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Randomized clinical trial of sacral nerve stimulation for refractory constipation
F Zerbib1, L Siproudhis2, P-A Lehur3
1Department of Gastroenterology, Bordeaux University Hospital, and Université de Bordeaux and Institut National de la Santé et de la Recherche Médicale (INSERM) CIC 1401, Bordeaux, France.
The British Journal of Surgery
|October 26, 2016
Summary
Sacral nerve stimulation for refractory constipation showed no significant difference between active and sham treatments in a randomized trial. Permanent implantation is not supported for patients who initially respond to temporary nerve stimulation.
Area of Science:
- Gastroenterology
- Neurology
- Medical Devices
Background:
- Open studies suggest sacral nerve stimulation (SNS) is effective for refractory constipation.
- This study aimed to rigorously assess SNS efficacy in a double-blind, randomized controlled trial (RCT).
Purpose of the Study:
- To evaluate the efficacy of sacral nerve stimulation in patients with refractory constipation.
- To compare active sacral nerve stimulation against sham stimulation in a crossover design.
Main Methods:
- Included patients with fewer than three bowel movements/week, straining >25%, or incomplete evacuation >25%.
- Response defined as ≥3 bowel movements/week or >50% symptom improvement.
- A double-blind crossover RCT involved two 8-week periods of active or sham stimulation, followed by 1 year of active stimulation.
Main Results:
- Twenty of 36 patients responded to initial evaluation and received a permanent stimulator.
- No significant difference in response rates between active (12/20) and sham (11/20) stimulation (P=0.746).
- At 1 year, 11/20 patients with implanted devices continued to respond; stimulation did not significantly affect colonic transit time.
Conclusions:
- The study does not support recommending permanent sacral nerve stimulator implantation for refractory constipation after initial positive response to temporary stimulation.
- Further research may be needed to identify patient subgroups who benefit long-term from sacral nerve stimulation.
