Active Ulcerative Colitis Clinical Trial
Official title:
Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this
original approach has been confirmed by several studies. New indications for this
minimally-invasive procedure are actually under evaluation particularly in the fields of
irritable bowel syndrome and chronic constipation with promising results. Its mechanism of
action remains partially unknown and the target of neuromodulation is not limited to the anal
sphincter but the whole colonic motility seems to be influenced by this therapeutic approach.
Moreover, recent experimental studies have shown that neuromodulation was able to reinforce
the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis.
Subsequently, preliminary results in human have shown improvement of inflammation in patients
suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical
therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several
patients are suffering from disabling chronic active disease. In those cases of refractory
diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery.
This approach is a curative option, but leads to a significant morbidity and frequent
functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases).
Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be
unadapted and many patients remain symptomatic and suffer chronic active disease.
The aim of this study will be to assess in a prospective pilot study the efficacy of
ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to
the left side of the colon and improving the quality of life of the patients.
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