Ping Liu, Shan Lyu, Eduardo Mireles-Cabodevila, Andrew G Miller, Fai A Albuainain, Miguel Ibarra-Estrada, Jie Li
Survey of Ventilator Waveform Interpretation Among ICU Professionals
Respiratory care
nonrandomised studies assessing intrarectal botulinum toxin type bonta injections faecal incontinence promising aimed evaluate efficacy bonta treatment faecal incontinence randomised study randomised doubleblind placebocontrolled study included adult patients least one urgency faecal incontinence episode per week least 3 months experienced failure conservative surgical treatment eight french specialist hospital units skills manage patients faecal incontinence patients randomly assigned 11 central web form receive intrarectal submucosal injections either 200 units bonta botox allergan irvine ca usa bonta group equivalent volume saline placebo group stratified cleveland clinic severity scores ccs score 12 12 patients investigators study site staff sponsor personnel masked treatment allocation 6month visit primary endpoint number episodes faecal incontinence urgency per day assessed using 21day patient bowel diaries 3 months treatment primary analysis performed using modified intentiontotreat mitt approach ie randomised patients received treatment adjustment baseline faecal incontinence urgency episodes final data collection 6 months injections patients unmasked offered bonta treatment placebo group rescue therapy without masking additional 6 months safety followup trial registered clinicaltrialsgov number nct02414425 nov 25 2015 nov 25 2020 randomly assigned 200 patients receive either bonta n100 placebo n100 injections due withdrawals injections 96 patients included bonta group 95 patients included placebo group mitt analysis mean number faecal incontinence urgency episodes per day bonta group decreased 19 sd 22 baseline 08 18 3 months injections 14 11 10 10 placebo group baselineadjusted mean group difference 3 months estimated 051 95 ci 080 021 p00008 serious treatmentrelated adverse events reported trial frequently reported nonserious adverse event treatment related following bonta placebo injections constipation reported 68 40 169 patients received bonta injections 38 40 95 patients received placebo injections bonta injections efficacious treatment urge faecal incontinence research define optimum selection criteria dose site injection reinjection frequency longterm results general direction healthcare french ministry health