AIM: Transcutaneous electrical nerve stimulation (TENS) is a possible alternative to sacral nerve stimulation because the neurophysiologic targets might be similar but the former method is non-invasive and cheaper. The aim of the study was to assess both symptom and quality of life (QoL) improvements in patients suffering from severe FI. METHODS:Thirty two patients (M/F, 30/2; age, 61 +/- 13 years) were enrolled in a pilot trial because they suffered from a severe and stable FI (Cleveland Score14.5 +/- 2.8 [11-20]) for a long duration (95 +/- 91 months). TENS was delivered 20 min bis in die at home (Schwa Medico, P3). Assessment was realized at 1, 3, and 6 months with both semi-directive and self-administered questionnaires. Main endpoint was the quantified success rate after 1 month of follow-up. RESULTS:Mean subjective improvement was 26 +/- 30%: 20 (63%) patients reported some degree of improvement and 10 (32%) at least a 25% improvement in fecal incontinence. The Cleveland score significantly decreased at 1 (11 +/- 4; p < 0.001), 3 (11 +/- 5; p < 0.001), and 6 (10 +/- 5; p < 0.001) months. All subscales of QoL were significantly improved after a 3-month period of stimulation. However, constipation score and number of pads did not change. There was no adverse event. CONCLUSION:TENS provides slight improvement in FI. This justifies both neurophysiology assessment and randomized controlled studies before further diffusion of the technique.
RCT Entities:
AIM: Transcutaneous electrical nerve stimulation (TENS) is a possible alternative to sacral nerve stimulation because the neurophysiologic targets might be similar but the former method is non-invasive and cheaper. The aim of the study was to assess both symptom and quality of life (QoL) improvements in patients suffering from severe FI. METHODS: Thirty two patients (M/F, 30/2; age, 61 +/- 13 years) were enrolled in a pilot trial because they suffered from a severe and stable FI (Cleveland Score14.5 +/- 2.8 [11-20]) for a long duration (95 +/- 91 months). TENS was delivered 20 min bis in die at home (Schwa Medico, P3). Assessment was realized at 1, 3, and 6 months with both semi-directive and self-administered questionnaires. Main endpoint was the quantified success rate after 1 month of follow-up. RESULTS: Mean subjective improvement was 26 +/- 30%: 20 (63%) patients reported some degree of improvement and 10 (32%) at least a 25% improvement in fecal incontinence. The Cleveland score significantly decreased at 1 (11 +/- 4; p < 0.001), 3 (11 +/- 5; p < 0.001), and 6 (10 +/- 5; p < 0.001) months. All subscales of QoL were significantly improved after a 3-month period of stimulation. However, constipation score and number of pads did not change. There was no adverse event. CONCLUSION: TENS provides slight improvement in FI. This justifies both neurophysiology assessment and randomized controlled studies before further diffusion of the technique.
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