Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
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 clinical trial is to evaluate the long-term 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 Aug 2025
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2025
CompletedFirst Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
August 11, 2025
August 1, 2025
7.3 years
August 4, 2025
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Mayo score
The range of Mayo score is 0-12, and higher scores mean worse outcome
From baseline to 8 years
Secondary Outcomes (11)
Clinical remission
From baseline to 8 years
Clinical response
From baseline to 8 years
Change from baseline in the Truelove and Witts Severity Index
From baseline to 8 years
Endoscopic remission
From baseline to 8 years
Fecal calprotectin levels
From baseline to 8 years
- +6 more secondary outcomes
Study Arms (1)
Sacral nerve stimulation
EXPERIMENTALInterventions
Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol
Eligibility Criteria
You may qualify if:
- 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
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)
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
August 4, 2025
First Posted
August 11, 2025
Study Start
August 2, 2025
Primary Completion (Estimated)
December 1, 2032
Study Completion (Estimated)
December 1, 2032
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share