Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacral nerve stimulation.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
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
Interventions
- Device Sacral nerve stimulation
Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol
Primary outcome measures
- Change from baseline in the Mayo score [Time frame: From baseline to 8 years]
Secondary outcome measures (11)
- Clinical remission [Time frame: From baseline to 8 years]
- Clinical response [Time frame: From baseline to 8 years]
- Change from baseline in the Truelove and Witts Severity Index [Time frame: From baseline to 8 years]
- Endoscopic remission [Time frame: From baseline to 8 years]
- Fecal calprotectin levels [Time frame: From baseline to 8 years]
- erythrocyte sedimentation rate levels [Time frame: From baseline to 8 years]
- C reactive protein levels [Time frame: From baseline to 8 years]
- Inflammatory Bowel Disease Questionnaire Score [Time frame: From baseline to 8 years]
- Hospital Anxiety and Depression scale score [Time frame: From baseline to 8 years]
- Gut microbiota profile [Time frame: From baseline to 8 years]
- The Pittsburgh Sleep Quality Index [Time frame: From baseline to 8 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xijing Hospital — Xi'an
Identifiers
NCT: NCT07114159 · KY20232100-extension