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

NCT ID: NCT02748590

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromodulation

Group Type: EXPERIMENTAL

InterStim II Neurostimulator Model 3058

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Active Ulcerative Colitis diagnosed on criteria Lennard Jones (31) for at least 1 year
• > 18 yo
• E1 - E2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures)
• resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-TNF)
• Activity score >5 and endoscopic score >2
• Absence of bacterial infection in progress (Clostridium difficile)
• Affiliated with a social protection scheme and had signed an informed consent

Exclusion Criteria

• Severe forms requiring hospitalization an intravenous treatment or immediate surgery
• infectious colitis or proctitis
• Prednisone> 20 mg / d
• Contraindications to the use of neuromodulator
• Corticosteroid therapy by intravenous route
• Pregnant women
• Major Trust

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

RC15_0448

Identifier Type: -

Identifier Source: org_study_id