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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

doi: 10.1097/SLA.0000000000000559
Randomized Controlled Trials

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.

With this randomized, controlled, crossover study, we have found sacral nerve stimulation to significantly reduce irritable bowel syndrome (IBS)-specific symptoms and improve IBS-specific quality of life in highly selected patients with diarrhea-predominant or mixed IBS. The effects were seen persisting at 1-year follow-up.

*Department of Surgery P

Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.

Reprints: Janne Fassov, PhD, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark. E-mail:

Disclosure: Supported by a grant from The Danish Council for Strategic Research. Neurostimulators used in the study were provided free of charge by Medtronic Inc. Medtronic Inc had no influence on study design, data analysis, or interpretation, writing, or submission of the report. Lilli Lundby and Steen Buntzen have received honoraria from Medtronic Inc as speakers. Søren Laurberg has received an honorarium as a member of the Medtronic Inc Medical Advisory Board. Janne Fassov and Klaus Krogh have nothing to disclose.

© 2014 by Lippincott Williams & Wilkins.