Clinical trial NCT04749316: Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Official title: Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faecal Incontinence
Faecal Incontinence With Faecal Urgency
Neuromodulation
Transcutaneous Electric Nerve Stimulation
Acupuncture Points
Keywords: Faecal incontinence
Faecal urgency
Neuromodulation
Transcutaneous Electric Nerve Stimulation
Acupuncture
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2021-02-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Acutens treatment for faecal incontinence vs sham
Primary purpose: TREATMENT

Brief summary: This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
timeFrame: post treatment 8 weeks and 6 months compared with baseline
Secondary outcomes:
measure: Changes in the severity of faecal incontience
timeFrame: post treatment 8 weeks and 6 months compared with baseline
measure: Episodes of faecal urgency per week
timeFrame: post treatment 8 weeks and 6 months compared with baseline
measure: Reduction in the number of incontinence episode per week
timeFrame: post treatment 8 weeks and 6 months compared with baseline
measure: Differences in Quality of Life score between two groups
timeFrame: post treatment 8 weeks and 6 months compared with baseline
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Tony WC Mak, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: