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

Nantes University Hospital8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Active Ulcerative Colitis

Interventions

InterStim II Neurostimulator Model 3058DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)

Clinical and endoscopic remission as measured by the Mayo score ≤ 2 points without any criteria\> 1 point to week 8

Time frame: 8 weeks

Secondary Outcomes

Assess the Remission at Week 16 ( Mayo score)

Remission is defined by a Mayo score ≤ 1 point.

Time frame: 16 weeks

Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)

The response is defined as a decrease of at least 1 point in the item assessment by the physician and at least 1 point from the 3 other items with no increase in the other dimensions of the score.

Time frame: 16 weeks

Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)

The answer Clinic is defined as a decrease of at least 3 points in the score Clinic dimension compared to baseline.

Time frame: 16 weeks

Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)

Endoscopic response corresponds to a decrease of at least 1 point in the endoscopic score

Time frame: 16 weeks

Assess the histological response at Week 8 and Week 16 (Geboes Score)

Mucosal healing is defined by a score of Geboes less than or equal to 1 of the biopsy examination

Time frame: 16 weeks

Assess the biological response at Week 8 and Week 16 (C-reactive protein)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.