Clinical trial NCT02748590: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)
Official title: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Ulcerative Colitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
timeFrame: 8 weeks
Secondary outcomes:
measure: Assess the Remission at Week 16 ( Mayo score)
timeFrame: 16 weeks
measure: Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
timeFrame: 16 weeks
measure: Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
timeFrame: 16 weeks
measure: Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
timeFrame: 16 weeks
measure: Assess the histological response at Week 8 and Week 16 (Geboes Score)
timeFrame: 16 weeks
measure: Assess the biological response at Week 8 and Week 16 (C-reactive protein)
timeFrame: 16 weeks
measure: Assess the biological response at Week 8 and Week 16 (Calprotectin)
timeFrame: 16 weeks
measure: Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
timeFrame: 16 weeks
measure: Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
timeFrame: 16 weeks
measure: Evaluate the cessation of rectal bleeding at Week 8, Week 16
timeFrame: 16 weeks
measure: Evaluate the immunosuppressive drugs at Week 8 and Week 16
timeFrame: 16 weeks
measure: Evaluate the need for steroids at Week 8 and Week 16
timeFrame: 16 weeks
measure: Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16
timeFrame: 16 weeks
measure: Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36)
timeFrame: 16 weeks
measure: Assess abdominal discomfort for weeks at Week 8 and Week 16
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: