NCT02748590

Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)

Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

Detailed description

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.

Conditions

• Active Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	InterStim II Neurostimulator Model 3058	The neuromodulation will be carried out according to the usual protocol: Hospitalization for the establishment of percutaneous electrode in the operating room under general anesthesia with fluoroscopic control. The pacemaker startup will be performed within 12h after surgery

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-04-22
• Last updated: 2020-04-01

Locations

1 site across 1 country: France