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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02748590
• Date of registration: 14/04/2016
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM) PRIMICISTIM
• Scientific title: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
• Date of first enrolment: June 2016
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02748590
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Active Ulcerative Colitis

Intervention(s)

Device: InterStim II Neurostimulator Model 3058

Primary Outcome(s)

Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score) [Time Frame: 8 weeks]

Secondary Outcome(s)

Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index) [Time Frame: 16 weeks]

Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index) [Time Frame: 16 weeks]

Evaluate the immunosuppressive drugs at Week 8 and Week 16 [Time Frame: 16 weeks]

Evaluate the need for steroids at Week 8 and Week 16 [Time Frame: 16 weeks]

Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index) [Time Frame: 16 weeks]

Assess the Remission at Week 16 ( Mayo score) [Time Frame: 16 weeks]

Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index) [Time Frame: 16 weeks]

Assess the biological response at Week 8 and Week 16 (C-reactive protein) [Time Frame: 16 weeks]

Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index) [Time Frame: 16 weeks]

Assess abdominal discomfort for weeks at Week 8 and Week 16 [Time Frame: 16 weeks]

Assess the histological response at Week 8 and Week 16 (Geboes Score) [Time Frame: 16 weeks]

Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36) [Time Frame: 16 weeks]

Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16 [Time Frame: 16 weeks]

Assess the biological response at Week 8 and Week 16 (Calprotectin) [Time Frame: 16 weeks]

Evaluate the cessation of rectal bleeding at Week 8, Week 16 [Time Frame: 16 weeks]

Secondary ID(s)

RC15_0448

Source(s) of Monetary Support

Please refer to primary and secondary sponsors