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).