NCT04749316

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

February 2, 2021

Last Update Submit

February 6, 2021

Conditions

Faecal IncontinenceFaecal Incontinence With Faecal UrgencyNeuromodulationTranscutaneous Electric Nerve StimulationAcupuncture Points

Keywords

Faecal incontinenceFaecal urgencyNeuromodulationTranscutaneous Electric Nerve StimulationAcupuncture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in the severity of faecal incontience

    post treatment 8 weeks and 6 months compared with baseline

  • Episodes of faecal urgency per week

    post treatment 8 weeks and 6 months compared with baseline

  • Reduction in the number of incontinence episode per week

    post treatment 8 weeks and 6 months compared with baseline

  • Differences in Quality of Life score between two groups

    post treatment 8 weeks and 6 months compared with baseline

Study Arms (2)

AcuTENS

EXPERIMENTAL

Patients treated with TENS over Acupuncture points for faecal incontinence

Procedure: AcuTENS

Sham

SHAM COMPARATOR

Sham treatment arm with no electrical stimulations over acupuncture points

Procedure: AcuTENS

Interventions

AcuTENSPROCEDURE

Stimulation of acupuncture points with TENS machine

AcuTENSSham

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Tony WC Mak, MD, FRCS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participant will not be told on which treatment arm are in. Outcome assessors will be blinded on participants' treatment arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Acutens treatment for faecal incontinence vs sham
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 11, 2021

Study Start

August 1, 2017

Primary Completion

October 30, 2020

Study Completion

December 31, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)