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Trial registered on ANZCTR


Registration number
ACTRN12617000727347
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
18/05/2017
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the use of a containment product for the treatment of faecal incontinence (IFI) in stroke survivors versus standard faecal incontinence (FI) care in a rehabilitation setting.
Scientific title
A containment strategy using anal plugs for the treatment of intractable faecal incontinence (IFI) in stroke survivors versus standard FI care in a rehabilitation setting: a feasibility study.
Secondary ID [1] 291910 0
Nil known
Universal Trial Number (UTN)
U1111-1196-1946
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Intractable faecal incontinence 303078 0
Stroke 303079 0
Condition category
Condition code
Stroke 302537 302537 0 0
Ischaemic
Stroke 302654 302654 0 0
Haemorrhagic
Oral and Gastrointestinal 302686 302686 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
Randomised Controlled Trial whereby the study participants are randomised to one of two groups. Randomisation will occur at patient level at Bentley Hospital site. The experimental group will be provided with the use of the Coloplast PERISTEEN Registered trademark anal plug in addition to usual care and the comparison control group will receive the usual rehabilitation FI care provided by the rehabilitation unit (excluding the use of the anal plug). The sample population are stroke survivor patients who are receiving care in a rehabilitation unit. The sample population have intractable faecal incontinence (IFI). The anal plug will be inserted with assistance on day one from the nurse. The nurse will assist the primary caregiver in the use of the anal plug at that point in time. Nursing shifts are 12 hour shifts. The staff member responsible for the patient will check the plug at the commencement of each shift (two) per day and will complete the Bristol Stool chart (BSC) for that patient at each shift. BSC data will be collected over a two week period (14 days ).
The Peristeen Anal Plug is inserted like a suppository due to compression of the foam by outer film which then dissolves once inside the rectum. The anal plug I easily removed after a maximum of 12 hours using the gauze string attached to the plug. For this study, the plugs will be inserted twice in 24 hour period ( 1 per 12 hours) for 14 days.
Intervention code [1] 297946 0
Treatment: Devices
Comparator / control treatment
Usual standard care is defined as assistance provided to maintain continence by ward nursing staff (but not use of the plug) with referral to a continence nurse if felt to be clinically indicated.
Control group
Active

Outcomes
Primary outcome [1] 301961 0
The primary outcome of the study is to determine the proportion of days free from FI from commencement of trial following the four day introduction period to use of Coloplast PERISTEEN.
Timepoint [1] 301961 0
The primary endpoint will be assessed 14 days after commencement of trial. Baseline data collection will occur on the initial day when the anal plug is introduced.
Secondary outcome [1] 334379 0
Satisfaction with management of FI by both groups pre intervention and post intervention.
Measurement: The satisfaction survey – is designed specifically for this study by the research team with a separate questionnaire for the patient and the primary caregiver. To be completed by both patients and carers.

Initial day of anal plug usage and again 14 days hence.

Timepoint [1] 334379 0
Commencement of trial period (following from 4 day introduction period) and at the end of the two week trial period (14 days).
Secondary outcome [2] 334380 0
Quality of life of carers (family)
Measurement: The Health in Aging Caregiver Self-assessment questionnaire, This questionnaire was originally developed and tested by the American Medical Association copyright 2015 Health in Aging Foundation.
Timepoint [2] 334380 0
Commencement of trial period (following from 4 day introduction period) and at the end of the two week trial period (14 days).
Secondary outcome [3] 334381 0
Number of instances of pseudo-continence (continence only whilst wearing plug = intervention group).
Measurements:
Revised Faecal Incontinence Score (RFIS) counts the episodes of continence whilst wearing the plug and will also be documented in the Bristol Stool Chart.
Timepoint [3] 334381 0
We will be measuring from day 1 baseline and for each day up until and including Day 14 .
Secondary outcome [4] 334383 0
Quality of life of patient
Measurement:
The Faecal Incontinence quality of life scale (Wexner Scale)
Timepoint [4] 334383 0
The Wexner scale will be administered at baseline (Day 1) and again on Day 14.
Secondary outcome [5] 334716 0
Feasibillity of use of anal plug using the Wexner scale.
Timepoint [5] 334716 0
We will assess feasibility by recording recruitment rates (proportion of screened) and proportion of recruited patients / carer dyads.

Eligibility
Key inclusion criteria
Eligibility criteria for the study is as follows:
Ischemic or haemorrhagic stroke with clinical diagnosis using NIH stroke scale
Adult (over 25 years)
Persistent faecal incontinence as defined by Norton et al (2010)
At least one week post stroke
Both groups will have been assessed by the Continence Nurse Specialist as having already received an assessment from a clinician which includes an abdominal assessments and per rectal examination.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Faecal impaction or constipation using modified ROME diagnostic criteria for functional constipation
Incontinence caused by infective agent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
11/11/2017
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7915 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 15876 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 296330 0
University
Name [1] 296330 0
University of Notre Dame
Country [1] 296330 0
Australia
Funding source category [2] 296335 0
Commercial sector/Industry
Name [2] 296335 0
Coloplast Peristeen
Country [2] 296335 0
Australia
Primary sponsor type
University
Name
University of Notre Dame
Address
19, Mouat Street, Fremantle 6959 WA
Country
Australia
Secondary sponsor category [1] 295258 0
Commercial sector/Industry
Name [1] 295258 0
Coloplast Peristeen
Address [1] 295258 0
Coloplast Australia,
Level 4, 1 Acacia Place
Ferntree Business Park,
Nottinghill 3168
Vic
Country [1] 295258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297560 0
The University of Notre Dame Australia
Ethics committee address [1] 297560 0
Ethics committee country [1] 297560 0
Australia
Date submitted for ethics approval [1] 297560 0
21/11/2016
Approval date [1] 297560 0
29/12/2016
Ethics approval number [1] 297560 0
016178F
Ethics committee name [2] 297565 0
East Metropolitan Health Research Ethics Committee
Ethics committee address [2] 297565 0
Ethics committee country [2] 297565 0
Australia
Date submitted for ethics approval [2] 297565 0
19/09/2016
Approval date [2] 297565 0
23/12/2016
Ethics approval number [2] 297565 0
2016-221

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1684 1684 0 0
/AnzctrAttachments/372846-RPH HREC 2016-221 Final Approval.pdf (Ethics approval)
Attachments [2] 1685 1685 0 0
/AnzctrAttachments/372846-Approval Unconditional Caroline Bulsara 016178F.pdf (Ethics approval)
Attachments [3] 1686 1686 0 0
/AnzctrAttachments/372846-RFISBrochure.pdf (Other)
Attachments [4] 1687 1687 0 0
/AnzctrAttachments/372846-PATIENT SATISFACTION SURVEY.pdf (Other)
Attachments [5] 1688 1688 0 0
/AnzctrAttachments/372846-caregiver.self_assessment.pdf (Other)
Attachments [6] 1689 1689 0 0
/AnzctrAttachments/372846-CARER SATISFACTION SURVEY.pdf (Other)
Attachments [7] 1691 1691 0 0
/AnzctrAttachments/372846-PICF Interventional for Self Patient Version 1 0 03Oct2016 -tracked changes accepted Nov 2016.doc (Participant information/consent)
Attachments [8] 1693 1693 0 0
/AnzctrAttachments/372846-PICF Interventional for Self_carer_FINAL_tracked changes accepted CBulsara Nov 2016.doc (Participant information/consent)

Contacts
Principal investigator
Name 74442 0
Mrs Simone Quartemaine
Address 74442 0
Bentley Health Service,
Mills Street
Bentley WA 6102
Country 74442 0
Australia
Phone 74442 0
+61 8 9416 3749
Fax 74442 0
Email 74442 0
simone.quartermaine@wa.health.gov.au
Contact person for public queries
Name 74443 0
Caroline Bulsara
Address 74443 0
Institute for Health Research, The University of Notre Dame (Fremantle)
19, Mouat Street,
Fremantle 6959 WA
Country 74443 0
Australia
Phone 74443 0
+61 8 9433 0217
Fax 74443 0
Email 74443 0
caroline.bulsara@nd.edu.au
Contact person for scientific queries
Name 74444 0
Caroline Bulsara
Address 74444 0
University of Notre Dame, 19 Mouat Street
Fremantle 6959 WA
Country 74444 0
Australia
Phone 74444 0
+61 8 9433 0217
Fax 74444 0
Email 74444 0
caroline.bulsara@nd.edu.au

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.