Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury – a randomized controlled trial

Aim The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a sub-mucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS). Method 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 versus 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% 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 9 minor adverse events in the SNM group compared to seven in the Permacol® group (p=0.77). Conclusion 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. This article is protected by copyright. All rights reserved.