title: Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial.
abstract: OBJECTIVE
  The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS).
  
  
  METHODS
  This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6 months. Secondary outcomes were changes in the disease-specific quality of life (FIQL) and urinary incontinence (ICIQ-UI-SF) scores.
  
  
  RESULTS
  Fifty-eight women were randomly assigned to SNM (n = 30) and Permacol® (n = 28). The reduction in the St Mark's score between baseline and 6 months was 11.2 (SD 5.3) in the SNM group vs 2.3 (SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P < 0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P < 0.001), 1.05 (0.62-1.47, P < 0.001), 0.52 (95% CI: 0.16-0.87, P = 0.005) and 0.95 (95% CI: 0.50-1.40, P < 0.001), respectively, in favour of SNM. The difference in the ICIQ-UI-SF was 5.0 (95% CI: 1.97-8.02, P = 0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group (P = 0.77).
  
  
  CONCLUSIONS
  SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ-UI-SF and the change of the FIQL in women with faecal incontinence following OASIS.
authors.affiliation: Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway.
authors.forename: M
authors.initials: M
authors.lastname: Rydningen
authors.affiliation: Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Dehli
authors.affiliation: Department of Community Medicine, The Arctic University of Norway, Tromsoe, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Wilsgaard
authors.affiliation: Department of Gastroenterological Surgery, St Olav's Hospital, Trondheim, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Rydning
authors.affiliation: Department of Radiology, University Hospital of North Norway, Tromsoe, Norway.|Narvik University College, Narvik, Norway.
authors.forename: M
authors.initials: M
authors.lastname: Kumle
authors.affiliation: Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway.|Institute of Clinical Medicine, The Arctic University of Norway, Tromsoe, Norway.
authors.forename: R O
authors.initials: RO
authors.lastname: Lindsetmo
authors.affiliation: Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway.|Institute of Clinical Medicine, The Arctic University of Norway, Tromsoe, Norway.|National Advisory Board of Continence and Pelvic Floor Health of Norway, University Hospital of North Norway, Tromsoe, Norway.
authors.forename: S
authors.initials: S
authors.lastname: Norderval
mesh_terms: D000368:Aged; D001003:Anal Canal / Q000293:injuries*; D003094:Collagen / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D036861:Delivery, Obstetric / Q000009:adverse effects; D005242:Fecal Incontinence / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D007267:Injections; D054368:Laxatives / Q000008:administration & dosage*; D008875:Middle Aged; D009664:Norway; D011247:Pregnancy; D012447:Sacrum / Q000294:innervation; D016037:Single-Blind Method; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D054368:Laxatives; C422414:Permacol; D003094:Collagen
keywords: Faecal incontinence; bulking agents; obstetric anal sphincter injury; pelvic floor disorders; sacral neuromodulation