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

February 6, 2021 updated by: Tony Wing Chung Mak, Chinese University of Hong Kong

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

This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Time Frame: post treatment 8 weeks and 6 months compared with baseline
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
Time Frame: post treatment 8 weeks and 6 months compared with baseline
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
Time Frame: post treatment 8 weeks and 6 months compared with baseline
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
Time Frame: post treatment 8 weeks and 6 months compared with baseline
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
Time Frame: post treatment 8 weeks and 6 months compared with baseline
using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL)
post treatment 8 weeks and 6 months compared with baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Health and Medical Research Fund

Investigators

  • Principal Investigator: Tony WC Mak, MD, FRCS, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMRF13140421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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