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

Lookup NU author(s): Professor Yan Yiannakou, Kevin Etherson, Dr Helen Close, Stefan Plusa, Rebecca Maier

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Abstract

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 Six patients were withdrawn during the test phase because of infection or noncompliance.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.


Publication metadata

Author(s): Yiannakou Y, Etherson K, Close H, Kasim A, Mercer-Jones M, Plusa S, Maier R, Green S, Cundall J, Knowles C, Mason J

Publication type: Article

Publication status: Published

Journal: European journal of gastroenterology & hepatology

Year: 2019

Volume: 31

Issue: 6

Pages: 653-660

Online publication date: 01/06/2019

Acceptance date: 02/04/2016

ISSN (print): 0954-691X

Publisher: NLM (Medline)

URL: https://doi.org/10.1097/MEG.0000000000001379

DOI: 10.1097/MEG.0000000000001379

PubMed id: 31009400


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