Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000953932
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
24/09/2020
Date last updated
3/05/2021
Date data sharing statement initially provided
24/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of a text based reminder service to perform pelvic floor muscle exercises on the incidence of post prostatectomy stress urinary incontinence
Scientific title
The impact of a text based reminder service to perform pelvic floor muscle exercises on the incidence of post prostatectomy stress urinary incontinence in prostate cancer patients.
Secondary ID [1] 301675 0
None
Universal Trial Number (UTN)
U1111-1254-5807
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 318117 0
prostate cancer 318422 0
Condition category
Condition code
Renal and Urogenital 316139 316139 0 0
Other renal and urogenital disorders
Cancer 316429 316429 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A daily text will be sent to the participants mobile phone reminding them to do their pelvic floor exercises to prevent the development and persistence of stress urinary incontinence after removal of the prostate for prostate cancer. The urologist will refer the participant to a specialist pelvic floor therapist who will prescribe a pelvic floor exercise program. The exercise program is a daily regime to be performed by the participant at home at least three times a day of varying intensity as tolerated. The exercises can be performed during voiding where the participant may be asked to "shorten the penis"; "interrupt their flow of urine"; "Pretend they are gently crushing a straw". They should avoid clenching their bottom and focus on keeping their tummy soft with gently breathing. The reminder text will be sent from an accredited independent provider at the University of Sydney. The text message system has been validated and used in other studies. The text messages will start being delivered 2 weeks prior to surgery and will resume 2 weeks after surgery up to 3 months. A generic message will be sent out to all participants to remind them to do their pelvic floor muscle exercises which will also include alternating but random specific exercise prompts (such as those previously mentioned). The independent provider has a monitoring facility by way of message delivery software which is able to determine whether messages are delivered or not. Adherence will be assessed by means of a participant diary and follow up questionnaire.
Intervention code [1] 317983 0
Treatment: Other
Comparator / control treatment
A text message will be sent to the participants mobile phone reminding them to do their pelvic floor exercises to prevent the development and persistence of stress urinary incontinence after removal of the prostate for prostate cancer. The text will be sent from an accredited independent provider at the University of Sydney. The text message system has been validated and used in other studies. The difference compared to the intervention is that a single text messages will be delivered only once at the beginning of the 2 weeks prior to surgery and then only one text message every 4 weeks up to 3 months after surgery.
Control group
Active

Outcomes
Primary outcome [1] 324328 0
Incidence of post-prostatectomy incontinence will be measured by number of pads used, this information will be recorded by participants in the study diary,
Timepoint [1] 324328 0
Time it takes to reach zero pad usage measured at 2 weeks, 6 weeks and 3 months.
Secondary outcome [1] 384335 0
Daily adherence to pelvic floor muscle exercises will be assess using a participant diary and also a study-specific questionnaire (Exercise adherence rating scale)
Timepoint [1] 384335 0
Six weeks and three months post-surgery
Secondary outcome [2] 385031 0
Motivation to perform pelvic floor exercise (Assessed using the incontinence treatment motivation questionnaire) and participant diary
Timepoint [2] 385031 0
Assessed at 6 weeks and 3 months post-surgery
Secondary outcome [3] 385032 0
Acceptance and tolerability of the text message service by participants as measure by a tolerability questionnaire (This questionnaire was designed specifically for the study)
Timepoint [3] 385032 0
3months post-surgery
Secondary outcome [4] 385033 0
To assess whether pre-operative perceptions effect post-operative outcomes with a readiness for surgery questionnaire (This questionnaire was specifically designed for the trial)
Timepoint [4] 385033 0
Assessed 2 weeks pre-operatively and at 3 months post-operatively

Eligibility
Key inclusion criteria
Men over the age of 30 with confirmed prostate cancer (any stage that’s eligible for surgery), informed consent and an active mobile telephone.
Minimum age
30 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have pre-existing incontinence or an IPSS (International prostate symptom score) above 19 will be excluded. Participants without an active mobile phone,

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We focused our sample size calculation on difference in objective measures of outcomes between intervention and control groups. The power calculation (a=0.05, ß1=80%) determined a sample size of 126 (equally divided between control and intervention). This was determined by proposing that time to zero pad usage in the control group will be 8 (+/-4) weeks and 6 weeks for the intervention group. We will follow the intention to treat principle and analyse patients in the treatment group to which they are allocated. Characteristics will be compared using the independent T-Tests or Chi square tests as appropriate. We will compare the number of pads needed at 2 weeks, 6 weeks and 3 months post-surgery between each arm of the study to determine the differing rates of incontinence. We will investigate the possible effects of baseline effect modifiers or confounders using logistic regression analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/09/2020
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
1/11/2021
Actual
Sample size
Target
126
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17018 0
Westmead Hospital - Westmead
Recruitment hospital [2] 17019 0
Westmead Private Hospital - Westmead
Recruitment postcode(s) [1] 30686 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306112 0
Hospital
Name [1] 306112 0
Westmead Hospital - Department of Urology
Country [1] 306112 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital - Department of Urology
Address
Westmead Hospital
Hawkesbury Road
Westmead
NSW
2145
Country
Australia
Secondary sponsor category [1] 306582 0
None
Name [1] 306582 0
Address [1] 306582 0
Country [1] 306582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306329 0
Western Sydney Local Health District Research Ethics
Ethics committee address [1] 306329 0
Cnr Darcy and Hawkesbury Roads
Westmead
NSW
2145
Ethics committee country [1] 306329 0
Australia
Date submitted for ethics approval [1] 306329 0
08/05/2020
Approval date [1] 306329 0
21/07/2020
Ethics approval number [1] 306329 0
2020/PID00854

Summary
Brief summary
This study is assessing whether a cellphone text based reminder service will improve the likelihood of participants carrying out their pelvic floor muscle exercises at home to lessen the chance of leaking urine after surgery for removal of the prostate due to prostate cancer.

Who is it for?
You may be eligible for this study if you are a male aged 30 years or older, who has been diagnosed with prostate cancer that is eligible for surgery to remove your prostate, and you have access to a mobile phone.

Study details
Participants in this study will be randomly assigned to one of two groups. The first group will receive daily text message reminders to complete their prescribed pelvic floor exercises. The text messages will be sent for up to 2 weeks prior to their prostate removal surgery, and will then be sent daily starting 2 weeks after their surgery for up to 3 months after surgery. The second group will receive the same text message reminder only once 2 weeks before their surgery, then once 2 weeks after their surgery and then once every 4 weeks for up to 3 months after surgery. All participants will be asked to complete a study diary to record whether they have completed their pelvic floor exercises each day, as well as to note how many incontinence pads they used each day after their surgery. Participants will also be asked to complete a study questionnaire at set timepoints, which will ask you about any incontinence you have experienced after surgery, and for your thoughts on the text message reminder service.

It is hoped this research will determine whether text message reminders about completing pelvic floor exercises regularly will lead to improved health outcomes for prostate cancer patients by helping to reduce the incidence of post-prostate removal surgery incontinence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103518 0
Prof Manish Patel
Address 103518 0
Department of Urology
Westmead Hospital
Hawkesbury Road
Westmead
NSW
2145
Country 103518 0
Australia
Phone 103518 0
+61 296878252
Fax 103518 0
Email 103518 0
Contact person for public queries
Name 103519 0
Ms Julie Ashbourne
Address 103519 0
Department of Urology
Westmead Hospital
Hawkesbury Road
Westmead
NSW
2145
Country 103519 0
Australia
Phone 103519 0
+61 0288906693
Fax 103519 0
Email 103519 0
[email protected]
Contact person for scientific queries
Name 103520 0
Prof Manish Patel
Address 103520 0
Department of Urology
Westmead Hospital
Hawkesbury Road
Westmead
NSW
2145
Country 103520 0
Australia
Phone 103520 0
+61 296878252
Fax 103520 0
Email 103520 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained


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.