Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000879864
Ethics application status
Approved
Date submitted
9/05/2021
Date registered
7/07/2021
Date last updated
28/06/2023
Date data sharing statement initially provided
7/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Study of Adjunct Transcutaneous Electric Stimulation in Post-stroke Incontinence Rehabilitation
Scientific title
A Feasibility Study of Adjunct Transcutaneous Electric Stimulation in Post-stroke Incontinence Rehabilitation
Secondary ID [1] 304178 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
NIl
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Stroke 321870 0
Incontinence 321871 0
Condition category
Condition code
Stroke 319596 319596 0 0
Ischaemic
Stroke 319597 319597 0 0
Haemorrhagic
Renal and Urogenital 320055 320055 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 320056 320056 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
The two TENS intervention protocols that will be assessed for safety and feasibility are:

Posterior Tibial Nerve TENS – With the appropriate level of assistance and supervision from carers, the participant will assume sitting or lying position with the legs extended. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrodes are attached on the medial malleolus and the negative electrodes are attached 10 cm (1 palm-width) above. The TENS machine with a locked pre-set of 10 Hz frequency and 200µs pulse width is turned on and the participant will increase the intensity to a maximum comfortable level below the threshold that causes motor contraction of the toes. The participant ensures that there is no pain or discomfort associated with the therapy. The therapy is delivered for 30 minutes and then the TENS machine is turned off.

Parasacral TENS – With the appropriate level of assistance and supervision from carers, the participant will lie down with a towel across the hips. Using the towel to maintain privacy, the pants and undergarments are lowered and the participant assumes a side-lying position with the knees bent. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrodes are placed on opposite sides of the second sacral spine and the negative electrodes on the inside of the middle and lower third of the junction between the posterior superior iliac spine and the ischial node. The participant then lies down on supine position and the TENS machine with a locked pre-set of 20 Hz frequency and 150µs pulse width is turned on. The participant will increase the intensity to a maximum comfortable level. The participant ensures that there is no pain or discomfort associated with the therapy. The therapy is delivered for 30 minutes and then the TENS machine is turned off.

Participants will be taught the TENS protocol on one day and then given a chance to perform the protocol while being observed by the investigator on the following day. During the observed practice session, the investigator will use an observation checklist to record if the participant required further support and what assistance was needed to perform the TENS protocol.

The participant flow through the study is expected to be completed in 4 days. An example of participant flow is as follows:
Day 1 - Learn posterior tibial TENS
Day 2 - Perform posterior tibial TENS then learn parasacral TENS
Day 3 - Perform parasacral TENS then learn sham (shoulder) TENS
Day 4 - Perform sham TENS

Randomisation will be done to determine the order of TENS protocols that participants are to try. There is no wash-out period involved in this safety and feasibility study.
Intervention code [1] 320508 0
Rehabilitation
Intervention code [2] 320509 0
Treatment: Devices
Comparator / control treatment
A sham TENS protocol will be assessed in this safety and feasibility study:

Shoulder TENS (sham) – With the appropriate level of assistance and supervision from carers, the participant will assume sitting or lying position. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrode is attached on the right shoulder and the negative electrode is attached on the left shoulder. The TENS machine with a locked pre-set of the lowest settings possible for the machine (2 Hz frequency and 50µs pulse width) is turned on and set at the maximum comfortable level below the sensory threshold. The participant ensures that there is no pain or discomfort associated with the therapy. The therapy is delivered for 30 minutes and then the TENS machine is turned off.
Control group
Active

Outcomes
Primary outcome [1] 327455 0
TENS protocol observation checklist:
During the observed practice session that follows each training, the investigator will complete a questionnaire to record the following:
(1) The length of time required by the participant to complete the one-on-one training session with the investigator;
(2) The ability of the participant to perform the steps of the TENS protocol without further input from the investigator;
(3) The assistance or supervision required by the participant to perform the TENS protocol;
(4) Comments made by the participant.
Timepoint [1] 327455 0
Days 2, 3, and 4 post-commencement of intervention.
Primary outcome [2] 327926 0
TENS protocol acceptability questionnaire:
During the observed practice session that follows each training, the investigator will complete a questionnaire to record the following:
(1) The perceived level of difficulty of the participant in performing the TENS protocol;
(2) The perceived likelihood of the participant to perform the TENS protocol after discharge;
(3) The likelihood of the participant to recommend the TENS protocol to people who develop incontinence after stroke (as an indicator of acceptability of the protocol); and
(4) Comments made by the participant.

The tool has been developed based on the Visual Analogue Scale (VAS) of the EuroQoL-5D that has been validated among stroke survivors and takes 5 minutes to administer.
Timepoint [2] 327926 0
Days 2, 3, and 4 post-commencement of intervention.
Secondary outcome [1] 395166 0
Completion rate of a 3-day urinary and faecal incontinence diary.
Timepoint [1] 395166 0
Days 1, 2, and 3 post commencement of intervention.
Secondary outcome [2] 397033 0
Completion rate of the 24-hour pad weight test.
Timepoint [2] 397033 0
Day 1 post commencement of intervention.
Secondary outcome [3] 397034 0
Completion rate of the EQ-5D.
Timepoint [3] 397034 0
Day 4 post commencement of intervention
Secondary outcome [4] 397035 0
Screening rate: assessed by recording the number of potentially eligible stroke survivors screened during their admission (from study screening logs), and the total number of stroke patients admitted per month by accessing medical records.
Timepoint [4] 397035 0
Throughout the study period (up to 1 year).
Secondary outcome [5] 397944 0
Recruitment rate: assessed by recording the number of participants who provided consent to participate and potentially eligible stroke survivors screened during their admission (from study screening logs).
Timepoint [5] 397944 0
Throughout the study period (up to 1 year).

Eligibility
Key inclusion criteria
(1) aged 18 years and older,
(2) diagnosis of acute stroke < 7 days from recruitment,
(3) identified as having new urinary or faecal incontinence by the interdisciplinary team
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) implanted electrical devices such as pacemakers or defibrillators,
(2) episode of seizures within 24 hours prior to recruitment,
(3) allergy to latex or adhesives,
(4) pre-existing incontinence that persisted to the month of stroke event,
(5) non-English speaker,
(6) no means to respond to questions effectively (patients with new communication difficulties are not necessarily excluded for as long as they have a way to respond to questions such as using a communication board),
(7) urinary or faecal diversion,
(8) pregnant,
(9) neuromuscular or dermal condition affecting the ankles, buttocks or shoulders,
(10) active malignant disease,
(11) no Medicare,
(12) no means to use a TENS machine (patients who may require assistance to use a TENS machine are not necessarily excluded for as long as they are able to ask for the assistance they require),
(13) concomitant participation in acute stroke trial.

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)
After eligibility assessment, concealed allocation will be done through central randomisation by a computer using Research Electronic Data Capture (REDCap) program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple random number sequence was generated via the online software Research Randomizer (https://www.randomizer.org/) and uploaded into REDCap to implement concealed allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Formal power calculations have not been undertaken for this feasibility study (note, this is consistent with usual practice). We plan to recruit n=18 participants to this feasibility study. Consecutive patients admitted to The Alfred Hospital ward 7-West with a diagnosis of stroke over a twelve month period will be screened for eligibility.

Non-parametric tests such as the Kruskal-Wallis test will be used to compare ordinal data from responses to questions on acceptability of the three TENS protocols. Correlation of continuous outcomes from incontinence severity scores and 24-hour pad weight tests will be reported as Pearson’s correlation. Eligibility, consent, retention and treatment adherence rates will be reported by TENS protocol type. Qualitative data from the list of comments will be analysed for themes using NVIVO and triangulated with observation and quantitative data to determine acceptability of the TENS protocols. Reasons for ineligibility, non-consent, non-randomisation and drop-out will be summarised.
Adverse events (AE) and serious adverse events (SAE) will be monitored by the research team and counts of all AEs will be compared between groups. Levels of missing data for outcomes will be reported using appropriate descriptive statistics and 95% confidence intervals constructed for the difference in outcomes between TENS protocol types.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2021
Actual
8/08/2022
Date of last participant enrolment
Anticipated
Actual
8/08/2022
Date of last data collection
Anticipated
12/08/2022
Actual
12/08/2022
Sample size
Target
18
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19367 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 33946 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308556 0
Charities/Societies/Foundations
Name [1] 308556 0
Continence Nurses Society Victoria and Tasmania Branch
Country [1] 308556 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 6, 99 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 309405 0
University
Name [1] 309405 0
La Trobe University
Address [1] 309405 0
Level 4, 99 Commercial Road, Melbourne VIC 3004
Country [1] 309405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308498 0
The Alfred HREC
Ethics committee address [1] 308498 0
Ethics committee country [1] 308498 0
Australia
Date submitted for ethics approval [1] 308498 0
20/01/2020
Approval date [1] 308498 0
02/03/2020
Ethics approval number [1] 308498 0
Alfred Project 57/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110914 0
Prof Geoffrey Cloud
Address 110914 0
Alfred Health Stroke Service
The Alfred Hospital
55 Comercial Road, Melbourne VIC 3004
Country 110914 0
Australia
Phone 110914 0
+61 390762552
Fax 110914 0
+61390762458
Email 110914 0
[email protected]
Contact person for public queries
Name 110915 0
Enrique Cruz
Address 110915 0
Alfred Health Continence Service
Caulfield Hospital
260 Kooyong Road, Caulfield VIC 3162
Country 110915 0
Australia
Phone 110915 0
+61 390766102
Fax 110915 0
+61390766435
Email 110915 0
[email protected]
Contact person for scientific queries
Name 110916 0
Enrique Cruz
Address 110916 0
Alfred Health Continence Service
Caulfield Hospital
260 Kooyong Road, Caulfield VIC 3162
Country 110916 0
Australia
Phone 110916 0
+61 390766102
Fax 110916 0
+61390766435
Email 110916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11623Ethical approval    381964-(Uploaded-19-06-2021-00-50-42)-Study-related document.pdf
12133OtherEthics approval of proposed amendments   381964-(Uploaded-19-06-2021-00-51-55)-Study-related document.pdf



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.