• M Rydningen, T Dehli, T Wilsgaard, A Rydning, M Kumle, R O Lindsetmo, and S Norderval.
• Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway.
• Colorectal Dis. 2017 May 1; 19 (5): O134-O144.

AimThe 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).MethodThis 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.ResultsFifty-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).ConclusionSNM 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.Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

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