Trial reportNeuromodulation : journal of the International Neuromodulation Society2021
Effects of Translumbosacral Neuromodulation Therapy on Gut and Brain Interactions and Anorectal Neuropathy in Fecal Incontinence: A Randomized Study.
Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07192328 (Randomized Cross-Over Dose-Efficacy Study of rTMS in Healthy Young Female Volunteers), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Cross-Over Dose-Efficacy Study of rTMS in Healthy Young Female Volunteers
Who cites it
3 citing papers in PubMed.
- Controversies in fecal incontinence.World journal of gastroenterology · 2025Article
- Electroceuticals and Magnetoceuticals in Gastroenterology.Biomolecules · 2024Review
- Organizing and Developing a GI Motility Lab in Community Practice: Challenges and Rewards.Current gastroenterology reports · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectivesTranslumbosacral neuromodulation therapy (TNT) improves symptoms of fecal incontinence (FI), but its mechanism of action is unknown. We tested the hypothesis that TNT at one or more frequency will significantly improve underlying pathophysiology of FI through modulation of ascending and/or descending signaling pathways in the gut and brain axis and anorectal sensorimotor function. MATERIALS AND
methodsWe assessed afferent anorectal-cortical evoked potentials (CEP) following electrical stimulation of anorectum, efferent cortico-anorectal and lumbo-anorectal and sacro-anorectal motor evoked potentials (MEP) after transcranial and lumbosacral magnetic stimulations, and anorectal manometry before and after six weekly TNT sessions in FI subjects, randomized to 1, 5, or 15 Hz repetitive magnetic stimulations. Neurophysiology, anorectal sensorimotor function, and symptoms were compared to examine mechanistic effects. Co-primary measures were ano-cortical CEPs, cortico-anal MEPs, and lumbosacral-anal MEPs. Baseline and post-treatment data were compared with Wilcoxon signed-rank test and changes between the three frequencies with one-way ANOVA.
resultsThirty-three FI patients participated. After TNT, the afferent anal CEP latencies significantly decreased in the 1 Hz group compared to baseline (p = 0.0029) and 5 Hz or 15 Hz groups (p = 0.032). Cortico-anal MEPs were unchanged in all three groups. Bilateral lumbo-anal and sacro-anal MEP latencies significantly decreased with 1 Hz, lumbo-anal with 15 Hz, and sacro-anal with 5 Hz compared to baseline but without group differences. The 1 Hz group showed significant increase in anal squeeze sphincter pressure (p < 0.005) and maximum tolerable volume (p < 0.019) and demonstrated higher FI responder rate (p < 0.04) compared to the other two groups. The MEP responders were significantly correlated with FI responders (p = 0.006) in 1 Hz group.
conclusionsTNT significantly improves afferent ano-cortical signaling, efferent lumbo-anal and sacro-anal neuropathy and anorectal sensorimotor function. These neurobiologic effects were most prominent with 1 Hz frequency. TNT improves FI by modifying the underlying pathophysiology possibly through neuromodulation.
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