Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
1 other identifier
interventional
15
1 country
1
Brief Summary
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 exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedDecember 4, 2025
April 1, 2025
2.6 years
May 15, 2023
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Mayo score at week 12
Mayo score at 12 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome.
12 weeks
Secondary Outcomes (32)
Change from baseline in the Mayo score at week 24, and 52
24 and 52 weeks
Clinical remission at Week 12, 24, and 52
12, 24, and 52 weeks
Clinical response at Week 12, 24, and 52
12, 24, and 52 weeks
Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52
12, 24, and 52 weeks
Endoscopic remission at Week 12, 24, and 52
12, 24, and 52 weeks
- +27 more secondary outcomes
Study Arms (1)
Sacral nerve stimulation
EXPERIMENTALInterventions
Neuromodulation was performed according to the usual protocol
Eligibility Criteria
You may qualify if:
- age ≥18 years
- ulcerative colitis diagnosed for at least 3 mouths.
- Mayo score 6-12, Mayo endoscopic score 2-3 points
- resistant to medical treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kaichun Wu, PhD
Air Force Military Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
June 9, 2023
Study Start
July 20, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
December 4, 2025
Record last verified: 2025-04