TOPLINE: 

Translumbosacral neuromodulation therapy (TNT), a novel noninvasive outpatient treatment, was superior to sham treatment in improving fecal incontinence (FI) and restoring bowel control in patients with moderately severe FI who experienced an average of seven incontinent episodes per week. The treatment was overall safe and well tolerated.

METHODOLOGY:

• TNT delivers focal transcutaneous magnetic stimulation to the lumbosacral nerves that control anorectal function. A previous study found 1 Hz to be most effective for improving FI and neurophysiology, suggesting that the effects of TNT are mediated through neuroplasticity; however, it was not a sham‑controlled study, requiring further validation.
• Researchers conducted a phase 3, sham-controlled clinical trial at two academic centers in the US from June 2019 to April 2024 to evaluate the efficacy and safety of TNT in patients with FI.
• They enrolled 109 adult ambulatory patients (mean age, 64.1-65.5 years; 75.7%-85.3% women) with recurrent FI for 6 months who had not responded to dietary modifications, fiber supplementation, antidiarrheals, and Kegel exercises and who reported at least one weekly episode of solid or liquid FI on a 2-week prospective electronic stool diary. None of the participants had colonic mucosal disease.
• Participants were randomly assigned to receive TNT (1 Hz) with either 2400 or 3600 repetitive magnetic stimulations or sham stimulations, delivered transcutaneously to four lumbosacral sites once weekly for 6 weeks.
• The primary outcome was FI response, defined as at least a 50% reduction in FI episodes at the end of 6 weeks; secondary outcomes included changes in stool frequency and consistency, at least a 75% reduction in FI episodes, or no leakage.

TAKEAWAY:

• Participants receiving TNT with 3600 repetitive magnetic stimulation pulses and those receiving TNT with 2400 repetitive magnetic stimulation pulses were about 8.5 times (odds ratio [OR], 8.53; 95% CI, 2.96-27.47) and 3.9 times (OR, 3.91; 95% CI, 1.48-10.91) more likely to meet the study’s response criteria, respectively, than those receiving sham treatment.
• A greater proportion of patients receiving TNT than those receiving sham treatment achieved at least a 75% reduction in FI episodes. The weekly stool frequency and the percentage of FI episodes per week associated with urgency decreased significantly in the TNT groups.
• The FI quality-of-life scores showed meaningful improvement from baseline across all domains in the TNT groups; however, no meaningful improvement was observed in the sham group.
• Overall, TNT was well tolerated, with very few adverse events. Three serious adverse events were reported, but all were deemed unrelated to the treatment. Additionally, 75%-85% of participants recommended the treatment to others.

IN PRACTICE:

“TNT, a novel noninvasive outpatient-based treatment, was safe, well tolerated, and efficacious in improving FI symptoms, its severity, and lumbosacral neuropathy in patients with moderately severe FI,” the authors of the study wrote.

SOURCE:

The study was led by Satish S.C. Rao, MD, PhD, Augusta University, Augusta, Georgia. It was published online in Gastroenterology.

LIMITATIONS:

The study predominantly enrolled women. Researchers assessed outcomes over a short treatment period, and the longer-term durability of TNT is yet to be established. Although the 3600-pulse TNT group had more responders than the 2400-pulse group, the difference in the number of responders between the groups was not statistically significant, potentially reflecting limited study power.

DISCLOSURES:

The study was funded by a US Public Health Service Grant from the National Institutes of Health. One author disclosed holding a patent related to TNT. The remaining authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.