Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000321549
Ethics application status
Not yet submitted
Date submitted
17/07/2006
Date registered
26/07/2006
Date last updated
26/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
TENS for faecal incontinence.
Scientific title
Transcutaneous electrical nerve stimulation (TENS) to enhance the anal tone in patients with faecal incontinence.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal Incontinence 1291 0
Condition category
Condition code
Oral and Gastrointestinal 1381 1381 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ranscutaneous electrical nerve stimulation (TENS) - treatment will involve electrodes placed over the lower back for two hours daily, for three months.
Intervention code [1] 1207 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1885 0
The effect of TENS on Faecal Incontinence objective measures - a comparison of pre-intervention and 3 months post-intervention
Timepoint [1] 1885 0
Secondary outcome [1] 3325 0
The effect of TENS on a Faecal Incontinence Quality of Life measure.
Timepoint [1] 3325 0
A comparison of pre-intervention and 3 months post-intervention.

Eligibility
Key inclusion criteria
Signed informed consent; Wexner Score >10; Intact anal sphincters; Neurogenic Incontinence; Failed medical therapy; Compliant with questionnaires and attendance at clinics.
Minimum age
20 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital anorectal malformations; Rectal surgery done <12 months ago (<24 months for cancer); Present external rectal prolapse; Chronic bowel diseases (e.g. IBD); Chronic diarrhoea, unmanageable by diet or drugs; Neurological diseases (e.g. diabetic neuropathy, multiple sclerosis or Parkinson’s disease); Pregnancy; Anatomical limitations preventing placement of an electrode; Skin disease risking infection (e.g. pyoderma, pilonidal sinus); Psychiatric or physical inability to comply with the study protocol; Patients with a poor understanding of English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1515 0
Government body
Name [1] 1515 0
Sydney West Area Health Service
Country [1] 1515 0
Australia
Primary sponsor type
Individual
Name
Dr Simon Chew
Address
Country
Secondary sponsor category [1] 1330 0
Individual
Name [1] 1330 0
Dr S Raj Sundaraj
Address [1] 1330 0
Country [1] 1330 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2938 0
Sydney West Area Health Service - Nepean Campus
Ethics committee address [1] 2938 0
Ethics committee country [1] 2938 0
Australia
Date submitted for ethics approval [1] 2938 0
Approval date [1] 2938 0
Ethics approval number [1] 2938 0

Summary
Brief summary
TENS is a therapeutic non-invasive modality mainly used for pain relief by electrically stimulating nerves via skin surface electrodes. TENS with electrodes over the lower back have also been used successfully to treat the overactive bladder to improve frequency and urgency of urination in patients.
The association of treatment for faecal incontinence and urinary incontinence is evident in Sacral Nerve Stimulation (SNS). Based on clinical observation of effect of stimulation on the function of the anus and rectum in urology patients, SNS has been applied in patients with faecal incontinence. The concept is to enhance the activity of the anal muscles via the electrical stimulation of their nerve supply. The usefulness of SNS in faecal incontinence has been confirmed in a number of studies. However, SNS is an invasive procedure. It requires surgery under general anaesthesia to implant a permanent impulse generator under the skin. TENS with electrodes stimulating the same sacral nerves may result in similar benefits.
Our hypothesis is that the use of TENS in patients with faecal incontinence may have a therapeutic effect. The advantage of this technique is that it is non-invasive, simple, and cost-effective and has minimal side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35488 0
Address 35488 0
Country 35488 0
Phone 35488 0
Fax 35488 0
Email 35488 0
Contact person for public queries
Name 10396 0
Miss Lisa Vaccaro
Address 10396 0
Department of Surgery
Nepean Hospital
Level 5 South Block
PO BOX 63
Penrith NSW 2751
Country 10396 0
Australia
Phone 10396 0
+61 2 47342676
Fax 10396 0
+61 2 47343432
Email 10396 0
[email protected]
Contact person for scientific queries
Name 1324 0
Dr Simon Chew MBBS FRACS
Address 1324 0
Department of Surgery
Nepean Hospital
Level 5 South Block
PO BOX 63
Penrith NSW 2751
Country 1324 0
Australia
Phone 1324 0
+61 2 47343136
Fax 1324 0
+61 2 47343432
Email 1324 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.