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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Device: Sacral nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07114159

KY20232100-extension

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Sacral nerve stimulation

Experimental group

Treatment:

Device: Sacral nerve stimulation