Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls (NCT04749316) | Clinical Trial Compass
CompletedNot Applicable
Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Hong Kong53 participantsStarted 2017-08-01
Plain-language summary
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Timeframe: post treatment 8 weeks and 6 months compared with baseline