ANZCTR - Registration

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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]

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Oral and Gastrointestinal

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]

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]

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]

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]

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]

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]

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]

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]

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]

We will be measuring from day 1 baseline and for each day up until and including Day 14 .

Secondary outcome [4]

Quality of life of patient
Measurement:
The Faecal Incontinence quality of life scale (Wexner Scale)

Timepoint [4]

The Wexner scale will be administered at baseline (Day 1) and again on Day 14.

Secondary outcome [5]

Feasibillity of use of anal plug using the Wexner scale.

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Bentley Health Service - Bentley

Recruitment postcode(s) [1]

6102 - Bentley

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Notre Dame

Address [1]

19, Mouat Street, Fremantle 6959 WA.

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Coloplast Peristeen

Address [2]

Coloplast Australia,
Level 4, 1 Acacia Place
Ferntree Business Park,
Nottinghill 3168
Vic

Country [2]

Australia

Primary sponsor type

University

Name

University of Notre Dame

Address

19, Mouat Street, Fremantle 6959 WA

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Coloplast Peristeen

Address [1]

Coloplast Australia,
Level 4, 1 Acacia Place
Ferntree Business Park,
Nottinghill 3168
Vic

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Notre Dame Australia

Ethics committee address [1]

19, Mouat Street Fremantle 6959 WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2016

Approval date [1]

29/12/2016

Ethics approval number [1]

016178F

Ethics committee name [2]

East Metropolitan Health Research Ethics Committee

Ethics committee address [2]

Royal Street, East Perth, WA 6000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/09/2016

Approval date [2]

23/12/2016

Ethics approval number [2]

2016-221

Summary

Brief summary

The study will examine the feasibility, usefulness and acceptability of using the anal plug Coloplast PERISTEEN amongst stroke survivors with persistent Intractable Faecal Incontinence (IFI) during the rehabilitation phase. Patients from Bentley rehabilitation hospital will be recruited to the study and their primary carer over a period twelve months. The use of the anal plug will be compared to the usual care during this phase using a number of validated tools. In addition, both patients and carers will be asked to participate by completing a pre and post satisfaction survey which will also include a quality of life measure.

Trial website

Trial related presentations / publications

Public notes