Trial reportTechniques in coloproctology2025
Sacral neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence - results from a randomised study with a one-stage implant procedure.
Trial report in Techniques in coloproctology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
introductionIn sacral neuromodulation (SNM), the stimulation intensity is set at the sensory threshold (ST) level. However, subsensory stimulation as low as 50% of ST has proven effective in reducing faecal incontinence episodes.
aimTo explore the relationship between functional outcomes and varying subsensory stimulation amplitude in newly implanted patients.
methodThis randomised, double-blind study was designed to include patients with ≥ 1 faecal incontinence episodes/week despite maximal conservative therapy. As part of another trial, patients were offered a one-stage procedure. Postoperatively, patients were randomised into two groups. G-1 received stimulation at 0.05 V, at 50% and 90% of the ST in three 4-week periods, followed by 12 weeks of stimulation at the ST. G-2 received stimulation at 90% of the ST in three 4-week periods, followed by 12 weeks of stimulation at ST. Patients were evaluated after each period using St. Marks's Incontinence Score and a visual analogue scale (VAS) for patient satisfaction regarding social function, bowel function and quality-of-life, along with a bowel habit diary.
resultsIn total, 73 patients with a median age of 60 years [interquartile range (IQR: 50-69 years)] completed the trial. Faecal incontinence episodes were significantly reduced at all follow-ups, with no differences between groups. The only statistical difference between groups was deltaVAS for bowel function after 4 weeks. In G-1 with ultra-low stimulation amplitude [0.05 V - equivalent to 9.6% (IQR: 6.5-13.4) of ST], the improvement compared with baseline was 30 points (IQR: 10-50) significantly lower than G-2 with an improvement of 50 points (IQR: 10-70) (p-value: 0.05).
conclusionsSubsensory stimulation is feasible in newly implanted patients with faecal incontinence. An amplitude of 0.05 V is as effective on the functional outcomes as stimulation with higher amplitudes.
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