Annals of Surgery

Skip Navigation LinksHome > July 2014 - Volume 260 - Issue 1 > A Randomized, Controlled, Crossover Study of Sacral Nerve St...
Annals of Surgery:
doi: 10.1097/SLA.0000000000000559
Randomized Controlled Trials

A Randomized, Controlled, Crossover Study of Sacral Nerve Stimulation for Irritable Bowel Syndrome

Fassov, Janne L. PhD*,†; Lundby, Lilli PhD*; Laurberg, Søren DMSc*; Buntzen, Steen DMSc*; Krogh, Klaus DMSc

Collapse Box

Abstract

Objective: To investigate whether sacral nerve stimulation reduces irritable bowel syndrome (IBS)-specific symptoms by a randomized, controlled, crossover study.

Background: IBS affects 3% to 22% of the population worldwide, but most patients continue to have symptoms despite treatment.

Methods: Patients included from our tertiary center had diarrhea-predominant or mixed IBS, with a minimum baseline IBS symptom score (Gastrointestinal Syndrome Rating Scale–IBS questionnaire) of 40 points reduced by a minimum of 30% during the percutaneous nerve evaluation before permanent implantation. Patients were randomized (1:1) to have the stimulator ON or OFF for 1 month and then the opposite for another month. Investigators and patients were not informed of the setting. IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires. Primary endpoint was the IBS-specific symptom score.

Results: Twenty-one patients were randomized. Ten were eligible for analysis in each group. IBS-specific symptom scores were significantly reduced during stimulation: the median difference in the ON-OFF group was 12 (range, −22 to 44) and in the OFF-ON group −17.5 (range, −48 to −1) (P = 0.0009). IBS-specific quality-of-life scores improved significantly during stimulation: the median difference in the ON-OFF group was 16 (range, −24 to 69) and in the OFF-ON group −42.5 (range, −77 to 0) (P = 0.0003). At 1-year follow-up, the median IBS-specific symptom score (25; range, 13–65) was significantly lower than that at baseline (62; range, 45–80) (P = 0.0001).

Conclusions: Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS.

© 2014 by Lippincott Williams & Wilkins.

Login

Article Tools

Share

Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.