A randomized, controlled, crossover study of sacral nerve stimulation for irritable bowel syndrome.

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.