A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties. The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study. Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period. During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
The stimulation is set to 90% of the sensory threshold.
The stimulation is turned OFF.
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, Denmark
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
The questionnaire is filled in every week of the 12 week study period
Time frame: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
Irritable Bowel Syndrome - Impact Scale questionnaire
The questionnaire is filled in every week of the 12 week study period
Time frame: Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study
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