Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000736640
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
11/07/2014
Date last updated
16/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the effectiveness of transabdominal electrical stimulation (TES) in the treatment of female adult patients with constipation.
Scientific title
Determining the effectiveness of transabdominal electrical stimulation (TES) in the treatment of female adult patients with constipation
Secondary ID [1] 284896 0
nil
Universal Trial Number (UTN)
Trial acronym
DeTEST constipation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 292355 0
Condition category
Condition code
Oral and Gastrointestinal 292679 292679 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trans abdominal electrical stimulation via an interferential current is applied using 4 electrodes placed on the stomach and back. A supposedly therapeutic current passes diagonally from right front to left back and vice versa. The device has 4kHz carrier frequency, 80-160 Hz beat frequency, intensity <33mA. This is applied for an hour a day for 6 weeks throughout the study period
Intervention code [1] 289711 0
Treatment: Devices
Comparator / control treatment
Sham transabdominal electrical stimulation where an interferential current is used via 4 electrodes, but the current passes from right front to right back, and left front to left back, not providing any therapeutic stimulation. This is applied for an hour a day throughout the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 292522 0
defaecation frequency; assessed via a daily bowel diary using Bristol stool scale to define stool type, recording bowel activity and laxative use
Timepoint [1] 292522 0
daily for 2 weeks pre trial, daily for 1 week mid trial and daily for 2 weeks at end of trial. Also daily for 2 weeks at 3 months post intervention and at one year post intervention.
Secondary outcome [1] 309142 0
faecal soiling; as recorded in a questionnaire that contains the St Mark's incontinence scoring system in combination with 2 other validated questionnaires, the PAC QOL, and the PAC SYM
Timepoint [1] 309142 0
questionnaire completed at 2 weeks prior to study, mid way through study, at the end of study, at 3 months post intervention and at 1 year post intervention
Secondary outcome [2] 309232 0
laxative use; as reported in the bowel diary using the Bristol Stool scale designed specifically to capture daily bowel activity, stool type, and laxative use
Timepoint [2] 309232 0
daily for 2 weeks pre trial, daily for 1 week mid trial and daily for 2 weeks at end of trial. Also daily for 2 weeks at 3 months post intervention and at one year post intervention.
Secondary outcome [3] 309233 0
stool consistency; as reported in the bowel diary using the Bristol Stool scale designed specifically to capture daily bowel activity, define stool type/consistency, and laxative use
Timepoint [3] 309233 0
daily for 2 weeks pre trial, daily for 1 week mid trial and daily for 2 weeks at end of trial. Also daily for 2 weeks at 3 months post intervention and at one year post intervention.
Secondary outcome [4] 309234 0
quality of life; as assessed by completing the PAC-QOL component of the study questionnaire, that also contains the PAC-SYM and St Mark's incontinence scoring system
Timepoint [4] 309234 0
questionnaire completed at 2 weeks prior to study, mid way through study, at the end of study, at 3 months post intervention and at 1 year post intervention
Secondary outcome [5] 309235 0
anorectal physiology; assessed via pull through anal manometry assessing resting tone and anal squeeze pressure as well as assessing threshold volume, defaecatory desire volume and maximal tolerable volume via distension of a latex balloon to a maximum of 360mls
Timepoint [5] 309235 0
pre study and 6 weeks; the end of intervention
Secondary outcome [6] 309236 0
colon transit time study: assessed via plain abdominal x-ray 5 days after swallowing a capsule containing inert markers, to assess transit time of these markers through the bowel.
Timepoint [6] 309236 0
pre study and at 6 weeks; the end of intervention

Eligibility
Key inclusion criteria
bowel actions less than or equal to twice a week and hard stools, or difficulty passing or sense of incomplete evacuation 25% of the time
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
constipation secondary to medication, neurological or metabolic disorders; megacolon; previous surgery to colon,
organic disorders of the bowel
medications causing constipation
pregnancy
serious co morbidities
unable to give informed consent/non english speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
prospective participants will undergo consultation and physical exam with study doctor, using a checklist for inclusion criteria. Those consenting will undergo anorectal physiology studies and transit colon study prior to randomisation via an envelope containing which treatment to be received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a computer generated list will randomly allocate each patient to treatment A or B
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/08/2014
Actual
30/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2691 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8394 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 289518 0
University
Name [1] 289518 0
Monash University
Country [1] 289518 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Faculty of Medicine, Nursing and Health Sciences
level 6, The Alfred Centre
99 Commercial Rd
Prahan,Vic. 3181
Country
Australia
Secondary sponsor category [1] 288206 0
None
Name [1] 288206 0
Address [1] 288206 0
Country [1] 288206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291263 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 291263 0
55 Commercial Rd
Prahan
Victoria 3181
Ethics committee country [1] 291263 0
Australia
Date submitted for ethics approval [1] 291263 0
02/07/2014
Approval date [1] 291263 0
04/08/2014
Ethics approval number [1] 291263 0
282/14

Summary
Brief summary
This study is investigating the ability of a means of gentle electrical stimulation to the abdomen in improving bowel function in patients with constipation. This is called trans abdominal electrical stimulation (TES). It is used successfully in the treatment of urinary incontinence, but a side effect is diarrhoea. It has been used in a study on children with constipation where it improved bowel function and quality of life. We believe it will also improve bowel function in adults with constipation. This stimulation is administered through 4 sticky electrodes where 2 are on the front of the abdomen and 2 on the back. The current passes diagonally through from front to back on both sides. We will split participants into two groups where one receives the stimulation the correct way, and the other where the current does not go diagonally, but from right front to right back, the same on the left. It is believed this is not therapeutic. Participants will not know which way is the correct way, so we hope that those who do receive it the correct way will show an improvement over those that don’t. The study will run for 6 weeks for each participant. Participants will keep a diary and answer a questionnaire before, halfway through and at the end of the study. Further contact for this information will also be at 3 months and one year after the study. Before and after the study tests on the function of the rectum and anus will be done, as will a colon transit time study, which looks at how quickly the colon works.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49590 0
Dr Rebecca Burgell
Address 49590 0
Monash university,
level 6, The Alfred Centre
99 Commercial Rd
Prahan
Vic 3181
Country 49590 0
Australia
Phone 49590 0
+61 3 99030609
Fax 49590 0
Email 49590 0
[email protected]
Contact person for public queries
Name 49591 0
Judy Moore
Address 49591 0
Monash university,
level 6, The Alfred Centre
99 Commercial Rd
Prahan
Vic 3181
Country 49591 0
Australia
Phone 49591 0
+61 3 99030233
Fax 49591 0
Email 49591 0
[email protected]
Contact person for scientific queries
Name 49592 0
Peter Gibson
Address 49592 0
Monash university,
level 6, The Alfred Centre
99 Commercial Rd
Prahan
Vic 3181
Country 49592 0
Australia
Phone 49592 0
+61 3 90763325
Fax 49592 0
Email 49592 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
SourceTitleYear of PublicationDOI
EmbaseRandomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation.2020https://dx.doi.org/10.1111/apt.15642
N.B. These documents automatically identified may not have been verified by the study sponsor.