title: Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study.
abstract: OBJECTIVE
  This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence.
  
  
  METHODS
  Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months.
  
  
  RESULTS
  The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of < or = 120 degrees of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 "successful" patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group.
  
  
  CONCLUSIONS
  Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy.
authors.affiliation: Department of Colorectal Surgery, Epworth Hospital, University of Melbourne, Melbourne, Australia.
authors.forename: Joe J
authors.initials: JJ
authors.lastname: Tjandra
authors.forename: Miranda K Y
authors.initials: MK
authors.lastname: Chan
authors.forename: Chung Hung
authors.initials: CH
authors.lastname: Yeh
authors.forename: Carolyn
authors.initials: C
authors.lastname: Murray-Green
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004599:Electric Stimulation Therapy; D005242:Fecal Incontinence / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008160:Lumbosacral Plexus / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D018709:Statistics, Nonparametric; D016896:Treatment Outcome