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Updated: May 11, 2026

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

Satish S C Rao1, Yun Yan1, Shaheen Hamdy2

  • 1Division of Gastroenterology/Hepatology, Department of Internal Medicine, Augusta University, Augusta, Georgia.

Gastroenterology
|May 9, 2026
PubMed
Summary

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Translumbo-sacral neuromodulation therapy (TNT) significantly improved fecal incontinence (FI) and bowel symptoms in patients compared to sham treatment. This novel, non-invasive therapy demonstrated safety and efficacy in a randomized controlled trial.

Area of Science:

  • Neurology
  • Gastroenterology
  • Medical Devices

Background:

  • Fecal incontinence (FI) is a prevalent, multifactorial disorder with limited effective disease-modifying treatments.
  • Neuropathy is a key factor in FI, necessitating targeted therapeutic approaches.
  • Non-invasive neuromodulation offers a potential avenue for treating FI by addressing underlying neurological deficits.

Purpose of the Study:

  • To evaluate the efficacy and safety of translumbosacral neuromodulation therapy (TNT) in patients with fecal incontinence.
  • To compare the outcomes of two different dosages of TNT (2400 and 3600 pulses) against a sham treatment.
  • To assess the impact of TNT on FI episodes, bowel symptoms, quality of life, and anorectal function.

Main Methods:

  • A multicenter, double-blind, randomized sham-controlled trial was conducted.
Keywords:
Fecal IncontinenceNeurophysiologyTranslumbosacral Neuromodulation TherapyTreatment

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  • Patients with FI (≥1 leakage/week) received weekly TNT (1 Hz) with 2400 or 3600 magnetic stimulations, or sham, at 4 lumbosacral sites for six weeks.
  • Outcomes included a ≥50% decrease in weekly FI episodes, FI severity index (FISI), quality of life (FI-QOL), anorectal function, and neurophysiology, assessed via stool diaries and clinical evaluations.

    • Main Results:

    • Higher response rates were observed in the TNT groups (65.8% for 2400 pulses, 81.1% for 3600 pulses) compared to the sham group (32.4%).
    • Significant improvements in FISI scores and quality of life (FI-QOL) were noted in the TNT groups compared to sham and baseline.
    • TNT treatment led to improvements in nerve conduction latencies and anal squeeze pressures, with no serious adverse events reported.

    Conclusions:

    • Translumbosacral neuromodulation therapy (TNT) with 2400 and 3600 magnetic pulses is effective in improving fecal incontinence and associated bowel symptoms.
    • TNT demonstrates superior efficacy compared to sham treatment, offering a safe and well-tolerated therapeutic option.
    • The findings support TNT as a promising non-invasive treatment for fecal incontinence, particularly for patients with underlying neuropathy.