetic pulses showed superior efficacy in improving FI and bowel symptoms when compared with sham treatment and was safe and well tolerated. (Clinical Trials.gov: NCT03899181).