Faecal Incontinence Clinical Trial
Official title:
Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
Verified date | February 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Status | Completed |
Enrollment | 53 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Chinese University of Hong Kong | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Health and Medical Research Fund |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention | Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham | post treatment 8 weeks and 6 months compared with baseline | |
Secondary | Changes in the severity of faecal incontience | Wexner score will be used the assess the severity of faecal incontinence | post treatment 8 weeks and 6 months compared with baseline | |
Secondary | Episodes of faecal urgency per week | the number of episodes of faecal urgency experienced by the patient per week | post treatment 8 weeks and 6 months compared with baseline | |
Secondary | Reduction in the number of incontinence episode per week | the number of episodes of faecal incontience experienced by the patient per week | post treatment 8 weeks and 6 months compared with baseline | |
Secondary | Differences in Quality of Life score between two groups | using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL) | post treatment 8 weeks and 6 months compared with baseline |
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