Transcutaneous electrical tibial nerve stimulation in the treatment of fecal incontinence: a randomized trial (CONSORT 1a).

OBJECTIVES: The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat fecal incontinence (FI), its efficacy has never been proved using controlled trials. METHODS: In this randomized, double-blind, sham-controlled trial, 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events. RESULTS: No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47%) who received the active TENS treatment exhibited a >30% decrease in the FI severity score compared with 19 patients (27%) who received the sham treatment (odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (P=0.01). One minor therapy-related adverse event was observed (1.5%) (see Supplementary Consort 1b). CONCLUSIONS: We failed to demonstrate any benefit of TENS on our primary end-point.

A randomized controlled study assessing outcome, cognition, autonomy and quality of life in over 70-year-old patients after aneurysmal subarachnoid hemorrhage.

BACKGROUND: Current aging of the population with good physiological status and the increasing incidence of subarachnoid hemorrhage (SAH) in elderly patients has enhanced the benefit of treatment in terms of independence and long-term quality of life (QoL). METHODS: From November 1, 2008 to October 30, 2012, 351 patients aged 70 years or older with aneurysmal SAH underwent adapted treatment: endovascular coiling (EV) for 228 (65%) patients, microsurgical clipping (MS) for 75 (29.3%) or conservative treatment for 48 (13.7%). Forty-one of these were randomized to EV (n=20) or to MS (n=21). The objectives were to determine the proportion of patients with modified Rankin Scale score≤2 (independence) at 1 year, and, secondarily, to compare cognitive function on the Mini-Mental State Examination (MMSE), autonomy on the Activities of Daily Living Index (ADLI) and Instrumental Activities of Daily Living scale (IADL), and QoL, in the prospective and randomized arms, at 1 year. RESULTS: At 1 year, with 1 loss to follow-up in the EV arm, 11 patients (55%) were independent after EV occlusion and 8 (38.1%) after MS exclusion, without significant difference (P=0.29). Mortality was higher after MS during the first 2 postoperative months, and thereafter the difference between MS and EV ceased to be significant. Cognitive function and autonomy scores were similar in both arms. CONCLUSION: In elderly patients treated for aneurysmal SAH, approximately 50% were independent at 1 year, with conserved cognition and autonomy. EV and MS are valid procedures in this population, with similar results at 1 year in terms of independence, cognition, autonomy, and QoL.