Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Abstract

BackgroundFaecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted.ObjectivesTo assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.DesignMulticentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.SettingEighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.ParticipantsParticipants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.InterventionsPTNS was delivered via the Urgent®PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer’s protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation.Main outcome measuresOutcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs).ResultsIn total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28;p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta –2.3, 95% CI –4.2 to –0.3;p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark’s Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.ConclusionsPTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI.Trial registrationCurrent Controlled Trials ISRCTN88559475.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

Digital breast tomosynthesis for breast cancer screening and diagnosis in women with dense breasts – a systematic review and meta-analysis

“…Studies differed in terms of study setting, threshold definitions, breast density categorization, reading protocol and whether DBT was used alone or with DM. Among the five diagnostic studies, four studies using DBT and DM reported sensitivity and specificity [ 12 , 18 , 21 , 30 ] and one study reported recall rate [ 17 ]. It was possible to calculate CDR from three studies which reported sensitivity and specificity [ 12 , 18 , 21 ].…”

“…. One study did not specify the reference standard for negative images [ 21 ]. One third of the studies were at high risk of bias regarding flow and timing domain because DBT and DM were performed in different periods of time [ 24 – 27 , 29 ].…”

“…In the diagnostic setting, sensitivity of DBT ranged from 84% (95% CI 71–93) [ 30 ] to 89% (95% CI 81–95) [ 12 ], being higher than the sensitivity of DM which ranged from 69% (95% CI 58–79) [ 12 ] to 86% (95% CI 81–89) [ 21 ] (Fig. 2 ).…”

“…2 ). The specificity of DBT ranged from 72% (95% CI 68–72) [ 21 ] to 93% (95% CI 89–96) [ 18 ] and was not different from the specificity of DM which ranged from 57% (95% CI 55–59) [ 21 ] to 94% (95% CI 91–97) [ 18 ] (Fig. 2 ).…”

“…Firstly, some studies included asymptomatic or symptomatic population. Although aiming to investigate the accuracy of DBT and DM in BC screening, some studies included women who were recalled after screening [ 12 , 17 , 21 , 30 ]. By doing so, they obtained populations recalled to assessment which have higher cancer rates than unselected asymptomatic populations.…”