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| Name | Class |
|---|---|
| Health and Medical Research Fund | OTHER_GOV |
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This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
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 by patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcuTENS | Experimental | Patients treated with TENS over Acupuncture points for faecal incontinence |
|
| Sham | Sham Comparator | Sham treatment arm with no electrical stimulations over acupuncture points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcuTENS | Procedure | Stimulation of acupuncture points with TENS machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Episodes of faecal urgency per week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony WC Mak, MD, FRCS | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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Acutens treatment for faecal incontinence vs sham
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participant will not be told on which treatment arm are in. Outcome assessors will be blinded on participants' treatment arm.
the number of episodes of faecal urgency experienced by the patient per week
| post treatment 8 weeks and 6 months compared with baseline |
| 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 |
| 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 |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |