Status:
UNKNOWN
Efficacy of Acupuncture as a Treatment for Faecal Incontinence
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Singapore College of Traditional Chinese Medicine
Conditions:
Faecal Incontinence
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Overall Aim: To improve the long-term management outcomes for faecal incontinence (FI); through the implementation of new alternative treatment to complement existing treatment options, and enable be...
Detailed Description
Experimental design and procedure The study will run as a prospective, multi-centre, randomised controlled trial of patients with faecal incontinence of best medical therapy versus TCM-Acupuncture. P...
Eligibility Criteria
Inclusion
- Patients presenting with faecal incontinence
- At least 2 episodes of faecal incontinence per week, St Mark's incontinence score of 5 or greater
- Patients aged 21 years or older
- Prior colonoscopy done to exclude underlying colonic pathology
- Written informed consent obtained
Exclusion
- Active inflammation of the bowel, including inflammatory bowel disease, infection or perianal sepsis
- Pregnant women
- Current or previous diagnosis of the gastrointestinal tract, genitourinary, or pelvic cancers
- Presence of congenital or acquired neurological deficits (including spinal disorders)
- Previous history of complex major pelvic, anal or rectal surgery
- Previous history of multi-focal or major sphincter injuries or deficits
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04276350
Start Date
February 7 2018
End Date
November 30 2020
Last Update
March 19 2020
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore