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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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