Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000794808
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
24/06/2021
Date last updated
24/06/2021
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating urinary incontinence with pelvic floor muscle training in women with breast cancer: a telehealth study.
Scientific title
The feasibility of pelvic floor muscle training to treat urinary incontinence in women with breast cancer: a telehealth intervention trial.
Secondary ID [1] 304063 0
Nil
Universal Trial Number (UTN)
Trial acronym
PFMTinBC

pelvic floor muscle training in breast cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 321706 0
Breast cancer 322174 0
Condition category
Condition code
Renal and Urogenital 319447 319447 0 0
Other renal and urogenital disorders
Cancer 319859 319859 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
What: The intervention is a 12-week pelvic floor muscle training program using a biofeedback device called the femfit®. The femfit® is a self-monitoring device which is inserted intravaginally and measures the intravaginal squeeze pressure during pelvic floor muscle contractions. Participants who are eligible and consent to the study will be provided with a femfit® via post. Participants must have access to a device with internet access and ZoomTM to engage in this program for video conferencing purposes and to download the femfit® application on to their mobile phone. Each telehealth session will be approximately 30mins in duration. In the first telehealth session, participants will learn how to contract their pelvic floor muscles, how to complete their home exercise program and how to use the femfit® to monitor this. The pressure readings on the femfit® display will be used to indicate when the participant is able to correctly contract the pelvic floor muscles. The researcher will then teach the participant her starting level of the pelvic floor muscle training program. The purpose of pelvic floor muscle training is to strengthen the pelvic floor muscle and increase the urethral closure pressure to prevent urinary leakage. All seven follow-up sessions will be conducted via a web-based platform such as ZoomTM. Audio and video conferencing sessions used to deliver the remote instruction will not be recorded. No specific exercise equipment is required other than the femfit® device and phone app.
Who: The program will be conducted by the Principal Investigator, a registered physiotherapist.

How: Participants will receive eight supervised, individual pelvic floor muscle training sessions over a period of 12 weeks. Exercises will be prescribed according to each woman’s starting level of PFM contraction ability (length of hold, number of repetitions) and progressed up to the optimal target dosage for PFM strength training: eight to twelve repetitions of pelvic floor muscle contractions, held for eight-seconds, two - three sets per day in the prescribed position. Further progression of exercises may include increasing the load of the exercise by progressing from across-gravity (lying) to against-gravity (sit or stand) positions. The home exercise program will take 8-16mins to complete everyday. Strategies to engage participants with the uptake of the exercise program will include exploring their barriers and enablers to pelvic floor muscle training in the first session, monitoring adherence to the program using an exercise diary and scheduling follow-up sessions.

Where: The exercise program will be delivered online via ZoomTM.
Intervention code [1] 320382 0
Treatment: Other
Intervention code [2] 320745 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327313 0
Feasibility is the primary outcome of this study based on consent rate. The consent rate will be assessed through an audit of study enrolment and screening logs.
Timepoint [1] 327313 0
This outcome will be calculated at the end of the recruitment period using the number of participants who consent for the trial divided by the total number of participants who are eligible but did not consent to the trial.
Secondary outcome [1] 394578 0
Retention rate: number of participants who complete the whole 12-week trial divided by the number of participants who initially consented to the trial. This will be assessed through an audit of study enrolment and screening logs.
Timepoint [1] 394578 0
This outcome will be calculated after the intervention at the conclusion of the study.
Secondary outcome [2] 394579 0
Attendance rate: number of sessions attended out of eight. This will be assessed through an audit of session attendance logs.
Timepoint [2] 394579 0
This outcome will be calculated after the intervention at the conclusion of the study.
Secondary outcome [3] 394825 0
Adherence rate: number of days the participant completed the home exercise program divided by 91 days (3 months). This will be assessed through an exercise diary.
Timepoint [3] 394825 0
This outcome will be calculated after the intervention at the conclusion of the study.
Secondary outcome [4] 394826 0
Withdrawal rate: number of participants who withdrew from the trial after consenting divided by the number of participants who initially consented to the trial. This will be assessed through an audit of study enrolment and screening logs.
Timepoint [4] 394826 0
This outcome will be calculated after the intervention at the conclusion of the study.
Secondary outcome [5] 394827 0
Adverse and serious adverse events: the number of adverse or serious adverse events will be assessed as a composite outcome. This will be assessed through interviews in telehealth sessions throughout the 12 week intervention period.
Timepoint [5] 394827 0
This outcome will be measured after the intervention. The number of adverse events data will be assessed throughout the 12 week intervention period.
Secondary outcome [6] 394828 0
Acceptability: participant experience questions (about the exercise program and use of femfit®) designed specifically for this study.
Timepoint [6] 394828 0
This outcome will be measured after the intervention at the end of the 12 week intervention period.
Secondary outcome [7] 394829 0
Satisfaction: five-point Likert-type scale ranging from ‘1 = very dissatisfied’ to ‘5 = very satisfied’.
Timepoint [7] 394829 0
This outcome will be measured after the intervention at the end of the 12 week intervention period.
Secondary outcome [8] 394830 0
Pelvic floor muscle strength using intravaginal pressure (mmHg) using the femfit® device.
Timepoint [8] 394830 0
This outcome will be collected before and after the intervention at week 1 and week 12 of the intervention period.
Secondary outcome [9] 394831 0
Frequency of urinary incontinence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Timepoint [9] 394831 0
This outcome will be collected before and after the intervention at week 1 and week 12 of the intervention period.
Secondary outcome [10] 396378 0
Severity of urinary incontinence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Timepoint [10] 396378 0
This outcome will be collected before and after the intervention at week 1 and week 12 of the intervention period.
Secondary outcome [11] 396379 0
Impact of urinary incontinence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Timepoint [11] 396379 0
This outcome will be collected before and after the intervention at week 1 and week 12 of the intervention period.
Secondary outcome [12] 396380 0
Participant impression of change in urinary incontinence using the Patient’s Global Impression of Change (PGIC) scale.
Timepoint [12] 396380 0
This outcome will be collected after the intervention at the end of the 12 week intervention period.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Women who have been diagnosed with a histologically confirmed breast tumour (stages I-IV).
• Women who currently experience stress urinary incontinence (urinary leakage when they cough or sneeze).
• Women between 18-80 years of age.
• Women who have sufficient English language skills to understand instructions from the researcher.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Women who have neurological disorders or have severe physical/psychiatric impairments.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Participant demographics and summary scores from questionnaires will be reported descriptively using means and standard deviations for normally distributed continuous data, and frequencies and percentages for categorical variables. Feasibility data will be reported using descriptive statistics. Participant flow will be presented in a participant flow diagram, including the numbers of participants who expressed interest for the study, received intended treatment, and were assessed for each outcome measure. Attendance, adherence, and any withdrawals or adverse events will also be presented in this flow diagram as percentages.
Pre and post measures of scores of the intravaginal pressure from the femfit® and the ICIQ-UI SF will be compared using paired t-tests (if parametric) or Wilcoxon Signed Rank test (if non-parametric) depending on the distribution of data. The participants’ impression of change in urinary incontience will be presented as a mean and standard deviation. All analyses will be tested with a significance level of p<0.05 using SPSS 25.0 software (IBM Corp, Armonk, NY).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/06/2021
Actual
Date of last participant enrolment
Anticipated
10/12/2021
Actual
Date of last data collection
Anticipated
10/03/2022
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308445 0
University
Name [1] 308445 0
The University of Melbourne
Country [1] 308445 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
161 Barry St, Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 309652 0
None
Name [1] 309652 0
Address [1] 309652 0
Country [1] 309652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308400 0
Monash University
Ethics committee address [1] 308400 0
Moorooduc Hwy, Frankston VIC 3199
Ethics committee country [1] 308400 0
Australia
Date submitted for ethics approval [1] 308400 0
30/11/2020
Approval date [1] 308400 0
25/02/2021
Ethics approval number [1] 308400 0
27002

Summary
Brief summary
This study is aiming to determine the feasibility of delivering pelvic floor muscle training using telehealth to treat urinary incontinence in women with breast cancer in Australia.

Who is it for?
You may be eligible for this study if you are aged 18-80, you have been diagnosed with breast cancer (stages I-IV) and you are currently experiencing stress urinary incontinence (urinary leakage when you cough or sneeze).

Study details
All participants who choose to enrol in this study will receive a femfit® device that provides live data on the person's ability to correctly contract their pelvic floor muscles. All participants will be offered 8 instructional sessions with the research physiotherapist via videoconference (e.g. Zoom platform) over a 12 week period. Each session will be 30 mins in duration. Using the femfit® device, the research physiotherapist will then teach the pelvic floor muscle training program. As a home exercise program, the participant will complete the pelvic floor muscle training program using the femfit® app and record their progress on an exercise diary. Participants will be asked to complete an online questionnaire to assess the frequency, severity and impact of their urinary incontinence at the start and end of the 12 week intervention. They will also complete a questionnaire measuring their satisfaction of the program and perceived change in urinary incontinence at the end of the 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110586 0
Miss Udari Colombage
Address 110586 0
The University of Melbourne, 161 Barry St, Carlton VIC 3053
Country 110586 0
Australia
Phone 110586 0
+61 404867739
Fax 110586 0
Email 110586 0
ucolombage@student.unimelb.edu.au
Contact person for public queries
Name 110587 0
Miss Udari Colombage
Address 110587 0
The University of Melbourne, 161 Barry St, Carlton VIC 3053
Country 110587 0
Australia
Phone 110587 0
+61 404867739
Fax 110587 0
Email 110587 0
ucolombage@student.unimelb.edu.au
Contact person for scientific queries
Name 110588 0
Miss Udari Colombage
Address 110588 0
The University of Melbourne, 161 Barry St, Carlton VIC 3053
Country 110588 0
Australia
Phone 110588 0
+61 404867739
Fax 110588 0
Email 110588 0
ucolombage@student.unimelb.edu.au

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
11491Study protocol  ucolombage@student.unimelb.edu.au
11492Ethical approval  ucolombage@student.unimelb.edu.au
11493Statistical analysis plan  ucolombage@student.unimelb.edu.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of pelvic floor training to treat urinary incontinence in women with breast cancer: a telehealth intervention trial.2023https://dx.doi.org/10.1007/s12282-022-01405-6
N.B. These documents automatically identified may not have been verified by the study sponsor.