Browse by author
Lookup NU author(s): Professor Yan Yiannakou, Kevin Etherson, Dr Helen Close, Stefan Plusa, Rebecca Maier
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
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 Six patients were withdrawn during the test phase because of infection or noncompliance.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.
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
Altmetrics provided by Altmetric