title: Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence.
abstract: BACKGROUND
  Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI). Percutaneous tibial nerve stimulation (PTNS) is a newer, less invasive, treatment. The effectiveness and acceptability of these treatments have not been compared systematically.
  
  
  METHODS
  An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed. Quantitative clinical outcomes and qualitative data from patient interviews were collected for both interventions.
  
  
  RESULTS
  Forty patients (39 women; mean age 59 years) met the eligibility criteria; 23 were randomized to receive SNS and 17 to PTNS. Fifteen patients progressed to permanent SNS implantation and 16 received a full course of PTNS. Within-group effect sizes were marginally greater for SNS than for PTNS on available-case analysis. Mean(s.d.) FI episodes per week at baseline, and 3 and 6 months of follow-up were: 11·4(12·0), 4·0(4·0) and 4·9(6·9) respectively for SNS compared with 10·6(11·2), 5·8(6·9) and 6·3(6·9) for PTNS. Mean(s.d.) Cleveland Clinic Incontinence Score values at baseline, and 3 and 6 months were: 16·2(3·0), 11·1(5·2) and 10·4(5·6) for SNS versus 15·1(2·7), 11·7(4·4) and 12·1(5·2) for PTNS. Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18 patients in the SNS group compared with seven of 15 in the PTNS group. Effect estimates for SNS with chronic implanted stimulation were larger (10 of 15 patients at 6 months). Disease-specific and generic quality-of-life improvements complemented clinical outcome data. Qualitative analysis of interview data suggested that both treatments had high acceptability amongst patients.
  
  
  CONCLUSIONS
  In the short term, both SNS and PTNS provide some clinical benefit to patients with FI. Registration numbers: 2010-018728-15 and 10479 (http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10479).
authors: National Centre for Bowel Research and Surgical Innovation, Centre for Digestive Diseases, London, UK.
authors: N N
authors: NN
authors: Thin
authors: S J C
authors: SJ
authors: Taylor
authors: S A
authors: SA
authors: Bremner
authors: A V
authors: AV
authors: Emmanuel
authors: N
authors: N
authors: Hounsome
authors: N S
authors: NS
authors: Williams
authors: C H
authors: CH
authors: Knowles
mesh_terms: D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods*; D005242:Fecal Incontinence / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008160:Lumbosacral Plexus; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D011788:Quality of Life; D013979:Tibial Nerve; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome