Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls

Study Overview
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Brief Summary
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This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence

Detailed Description
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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.

Official Title
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Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.

Conditions
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Faecal Incontinence, Faecal Incontinence With Faecal Urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation, Acupuncture Points

Intervention / Treatment
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* Procedure: AcuTENS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Acutens treatment for faecal incontinence vs sham
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcuTENS<br>Patients treated with TENS over Acupuncture points for faecal incontinence | Procedure: AcuTENS<br>* Stimulation of acupuncture points with TENS machine<br>|
| Sham Comparator: Sham<br>Sham treatment arm with no electrical stimulations over acupuncture points | Procedure: AcuTENS<br>* Stimulation of acupuncture points with TENS machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Faecal incontinence, Faecal urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation