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A randomised double-blinded sham controlled cross-over trial of tined lead sacral nerve stimulation testing for chronic constipation
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Yiannakou, Yan , Etherson, Kevin , Close, Helen, Kasim, Adetayo, Mercer-Jones, Mark, Plusa, Stefan, Maier, Rebecca, Green, Susan, Cundall, Jeremy, Knowles, Charles and Mason, James (2019) A randomised double-blinded sham controlled cross-over trial of tined lead sacral nerve stimulation testing for chronic constipation. European Journal of Gastroenterology & Hepatology, 31 (6). pp. 653-660. doi:10.1097/MEG.0000000000001379 ISSN 0954-982X.
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Official URL: https://doi.org/10.1097/MEG.0000000000001379
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 Six patients were withdrawn during the test phase because of infection or noncompliance.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.
| Item Type: | Journal Article | ||||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | European Journal of Gastroenterology & Hepatology | ||||||||
| Publisher: | Lippincott, Williams & Wilkins | ||||||||
| ISSN: | 0954-982X | ||||||||
| Official Date: | June 2019 | ||||||||
| Dates: |
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| Volume: | 31 | ||||||||
| Number: | 6 | ||||||||
| Page Range: | pp. 653-660 | ||||||||
| DOI: | 10.1097/MEG.0000000000001379 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Reuse Statement (publisher, data, author rights): | This is a non-final version of an article published in final form in European Journal of Gastroenterology & Hepatology | ||||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||||
| Date of first compliant deposit: | 9 August 2018 | ||||||||
| Date of first compliant Open Access: | 11 February 2020 | ||||||||
| Related URLs: |
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