Randomized clinical trial of sacral versus percutaneous tibialnerve stimulation in patients with faecal incontinence

Thin, N N, Taylor, S J C, Bremner, S A, Emmanuel, A V, Hounsome, N, Williams, N S and Knowles, C (2015) Randomized clinical trial of sacral versus percutaneous tibialnerve stimulation in patients with faecal incontinence. BJS Open, 102 (4). pp. 349-358. ISSN 2474-9842

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Background: Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI).Percutaneous tibial nerve stimulation (PTNS) is a newer, less invasive, treatment. The effectiveness andacceptability of these treatments have not been compared systematically.Methods: An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitativestudy was performed. Quantitative clinical outcomes and qualitative data from patient interviews werecollected for both interventions.Results: Forty patients (39 women; mean age 59 years) met the eligibility criteria; 23 were randomizedto receive SNS and 17 to PTNS. Fifteen patients progressed to permanent SNS implantation and 16received a full course of PTNS. Within-group effect sizes were marginally greater for SNS than forPTNS on available-case analysis. Mean(s.d.) FI episodes per week at baseline, and 3 and 6 months offollow-up were: 11⋅4(12⋅0), 4⋅0(4⋅0) and 4⋅9(6⋅9) respectively for SNS compared with 10⋅6(11⋅2), 5⋅8(6⋅9)and 6⋅3(6⋅9) for PTNS. Mean(s.d.) Cleveland Clinic Incontinence Score values at baseline, and 3 and6 months were: 16⋅2(3⋅0), 11⋅1(5⋅2) and 10⋅4(5⋅6) for SNS versus 15⋅1(2⋅7), 11⋅7(4⋅4) and 12⋅1(5⋅2) forPTNS. Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18patients in the SNS group compared with seven of 15 in the PTNS group. Effect estimates for SNS withchronic implanted stimulation were larger (10 of 15 patients at 6 months). Disease-specic and genericquality-of-life improvements complemented clinical outcome data. Qualitative analysis of interview datasuggested that both treatments had high acceptability amongst patients.Conclusion: In the short term, both SNS and PTNS provide some clinical benet to patientswith FI. Registration numbers: 2010-018728-15 and 10479 (http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10479).

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Global Health and Infection
Research Centres and Groups: Wellcome Trust Brighton and Sussex Centre for Global Health Research
Depositing User: emma louise Bertrand
Date Deposited: 14 Sep 2018 11:36
Last Modified: 02 Jul 2019 14:33
URI: http://sro.sussex.ac.uk/id/eprint/78745

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