Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial

Background: Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. Aims: To investigate the optimal dose frequency, clinical effects and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. Methods: FI patients were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1 Hz, 5 Hz or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensori-motor function and quality of life (QOL) were compared. Primary outcome measure was change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. Results: Thirty-three FI patients participated. FI episodes decreased significantly (∆ ±95% CI, 4.2±2.8 (1 Hz); 2±1.7 (5 Hz); 3.4±2.5 (15 Hz); p<0.02) in all three groups when compared to baseline. The 1 Hz group showed a significantly higher (p<0.04) responder rate (91±9.1%) when compared to 5 Hz (36±18.2%) or 15 Hz (55±18.2%); no difference between 5 and 15 Hz (p=0.667). Anal neuropathy, squeeze pressure and rectal capacity improved significantly only in 1 Hz (p<0.05) compared to baseline but not in other groups. QOL domains improved significantly (p<0.05) with 1 and 5 Hz. No device related serious adverse events. Conclusions: TNT significantly improves FI symptoms in the short-term, and the 1 Hz frequency was overall better than 5 Hz and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and non-invasive treatment for FI.