title: 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: BACKGROUND
  Faecal 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.
  
  
  OBJECTIVE
  To assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.
  
  
  METHODS
  Multicentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.
  
  
  METHODS
  Eighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.
  
  
  METHODS
  Participants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.
  
  
  METHODS
  PTNS 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.
  
  
  METHODS
  Outcome 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).
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  PTNS 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN88559475.
  
  
  BACKGROUND
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.
authors.affiliation: National Centre for Bowel Research and Surgical Innovation, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Horrocks
authors.affiliation: Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Bremner
authors.affiliation: Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Natasha
authors.initials: N
authors.lastname: Stevens
authors.affiliation: Florence Nightingale Faculty of Nursing and Midwifery, King's College London, London, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Norton
authors.affiliation: National Centre for Bowel Research and Surgical Innovation, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Gilbert
authors.affiliation: School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.
authors.forename: P Ronan
authors.initials: PR
authors.lastname: O'Connell
authors.affiliation: Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Sandra
authors.initials: S
authors.lastname: Eldridge
authors.affiliation: National Centre for Bowel Research and Surgical Innovation, Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Charles H
authors.initials: CH
authors.lastname: Knowles
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005242:Fecal Incontinence / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013979:Tibial Nerve / Q000502:physiology*; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D055815:Young Adult