Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
NCT ID: NCT04749316
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2017-08-01
2020-12-31
Brief Summary
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Detailed Description
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Conservative management of FI involves lifestyle, medical adjustments and pelvic floor sphincter training. If conservative treatment fails, surgical options such as sphincter repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can be reformed. SNM and PTNS involve application of nervous electrical stimulation (neuromodulation) with significant improvement of symptoms. The positions of electrical stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese Medicine for the treatment of faecal incontinence. However, disadvantage of these methods are; 1) they are invasive and may cause complications such as pain, infection and bleeding and; 2) the devices for each SNM device can be costly.
Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used for the management of pain. It works via the application of electrical stimuli using adhesive gel pads. They are cheap to run and are widely accepted by patients. Hence application of TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.
A randomised controlled trial will be carried out on patients with FI. Demographic data, past medical history, in particular any structural or neurological causes of FI, will be recorded. Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment. Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup intervals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AcuTENS
Patients treated with TENS over Acupuncture points for faecal incontinence
AcuTENS
Stimulation of acupuncture points with TENS machine
Sham
Sham treatment arm with no electrical stimulations over acupuncture points
AcuTENS
Stimulation of acupuncture points with TENS machine
Interventions
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AcuTENS
Stimulation of acupuncture points with TENS machine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
99 Years
ALL
No
Sponsors
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Health and Medical Research Fund
OTHER_GOV
Chinese University of Hong Kong
OTHER
Responsible Party
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Tony Wing Chung Mak
Associate Professor
Principal Investigators
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Tony WC Mak, MD, FRCS
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Other Identifiers
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HMRF13140421
Identifier Type: -
Identifier Source: org_study_id
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