Irritable Bowel Syndrome Clinical Trial
Official title:
Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
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.
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