Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis

Xijing Hospital15 enrolled

Overview

Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents. The aim of this clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Sacral nerve stimulationDEVICE

Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18-65 years * ulcerative colitis diagnosed for at least 3 mouths. * Mayo score 6-12, Mayo endoscopic score 2-3 points * resistant to medical treatment Exclusion Criteria: * Treatment-naive ulcerative colitis (no previous treatment) * Acute severe ulcerative colitis * Currently taking any biologicals * Previous surgical treatment or severe colitis at imminent risk of surgery * infective colitis * Other systemic diseases * Pregnancy and lactation

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING