Transcutaneous electrical nerve stimulation (TENS) is no more effective than placebo for the treatment of fecal incontinence, say French researchers.
The first, randomized, placebo-controlled trial of the treatment indicates that the placebo effect may have played a role in previous positive findings.
"The sham treatments had an unexpected lasting positive effect on symptoms, [quality of life], and voluntary contraction after 3 months," write AM Leroi (Hôpital Charles Nicolle, Rouen, France) and colleagues. "Given this placebo effect and the moderate effectiveness of TENS on [fecal incontinence] episodes, our study failed to demonstrate the superiority of active TENS over sham TENS on [fecal incontinence] episodes."
The study included 144 patients with fecal incontinence which had not responded to conservative treatments. They were given a TENS machine to use twice daily at home for 20 minutes. The electrodes attached to the patient's ankle to stimulate the posterior tibial nerve. However, half of the patients received a sham machine that did not deliver any current.
After 3 months of daily treatment, the median number of fecal incontinence episodes decreased from 1.7 per week to 1.0 per week in the active treatment group, and from 2.9 to 1.6 per week in the sham group. The number of urgency episodes per week decreased from 3.5 to 2.0 in the active treatment group, and from 4.6 to 2.3 in the sham group. However, there was no significant difference between active and sham treatment in terms of either outcome.
The authors found that the median decrease in Cleveland Clinic Severity score, which measures incontinence severity, was significantly greater in the active treatment group than the sham group, although there was no significant difference between scores in the two groups at 3 months.
There were also no significant differences between groups in relation to postpone defecation, patient assessment of treatment efficacy, or anorectal manometry.
However, the authors noted that physicians - who were blinded to treatment allocation - perceived the active treatment to be more effective.
TENS has been proposed as an alternative to sacral nerve stimulation, which can carry the risk of complications as well as high costs.
Despite the poor results, the authors say that because TENS is so well-tolerated, its potential should be explored in combination with other therapies, particularly in older patients who may be unsuitable candidates for invasive treatments.
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