PubMed:26347970 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PubMed/sourceid/26347970","sourcedb":"PubMed","sourceid":"26347970","source_url":"http://www.ncbi.nlm.nih.gov/pubmed/26347970","text":"Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation for Fecal Incontinence.\nBACKGROUND: Fecal incontinence is a socially disabling condition that affects ≤15% of adults. Neuromodulatory treatments for fecal incontinence are now well established. Less invasive, cheaper, and more ambulatory forms of neuromodulation are under exploration.\nOBJECTIVE: The purpose of this study was to assess the acceptability and safety of a new ambulatory tibial nerve stimulation device and to determine clinical effect size for 2 differing regimens of therapy.\nDESIGN: This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial.\nSETTINGS: The study was conducted at 7 United Kingdom trial centers. Patients were initially reviewed in the trial center, with subsequent applications of the device performed in the patients home setting.\nPATIENTS: A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study.\nINTERVENTION: The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments).\nMAIN OUTCOME MEASURES: Standard fecal incontinence outcome tools (bowel diary, symptom severity score, and generic quality-of-life instruments) were used to collect data at baseline and at 2 weeks posttreatment cessation.\nRESULTS: A total of 22 patients were randomly assigned to the 1-hour group and 21 to the 4-hour group. Improvements in fecal incontinence outcomes were observed for both groups, including median urge incontinence episodes per week at baseline and posttreatment (1-hour group 2.0 to 0.5 versus 4-hour group 4.0 to 1.0) and deferment time (1-hour group 2.0 to 2.0 minutes versus 4-hour group 0.5 to 5.0 minutes). Accompanying changes were observed in physical functioning domains of quality-of-life instruments. There were no adverse events, and the treatment was highly acceptable to patients.\nLIMITATIONS: Limitations included the pilot design and lack of control arm in the study. Future trials would need to address these limitations.\nCONCLUSIONS: This pilot study provides evidence that transcutaneous tibial nerve stimulation with a new ambulatory device is safe and acceptable for the management of fecal incontinence. Additional study is warranted to investigate clinical effectiveness.","tracks":[{"project":"maxiaofeng52_800","denotations":[{"id":"T1","span":{"begin":151,"end":169},"obj":"DP"},{"id":"T2","span":{"begin":119,"end":137},"obj":"DP"},{"id":"T3","span":{"begin":264,"end":282},"obj":"DP"},{"id":"T4","span":{"begin":992,"end":1010},"obj":"DP"},{"id":"T5","span":{"begin":1226,"end":1244},"obj":"DP"},{"id":"T6","span":{"begin":1535,"end":1553},"obj":"DP"},{"id":"T7","span":{"begin":2320,"end":2338},"obj":"DP"}],"attributes":[{"subj":"T1","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T2","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T3","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T4","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T5","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T6","pred":"source","obj":"maxiaofeng52_800"},{"subj":"T7","pred":"source","obj":"maxiaofeng52_800"}]},{"project":"yangbin123xm_800_3","denotations":[{"id":"T1","span":{"begin":119,"end":137},"obj":"DP"},{"id":"T2","span":{"begin":151,"end":169},"obj":"DP"},{"id":"T3","span":{"begin":264,"end":282},"obj":"DP"},{"id":"T4","span":{"begin":992,"end":1010},"obj":"DP"},{"id":"T5","span":{"begin":1226,"end":1244},"obj":"DP"},{"id":"T6","span":{"begin":1535,"end":1553},"obj":"DP"},{"id":"T7","span":{"begin":2320,"end":2338},"obj":"DP"}],"attributes":[{"subj":"T1","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T2","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T3","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T4","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T5","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T6","pred":"source","obj":"yangbin123xm_800_3"},{"subj":"T7","pred":"source","obj":"yangbin123xm_800_3"}]},{"project":"chenxin_473849_800_3","denotations":[{"id":"T1","span":{"begin":119,"end":137},"obj":"DP"},{"id":"T2","span":{"begin":151,"end":169},"obj":"DP"},{"id":"T3","span":{"begin":264,"end":282},"obj":"DP"},{"id":"T4","span":{"begin":992,"end":1010},"obj":"DP"},{"id":"T5","span":{"begin":1226,"end":1244},"obj":"DP"},{"id":"T6","span":{"begin":1535,"end":1553},"obj":"DP"},{"id":"T7","span":{"begin":2320,"end":2338},"obj":"DP"}],"attributes":[{"subj":"T1","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T2","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T3","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T4","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T5","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T6","pred":"source","obj":"chenxin_473849_800_3"},{"subj":"T7","pred":"source","obj":"chenxin_473849_800_3"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"maxiaofeng52_800","color":"#93e2ec","default":true},{"id":"yangbin123xm_800_3","color":"#ecdc93"},{"id":"chenxin_473849_800_3","color":"#c293ec"}]}]}}