title: Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial.
abstract: OBJECTIVE
  The objective is to test if the injection of a bulking agent in the anal canal is superior to sphincter training with biofeedback in the treatment of anal incontinence.
  
  
  BACKGROUND
  Anal incontinence is traditionally treated with conservative measures, such as pads and constipating medicine. If this fails, sphincter training with biofeedback is often offered before more advanced surgical procedures are considered. The injection of a bulking agent in the anal canal is a relatively new and promising treatment option.
  
  
  METHODS
  In a randomized, controlled, evaluator-blinded trial, 126 adult patients with anal incontinence were randomly assigned to a transanal, submucosal injection of 4 x 1 mL of dextranomer in hyaluronic acid or to sphincter training with biofeedback. The primary outcome was severity of incontinence, evaluated by St Mark's score for incontinence (0 = continence to 24 = complete incontinence) assessed at 2 years after the start of treatment. A mixed models analysis was applied.
  
  
  RESULTS
  Of the 126 participants, 64 patients were randomly assigned to anal injections, and among them the mean St Mark's score improved from 12.9 (95% CI: 11.8-14.0) at baseline to 8.3 (95% CI: 6.7-9.8) at the end of follow up. Among the 62 patients who were assigned to sphincter training with biofeedback, there was a corresponding improvement in St Mark's score from 12.6 (95% CI: 11.4-13.8) to 7.2 (95% CI: 7.2-8.8). Comparisons of St Mark's scores between the groups showed no differences in effect between treatments.
  
  
  CONCLUSIONS
  The efficacy of anal injections and biofeedback in treating anal incontinence did not differ in this randomized, single-blinded, controlled trial.
authors.affiliation: Department of Gastrointestinal Surgery, University Hospital of North Norway, Tromsø, Norway. trond.dehli@unn.no
authors.forename: Trond
authors.initials: T
authors.lastname: Dehli
authors.forename: Arvid
authors.initials: A
authors.lastname: Stordahl
authors.forename: Lars J
authors.initials: LJ
authors.lastname: Vatten
authors.forename: Pål R
authors.initials: PR
authors.lastname: Romundstad
authors.forename: Kjersti
authors.initials: K
authors.lastname: Mevik
authors.forename: Ylva
authors.initials: Y
authors.lastname: Sahlin
authors.forename: Rolv O
authors.initials: RO
authors.lastname: Lindsetmo
authors.forename: Barthold
authors.initials: B
authors.lastname: Vonen
mesh_terms: D001003:Anal Canal / Q000503:physiopathology*; D001676:Biofeedback, Psychology; D016001:Confidence Intervals; D003911:Dextrans / Q000008:administration & dosage* / Q000009:adverse effects; D004599:Electric Stimulation Therapy; D005242:Fecal Incontinence / Q000503:physiopathology* / Q000628:therapy*; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
chemical_list: D003911:Dextrans; C013471:dextranomer