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A randomized double-blinded sham-controlled cross-over trial of tined-lead sacral nerve stimulation testing for chronic constipation

Yiannakou, Yana; Etherson, Kevind; Close, Helene; Kasim, Adetayoc; Mercer-Jones, Markh; Plusa, Stefang; Maier, Rebeccaf; Green, Susanb; Cundall, Jeremyb; Knowles, Charlesi; Mason, Jamesj

European Journal of Gastroenterology & Hepatology: June 2019 - Volume 31 - Issue 6 - p 653–660
doi: 10.1097/MEG.0000000000001379
Original Articles: Gastroenterology
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Objectives Sacral nerve stimulation (SNS) may provide long-term symptom relief to patients suffering from chronic constipation. Patients are currently selected for SNS using a 2-week peripheral nerve evaluation (PNE) comprising stimulation by temporary leads. However, only 40% of test responders receive long-term benefit from treatment meaning that healthcare costs per successfully treated patient are too high. The primary objective was to assess tined-lead testing to predict benefit from SNS for chronic constipation.

Patients and methods A randomized double-blind sham-controlled cross-over design evaluated enhanced PNE (ePNE) using tined quadripolar electrode leads over 6 weeks. The design differentiated between patients with discriminate and indiscriminate responses to testing. A score improvement of 25% or more was considered to be a positive response within a stimulation period. The primary outcome was the proportion of patients showing a reduction of at least 0.5 in constipation symptom score at 6 months.

Results A total of 45 patients were randomized, of whom 29 (64.4%) were test-phase responders. Of these, 27 were implanted providing permanent SNS. During ePNE, seven (18%) were discriminate responders, 22 (56%) were indiscriminate responders and 10 (26%) were nonresponders. Six patients were withdrawn during the test phase because of infection or noncompliance. At 6 months, there was no significant difference in primary outcome between discriminate and indiscriminate responders (60 vs. 57%, P=0.76). The study was terminated prematurely because of a persistent infection rate of 10 (22%) during ePNE of which nine (20%) were severe.

Conclusion ePNE is a poor predictor of treatment response at 6 months. This suggests a strong and persistent placebo response during both SNS PNE and treatment. An extended 6-week PNE poses a high risk of infection.

Departments of aNeurogastroenterology

bGeneral and Colorectal Surgery, County Durham and Darlington NHS Foundation Trust

cDurham University, Durham

dDepartment of Colorectal Surgery, North Tees and Hartlepool NHS Foundation Trust, Stockton

eInstitute of Health and Society

fNewcastle Clinical Trials Unit, Newcastle University

gDepartment of Colorectal Surgery, Newcastle University Teaching Hospitals, Newcastle upon Tyne

hDepartment of Colorectal Surgery, Gateshead Health Foundation Trust, Gateshead

iQueen Mary University of London, London

jDepartment of Health Economics, Warwick Medical School, Warwick University, Warwick, UK

Correspondence to Yan Yiannakou, MD, Darlington Memorial Hospital, Hollyhurst Road, Darlington, County Durham, DL3 6HX Durham, UK Tel: +44 191 333 2333; fax: +44 191 333 2685; e-mail: yan.yiannakou@nhs.net

Received May 25, 2018

Accepted July 26, 2018

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.