Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow‐up study
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2025
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| author | Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles |
| author_facet | Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles |
| collection | Wiley Open Access |
| contents | Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow‐up study Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles Colorectal Disease Abstract Aim Sacral neuromodulation (SNM) is considered the first‐line surgical treatment in adults with refractory faecal incontinence (FI). However, its clinical efficacy has not been rigorously tested in a trial setting. Method Randomised, multicentre, double‐blind crossover trial (two 16‐week periods) of active stimulation versus sham, and open‐label follow‐up to 58 weeks. Participants: adults aged 18–80 with refractory FI. Interventions: Active : subsensory sacral nerve stimulation with an implanted pulse generator; Sham : identical implant but turned off. Primary outcome: FI episodes per week (paper bowel diary) during final 4 weeks of crossover periods (allowing 12 weeks' washout). Randomised allocation (1:1) to arm 1 (SNM/sham) or arm 2 (sham/SNM). Blinding: participants, surgeons, assessors; tamper‐proof tape‐masked stimulation settings. Sample size: 80 patients to detect a 30% reduction in episodes. Groups compared using a paired t ‐test, and treatment effects summarised by mean differences. Results Trial delivery was severely affected by COVID‐19. Thirty‐nine patients of 220 screened (arm 1: N = 17; arm 2: N = 22) were recruited at 10 sites (February 2018–July 2022), of whom only 16 (arm 1: N = 9; arm 2: N = 7) had complete primary outcome data. Of the 39, 19 completed follow‐up to 58 weeks. SNM conferred a non‐significant reduction in mean FI episodes per week compared to sham (−0.795 [95% CI: −1.5 to 0.0], p = 0.06). Improvements were observed in FI symptoms at 58 weeks compared to baseline (FI episodes per week: 3.2 [SD 3.3] vs. 6.2 [SD 5.9]). Conclusions The SUBSoNIC trial failed to find conclusive evidence of the experimental efficacy of SNM. Further demonstration of experimental efficacy remains important as SNM is a high‐cost and invasive therapy. 10.1111/codi.70308 http://creativecommons.org/licenses/by/4.0/ |
| doi_str_mv | 10.1111/codi.70308 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_codi_70308 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow‐up study Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles Colorectal Disease Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow‐up study Paul F. Vollebregt Yan Li Goh Anil Bagul Claire Chan Tom Dudding Paul Furlong Shaheen Hamdy Joanne Haviland Richard Hooper James Jones Eleanor McAlees Christine Norton P. Ronan O'Connell Michael Powar S. Mark Scott Natasha Stevens Kerry Tubby Sian Worthen Yuk Lam Wong Charles H. Knowles Colorectal Disease Abstract Aim Sacral neuromodulation (SNM) is considered the first‐line surgical treatment in adults with refractory faecal incontinence (FI). However, its clinical efficacy has not been rigorously tested in a trial setting. Method Randomised, multicentre, double‐blind crossover trial (two 16‐week periods) of active stimulation versus sham, and open‐label follow‐up to 58 weeks. Participants: adults aged 18–80 with refractory FI. Interventions: Active : subsensory sacral nerve stimulation with an implanted pulse generator; Sham : identical implant but turned off. Primary outcome: FI episodes per week (paper bowel diary) during final 4 weeks of crossover periods (allowing 12 weeks' washout). Randomised allocation (1:1) to arm 1 (SNM/sham) or arm 2 (sham/SNM). Blinding: participants, surgeons, assessors; tamper‐proof tape‐masked stimulation settings. Sample size: 80 patients to detect a 30% reduction in episodes. Groups compared using a paired t ‐test, and treatment effects summarised by mean differences. Results Trial delivery was severely affected by COVID‐19. Thirty‐nine patients of 220 screened (arm 1: N = 17; arm 2: N = 22) were recruited at 10 sites (February 2018–July 2022), of whom only 16 (arm 1: N = 9; arm 2: N = 7) had complete primary outcome data. Of the 39, 19 completed follow‐up to 58 weeks. SNM conferred a non‐significant reduction in mean FI episodes per week compared to sham (−0.795 [95% CI: −1.5 to 0.0], p = 0.06). Improvements were observed in FI symptoms at 58 weeks compared to baseline (FI episodes per week: 3.2 [SD 3.3] vs. 6.2 [SD 5.9]). Conclusions The SUBSoNIC trial failed to find conclusive evidence of the experimental efficacy of SNM. Further demonstration of experimental efficacy remains important as SNM is a high‐cost and invasive therapy. 10.1111/codi.70308 http://creativecommons.org/licenses/by/4.0/ |
| title | Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow‐up study |
| topic | Colorectal Disease |
| url | https://onlinelibrary.wiley.com/doi/10.1111/codi.70308 |