title: Autologous skeletal-muscle-derived cell injection for anal incontinence due to obstetric trauma: a 5-year follow-up of an initial study of 10 patients.
abstract: OBJECTIVE
  Our aim was to determine whether the benefits of autologous skeletal-muscle-derived cell injection to treat obstetric anal incontinence are sustained at 5 years.
  
  
  METHODS
  An observational study was performed of 10 women suffering from obstetric anal incontinence refractory to non-surgical therapy. Autologous skeletal-muscle-derived cells were injected into the external sphincter defect under ultrasound guidance. Incontinence diaries and quality of life questionnaires were obtained pre-implantation and annually after implantation for 5 years. Anal physiology testing was performed before implantation and at 1, 2 and 5 years after implantation. The end-points included were adverse events, Wexner incontinence scores, incontinence episodes, anal squeeze pressures and quality of life over 5 years. An independent statistician used multilevel linear regression to analyse changes in repeated measures over time. Any skewed distributions were log transformed prior to analysis.
  
  
  RESULTS
  No procedure-related adverse events occurred and haematological and biochemical parameters were normal during the 5-year period. There were sustained significant improvements in the Wexner incontinence score and reduced frequency of defaecation and number of incontinence episodes (all comparisons P < 0.001). Anal resting and squeeze pressures showed sustained improvement (all P < 0.001) and quality of life improved overall (P < 0.001), including all submeasures studied (P < 0.001).
  
  
  CONCLUSIONS
  Autologous skeletal-muscle-derived cells to treat obstetric anal incontinence resulted in sustained improvement in incontinence episodes, physiological measurements of anal function and quality of life at 5 years.
authors.affiliation: Department of Obstetrics and Gynaecology, Medical University of Graz, Graz, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Frudinger
authors.affiliation: General Surgery, Medical University of Graz, Graz, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Pfeifer
authors.affiliation: B-K Medical, Quickborn, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Paede
authors.affiliation: Department of Obstetrics and Gynaecology, Medical University of Graz, Graz, Austria.
authors.forename: V
authors.initials: V
authors.lastname: Kolovetsiou-Kreiner
authors.affiliation: Innovacell Biotechnologie AG, Innsbruck, Austria.
authors.forename: R
authors.initials: R
authors.lastname: Marksteiner
authors.affiliation: Centre for Medical Imaging, University College London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Halligan
mesh_terms: D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000293:injuries* / Q000503:physiopathology*; D003672:Defecation; D036861:Delivery, Obstetric / Q000009:adverse effects*; D005242:Fecal Incontinence / Q000209:etiology* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006306:Health Surveys; D006801:Humans; D007273:Injections, Intramuscular; D008365:Manometry; D008875:Middle Aged; D032448:Myoblasts, Skeletal / Q000637:transplantation*; D011788:Quality of Life; D012720:Severity of Illness Index; D014182:Transplantation, Autologous
keywords: anal; functional; incontinence