M Rydningen1, T Dehli1, T Wilsgaard2, A Rydning3, M Kumle4,5, R O Lindsetmo1,6, S Norderval1,6,7. 1. Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsoe, Norway. 2. Department of Community Medicine, The Arctic University of Norway, Tromsoe, Norway. 3. Department of Gastroenterological Surgery, St Olav's Hospital, Trondheim, Norway. 4. Department of Radiology, University Hospital of North Norway, Tromsoe, Norway. 5. Narvik University College, Narvik, Norway. 6. Institute of Clinical Medicine, The Arctic University of Norway, Tromsoe, Norway. 7. National Advisory Board of Continence and Pelvic Floor Health of Norway, University Hospital of North Norway, Tromsoe, Norway.
Abstract
AIM: The 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). 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 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). 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. Colorectal Disease
RCT Entities:
AIM: The 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). 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 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). 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. Colorectal Disease
Authors: Sadé L Assmann; Daniel Keszthelyi; Jos Kleijnen; Foteini Anastasiou; Elissa Bradshaw; Ann E Brannigan; Emma V Carrington; Giuseppe Chiarioni; Liora D A Ebben; Marc A Gladman; Yasuko Maeda; Jarno Melenhorst; Giovanni Milito; Jean W M Muris; Julius Orhalmi; Daniel Pohl; Yvonne Tillotson; Mona Rydningen; Saulius Svagzdys; Carolynne J Vaizey; Stephanie O Breukink Journal: United European Gastroenterol J Date: 2022-03-18 Impact factor: 6.866