Status:
COMPLETED
Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Health and Medical Research Fund
Conditions:
Faecal Incontinence
Faecal Incontinence With Faecal Urgency
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Detailed Description
Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum. Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is under-reported b...
Eligibility Criteria
Inclusion
- Patients aged 18 years or above
- Acupuncture naïve patients
- Faecal incontinence with solid or liquid stool causing disruption of lifestyle
- Psychological stability and suitability as determined by the investigator
- Failed conservative or surgical treatment
- Intact peripheral neurosensory nervous system as determined by clinical investigation
- Able to read and write
Exclusion
- Major internal and/or external sphincter defect (\>120 degrees of sphincter circumference)
- Faecal impaction
- Presence of full thickness rectal prolapse
- Patients who have contact allergies to adhesive pads
- Implanted pacemaker, defibrillator, cardiopathy
- Pregnancy or intention to become pregnant
- Neurogenic or congenital disorders resulting in faecal incontinence (e.g. Multiple Sclerosis, uncontrolled diabetes, Parkinson's disease, Spina Bifida)
- Inflammatory bowel disease
- Chronic diarrhoea uncontrolled by medication or diet
- Previous rectal surgery (rectopexy or rectal resection)
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04749316
Start Date
August 1 2017
End Date
December 31 2020
Last Update
February 11 2021
Active Locations (1)
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1
Chinese University of Hong Kong
Shatin, Hong Kong