An interventional study of AcuTENS in Faecal Incontinence, Faecal Incontinence With Faecal Urgency and Neuromodulation, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 53 is close to the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with TENS over Acupuncture points for faecal incontinence
Procedure: AcuTENS
Sham treatment arm with no electrical stimulations over acupuncture points
Procedure: AcuTENS
Stimulation of acupuncture points with TENS machine
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
Time frame: post treatment 8 weeks and 6 months compared with baseline
Changes in the severity of faecal incontience
Wexner score will be used the assess the severity of faecal incontinence
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: post treatment 8 weeks and 6 months compared with baseline
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong