Randomized Sham-Controlled Trial of Translumbosacral Neuromodulation Therapy for Fecal Incontinence.
GastroenterologyMay 7, 2026 (epub)
Satish S C Rao, Yun Yan, Shaheen Hamdy et al.
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In 30 seconds
This multicenter, double-blind, randomized sham-controlled trial evaluated the efficacy and safety of translumbosacral neuromodulation therapy (TNT) in patients with fecal incontinence (FI). Among 109 patients, 81.1% in the 3600 pulse group and 65.8% in the 2400 pulse group experienced a ≥50% reduction in weekly FI episodes, compared to 32.4% in the sham group (P ≤ .001).
Key findings
- 81.1% of patients in the 3600 pulse group were responders compared to 32.4% in the sham group.
- 65.8% of patients in the 2400 pulse group were responders compared to 32.4% in the sham group.
- FI Severity Index scores improved significantly in the TNT groups compared to sham (P = .02).
- No serious treatment-related adverse events were reported.
Why it matters
Fecal incontinence is a challenging condition with limited treatment options. This study demonstrates that translumbosacral neuromodulation therapy may provide a safe and effective noninvasive treatment alternative for improving symptoms and quality of life in affected patients.