SAN DIEGO—Translumbosacral neuromodulation therapy, a noninvasive treatment using magnetic stimulation, reduced fecal incontinence episodes by 50%, with higher response rates observed with stronger levels of stimulation, in a study presented at DDW 2025.

Fecal incontinence (FI) is a complex condition that often involves lumbosacral anorectal neuropathy, and existing treatments have had limited efficacy because they do not address this pathophysiology (Am J Gastroenterol 2021;16[1]:162-170). Earlier studies have provided evidence of TNT’s short-term benefit on FI (Am J Gastroenterol 2021;16[1]:162-170; Neuromodulation 2021;24[7]:1269-1277), but its efficacy and safety were largely unknown.

The new study, a multicenter, randomized, sham-controlled trial of FI patients, presented at the meeting by Satish Rao, MD, PhD, a professor of medicine at Augusta University, in Georgia, lends support to the use of TNT in this setting. During an initial screening period, Dr. Rao and his co-investigators enrolled 802 patients with FI, asking them to document the frequency and severity of their FI for two weeks using an electronic stool diary. Approximately 648 patients were found to be ineligible and 47 were lost to follow-up, so the investigators randomized a pool of 109 patients into three equal groups: 2,400- and 3,600-stimulation TNT groups and a sham treatment group. TNT stimulations were administered at two lumbar and two sacral sites bilaterally, with 600 to 900 stimulations administered per site. The majority of the patients in all three cohorts were female (=76%) and white (=62%); the average age in the three groups was between 64 and 65 years. All the patients experienced FI at least once per week.

In the intention-to-treat analysis, the researchers found that the 3,600-stimulation group had the highest response rate, with 30 of 37 patients (81.1%) in this group achieving the primary end point of a 50% reduction in FI episodes, compared with 25 of 38 (65.8%) in the 2,400-stimulation group and 11 of 34 patients (32.4%) in the sham group (P<0.001).

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In addition, they found the secondary outcome of the Fecal Incontinence Severity Index—a composite of leakage composition, frequency and amount, as well as urgency and leakage without warning—significantly improved in both treatment groups compared with the placebo group (P=0.0195).

Although the resting sphincter pressure didn’t significantly change in either of the TNT groups, maximal and sustained squeeze pressure significantly increased in both groups. Sustained squeeze pressure increased from 65±22 to 89±26 mm Hg in the 2,400-stimulation group and 76±42 to 89±42 mm Hg in the 3,600-stimulation group.

The team also recorded improvements in anal neuropathy, as measured by motor-evoked potential latency in the left and right sacral anal areas (P=0.0067 and P=0.0063, respectively), and in quality-of-life measurements in the TNT groups.

Explaining that the stimulation feels “like a vibration,” Dr. Rao said all the study participants “tolerated the stimulation, and there was no long-term feeling [from the treatment] for the rest of the day,” and no significant treatment-related adverse effects.

The findings show that “TNT is a novel, noninvasive outpatient treatment that is safe and well tolerated in patients,” Dr. Rao said.

Acknowledging that one of the weaknesses of the study is that patients with spinal cord injuries and neurologic diseases were not included, he said one of the next steps may be looking into ways to make this a home-based treatment, but designers would have to retool to make the magnetic technology much smaller and more focused.

Elena Stoffel, MD, MPH, a clinical professor of internal medicine at the University of Michigan, in Ann Arbor, said the results of Dr. Rao’s work were “dramatic” for a condition for which there are few good treatment options. “This study demonstrated a really robust response, and a dose response, which further emphasizes the potential benefit.”

Dr. Stoffel said that although the magnetic equipment used in TNT is not available in most practices right now, if it were adapted, this approach could become widely available to the average FI patient. A device or belt to treat patients in an outpatient clinic or endoscopy unit or at home would be very beneficial to patients, she said.

“FI has such a detrimental impact on quality of life that if we can actually have a treatment that’s safe and effective, it could be really life-changing for our patients.”

—Karen Fischer

Drs. Rao and Stoffel reported no relevant financial disclosures.

This article is from the June 2025 print issue.