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

AimOur aim was to determine whether the benefits of autologous skeletal-muscle-derived cell injection to treat obstetric anal incontinence are sustained at 5years. MethodAn 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 5years. Anal physiology testing was performed before implantation and at 1, 2 and 5years after implantation. The end-points included were adverse events, Wexner incontinence scores, incontinence episodes, anal squeeze pressures and quality of life over 5years. An independent statistician used multilevel linear regression to analyse changes in repeated measures over time. Any skewed distributions were log transformed prior to analysis. ResultsNo 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). ConclusionAutologous 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 5years.