title: Transanal submucosal polyacrylamide gel injection treatment of anal incontinence: a randomized controlled trial.
abstract: BACKGROUND
  The efficacious and safe use of transurethral injections of polyacrylamide hydrogel (Bulkamid(®)) in women with stress urinary incontinence suggests that it may be suitable also for treatment of anal incontinence. We aimed to determine the effectiveness and safety of polyacrylamide hydrogel when used as a transanal submucosal bulking agent in women with anal incontinence.
  
  
  METHODS
  Thirty women with a diagnosis of anal incontinence and a Cleveland Clinic Incontinence Score (CCIS) >10 were randomized to three different techniques of transanal submucosal injections using polyacrylamide hydrogel. Follow up was performed at 2, 6 and 12 months using CCIS and the Fecal Incontinence Quality of Life scale (FIQL).
  
  
  RESULTS
  In all, 29 of the 30 women completed the follow up. Approximately half of the women requested a re-injection at the 6-month visit. The overall CCIS improved significantly from baseline (14.7. SD 2.5) to 1 year (12.4. SD 3.1) (p = 0.003). There was a significant improvement with regard to the occurrence of loose fecal incontinence (p = 0.014) but not for solid fecal incontinence (p = 0.28). At 1 year the FIQL domains of coping-behavior, depression, and embarrassment showed significant improvements (p = 0.012, p = 0.007 and p = 0.007, respectively). We recorded no adverse events related either to the injection technique or the biomaterial. There were no significant differences between the treatment groups in either CCIS or FIQL scores.
  
  
  CONCLUSIONS
  Transanal submucosal injection of polyacrylamide hydrogel resulted in a modest although significant overall improvement in anal incontinence symptom scores with corresponding improvements in several domains of quality of life, regardless of injection volume.
authors: Stockholm Urogynecological Clinic, Stockholm, Sweden.|Department of Clinical Sciences, Karolinska Institute Danderyd Hospital, Danderyd, Sweden.|Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
authors: Daniel
authors: http://orcid.org/0000-0002-0648-3758
authors: D
authors: Altman
authors: Division of Surgery, Department of Clinical Sciences, Karolinska Institute, Danderyd Hospital, Danderyd, Sweden.
authors: Fredrik
authors: http://orcid.org/0000-0003-2635-5996
authors: F
authors: Hjern
authors: Department of Clinical Sciences, Karolinska Institute Danderyd Hospital, Danderyd, Sweden.|Gynecological Clinic, Sophiahemmet Hospital, Stockholm, Sweden.
authors: Jan
authors: http://orcid.org/0000-0001-9656-8394
authors: J
authors: Zetterström
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D001003:Anal Canal / Q000187:drug effects / Q000503:physiopathology; D005242:Fecal Incontinence / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007267:Injections / Q000379:methods; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000180:Acrylic Resins; D005765:Gastrointestinal Agents; C016680:polyacrylamide gels
keywords: Anal incontinence; injection; polyacrylamide; randomized trial