Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): A double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial

The Lancet

Volumn 386, Issue 10004, 2015, Pages 1640-1648

  Knowles, Charles H ^a   Horrocks, Emma J ^a   Bremner, Stephen A ^a   Stevens, Natasha ^a   Norton, Christine ^b   O'Connell, P Ronan ^c   Eldridge, Sandra ^a  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY COLLEGE DUBLIN   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADULT DISEASE; ARTICLE; CLINICAL ASSESSMENT; CONSERVATIVE TREATMENT; CONTROLLED STUDY; DIETARY INTAKE; DOUBLE BLIND PROCEDURE; ELECTROSTIMULATION; FECES INCONTINENCE; FEMALE; FIBROMYALGIA; HOSPITAL SUBDIVISIONS AND COMPONENTS; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MEDICAL SPECIALIST; MULTICENTER STUDY; NERVE STIMULATION; NEUROMODULATION; OUTCOME ASSESSMENT; PELVIC FLOOR MUSCLE TRAINING; PERCUTANEOUS TIBIAL NERVE STIMULATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; SHAM ELECTRICAL STIMULATION; SHAM PROCEDURE; TRANSCUTANEOUS NERVE STIMULATION; TREATMENT DURATION; ADVERSE EFFECTS; AGED; CLINICAL TRIAL; COMPARATIVE STUDY; FECAL INCONTINENCE; MIDDLE AGED; PHYSIOLOGY; PROCEDURES; TIBIAL NERVE; TREATMENT OUTCOME;

AGED; DOUBLE-BLIND METHOD; FECAL INCONTINENCE; FEMALE; HUMANS; MALE; MIDDLE AGED; TIBIAL NERVE; TRANSCUTANEOUS ELECTRIC NERVE STIMULATION; TREATMENT OUTCOME;

EID: 84945479104     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)60314-2     Document Type: Article

References (28)

1. R Nelson, N Norton, E Cautley et al. Community-based prevalence of anal incontinence JAMA 274 1995 559 561
2. WE Whitehead, L Borrud, PS Goode et al. Fecal incontinence in US adults: epidemiology and risk factors Gastroenterology 137 2009 512 517
3. National Institute for Health and Care Excellence Faecal incontinence: the management of faecal incontinence in adults. NICE guideline CG 49 2007 National Institute for Health and Care Excellence London
4. SR Brown, H Wadhawan, RL Nelson Surgery for faecal incontinence in adults Cochrane Database Syst Rev 7 2013 CD001757.
5. KE Matzel, U Stadelmaier, M Hohenfellner et al. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence Lancet 346 1995 1124 1127
6. SD Wexner, JA Coller, G Devroede et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study Ann Surg 251 2010 441 449
7. EJ Horrocks, N Thin, MA Thaha et al. Systematic review of tibial nerve stimulation to treat faecal incontinence Br J Surg 101 2014 457 468
8. AT George, K Kalmar, S Sala et al. Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in faecal incontinence Br J Surg 100 2013 330 338
9. AM Leroi, L Siproudhis, I Etienney et al. Transcutaneous electrical tibial nerve stimulation in the treatment of fecal incontinence: a randomized trial Am J Gastroenterol 107 2012 1888 1896
10. KM Peters, DJ Carrico, RA Perez-Marrero et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial J Urol 183 2010 1438 1443
11. CJ Vaizey, E Carapeti, JA Cahill et al. Prospective comparison of faecal incontinence grading systems Gut 44 1999 77 80
12. N Cotterill, C Norton, KNL Avery et al. Psychometric evaluation of a new patient-completed questionnaire for evaluating anal incontinence symptoms and impact on quality of life: the ICIQ-B Dis Colon Rectum 54 2011 1235 1250
13. E Eypasch, JI Williams, S Wood-Dauphinee et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument Br J Surg 82 1995 216 222
14. TH Rockwood, JM Church, JW Fleshman et al. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence Dis Colon Rectum 43 2000 9 17
15. AL Stewart, RD Hays, JE Ware Jr The MOS short-form general health survey. Reliability and validity in a patient population Med Care 26 1988 724 735
16. EuroQoL Group EuroQol - a new facility for the measurement of health-related quality of life Health Policy 19 1990 199 208
17. W Graf, A Mellgren, KE Matzel et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial Lancet 377 2011 997 1003
18. P Enck, B Horing, K Weimer, S Klosterhalfen Placebo responses and placebo effects in functional bowel disorders Eur J Gastroenterol Hepatol 24 2012 1 8
19. JR Carpenter, H Goldstein, MG Kenward REAL COM-IMPUTE software for multilevel multiple imputation with mixed response types J Stat Soft 45 2011 1 12
20. BC Kahan, TP Morris Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Stat Med 32 2013 1136 1149
21. SA Asari, G Meurette, S Mantoo et al. Percutaneous tibial nerve versus sacral nerve stimulation for faecal incontinence: a comparative case-matched study Colorectal Dis 16 2014 O393 O399
22. A Hotouras, J Murphy, M Allison et al. Prospective clinical audit of two neuromodulatory treatments for fecal incontinence: sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) Surg Today 44 2014 2124 2130
23. G Pacheco-Lopez, H Engler, MB Niemi et al. Expectations and associations that heal: immunomodulatory placebo effects and its neurobiology Brain Behav Immun 20 2006 430 446
24. F Musial, S Klosterhalfen, P Enck Placebo responses in patients with gastrointestinal disorders World J Gastroenterol 13 2007 3425 3429
25. CJ Vaizey Faecal incontinence: standardizing outcome measures Colorectal Dis 16 2014 156 158
26. NN Thin, SJ Taylor, SA Bremner et al. Randomised clinical trial of sacral and percutaneous tibial nerve stimulation in patients with faecal incontinence Br J Surg 102 2015 349 358
27. A Hotouras, MA Thaha, D Boyle et al. Short-term outcome following percutaneous tibial nerve stimulation (PTNS) for faecal incontinence: a single-centre prospective study Colorectal Dis 14 2011 1101 1105
28. National Institute for Health and Care Excellence NICE Interventional Procedure Guideline (IPG395) 2011 National Institute for Health and Care Excellence London