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Trial registered on ANZCTR


Registration number
ACTRN12618002058257
Ethics application status
Approved
Date submitted
26/11/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Study Assessing Urinary Continence following Robotic Radical Prostatectomy with or without an intraoperative 'RoboSling'.
Scientific title
Randomised Study Assessing Urinary Continence following Robotic Radical Prostatectomy with or without an Intraoperative Retropubic Vascularised Fascial Sling (RoboSling)
Secondary ID [1] 296717 0
nil
Universal Trial Number (UTN)
Trial acronym
RoboSling
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 310569 0
Urinary Incontinence 310570 0
Condition category
Condition code
Cancer 309282 309282 0 0
Prostate
Renal and Urogenital 309283 309283 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will first complete a baseline questionnaire when they consent to the trial, and undergo pre-operative urinal functional testing by a urologist (including a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment). They will then proceed to a robotic-assisted radical prostatectomy surgery, incorporating the construction of a retropubic vascularised fascial sling (RoboSling, the 'intervention'), completed by their treating urological surgeon. The RoboSling is created by dissecting a piece of peritoneum (abdominal lining tissue) off f the rear surface of the bladder, which is then brought underneath the bladder to the front, and top corners of the flap stitched upwards under tension to the pubic bone).

After surgery, intervention participants will complete a series of 6 post-operative questionnaires at set follow-up timepoints up to one year post-operative when visiting their surgeon for post-operative review/management appointments, and again undergo post-operative urinal functional testing at one-year with a urologist.

The control (comparator) group will undergo all these procedures except their surgery will NOT include the construction of a RoboSling.
Intervention code [1] 313024 0
Treatment: Surgery
Comparator / control treatment
Participants in the control group will complete a baseline questionnaire, undergo pre-operative urinal functional testing (including a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment), then proceed to a standard robotic-assisted radical prostatectomy, and afterwards complete a series of 6 post-operative questionnaires at set timepoints up to one year post-operative and undergo post-operative urinal functional testing at one-year.
Control group
Active

Outcomes
Primary outcome [1] 308257 0
To determine the impact of incorporating the RoboSling procedure with
robot-assisted radical prostatectomy (RARP) surgeryon early (3 months) and late (1 year) post-operative urinary continence, compared to RARP alone. This will be measures by the rate of patient reported continence defined as 0 urinary pad usage per day at 3 months and 1 year post-operatively.
Timepoint [1] 308257 0
3-months and 1-year post-operative
Secondary outcome [1] 354433 0
To identify urinary functional parameters which may differ between the intervention group and the control group.
Urinary function will be measured as a composite outcome: functional parameters assessed will include Qmax, detrusor leak point and pressure, bladder compliance, storage dysfunction (OAB) and voiding dysfunction (BOO, detrusor underactivity, stress or urgency incontinence), pelvic floor contraction and mobility. These will be measured by pre- and post-operative urinary functional tests completed by a urologist, which include a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment.
Timepoint [1] 354433 0
1-year post-operative
Secondary outcome [2] 354434 0
To identify differences in peri-operative complications between the intervention group and control group.
Known potential complications of the procedure include pain, urinary incontinence and bleeding, Other less likely complications may include infection, visceral injury, sepsis and death (all extremely unlikely). Incidence of complications will be recorded for each participant and checked through medical record review, and compared between the study groups.
Timepoint [2] 354434 0
Up to 2 weeks post-operative
Secondary outcome [3] 354435 0
To identify anatomic features which may result in poorer post-operative functional outcomes after RARP between the intervention group and the control group, as measured on radiological imaging scans (CT and/or MRI) and perineal/pelvic floor ultrasound, and through urodynamic tests by a urologist.
Timepoint [3] 354435 0
1-year post-operative
Secondary outcome [4] 354436 0
To assess post-operative sexual function outcomes between the intervention group and the control group, as assessed by patient-reported Sexual Health Inventory for Men (SHIM) questionnaire.
Timepoint [4] 354436 0
2-weeks, 6-weeks, 3-months, 6-months, 9-months and 1-year post-operative.
Secondary outcome [5] 354437 0
To prospectively assess patient reported Quality of Life by patient-reported SF-36 v2 questionnaire.
Timepoint [5] 354437 0
Pre-operative, and 2-weeks, 6-weeks, 3-months, 6-months, 9-months and 1-year post-operative.
Secondary outcome [6] 354438 0
To prospectively assess health economic outcomes of robot-assisted radical prostatectomy surgery by patient-reported work and care responsibilities and health care utilisation questionnaire (designed specifically for use in the Royal Prince Alfred Hospital Robotic Research Program).
Timepoint [6] 354438 0
6-weeks and 6-months post-operative.
Secondary outcome [7] 354439 0
To assess "decision regret" regarding surgical treatment between the intervention group and the control group by patient reported Decision Regret Scale (DRS) questionnaire.
Timepoint [7] 354439 0
6-weeks, 3-months and 1-year post-operative.

Eligibility
Key inclusion criteria
To be eligible to enter the study all patients must satisfy the following criteria:
1. Adult men aged 18 years and over
2. Undergoing prostatectomy for prostate cancer at RPA hospital in Sydney, Australia
3. Clinically suitable for robotic prostatectomy
4. Cognitively able to give written informed consent for participation
5. Elective procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they present the following exclusion criteria:
1. The patient lacks the ability to consent for themselves
2. Patient or tumour factors precluding robotic surgery

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)
Randomisation will be generated by computer generated code and participant allocation will be concealed until the day of surgery. The surgeon will be notified of the allocation by phone prior to surgery. Patients and members of the study team conducting data collection and analysis will not be notified of allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly determined by computer generated code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
1:1 ratio random assignment
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Clinically relevant baseline variables will be tabulated and compared between groups.
Categorical variables will be compared between groups using the chi-squared test
(frequencies and proportions). Continuous variables will be compared using t-test (means) or Wilcoxon 2-sample test (median). Unadjusted rates of continence will be compared between groups with the Fisher exact test. All data will be stored in a REDCap database and statistical analysis will be performed using SPSS version 22 (SPSS Inc, Chicago, IL, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12557 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 12558 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 24936 0
2050 - Camperdown
Recruitment postcode(s) [2] 24937 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 301298 0
Government body
Name [1] 301298 0
Sydney Local Health District
Address [1] 301298 0
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country [1] 301298 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300949 0
None
Name [1] 300949 0
Address [1] 300949 0
Country [1] 300949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302039 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) [EC00113]
Ethics committee address [1] 302039 0
Research Development Office
Suite 2A, 100 Carillon Ave
Newtown NSW 2042
Ethics committee country [1] 302039 0
Australia
Date submitted for ethics approval [1] 302039 0
11/09/2017
Approval date [1] 302039 0
11/10/2018
Ethics approval number [1] 302039 0
X17-0339 & HREC/17/RPAH/518

Summary
Brief summary
The purposes of this study is to assess the urinary function of men undergoing a prostatectomy with and without a 'RoboSling', which is a thin piece of the patient's abdominal lining tissue that is stitched to the pubic bone during surgery to support the bladder.

Who is it for?
You may be eligible for this study if you are aged at least 18 years and are undergoing a prostatectomy for prostate cancer with one of the participating surgeons involved in this study.

Study details
Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed prostatectomy procedure. One group will have a standard procedure, and the other group will have a standard procedure with the creating of a ‘RoboSling’ from their abdominal lining tissue during surgery. All participants will complete a number of questionnaires at 7 timepoints over the weeks and months just prior to and following their surgery.

It is intended that this study will help to improve urinary continence in men after prostatectomy surgery in the future.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 88930 0
Dr Scott Leslie
Address 88930 0
Missenden Medical Centre
Suite 7B, 54-60 Briggs St
Camperdown 2050 NSW
Country 88930 0
Australia
Phone 88930 0
+61295191331
Fax 88930 0
+61294755234
Email 88930 0
info@scottleslie.com.au
Contact person for public queries
Name 88931 0
Dr Scott Leslie
Address 88931 0
Missenden Medical Centre
Suite 7B, 54-60 Briggs St
Camperdown 2050 NSW
Country 88931 0
Australia
Phone 88931 0
+61295191331
Fax 88931 0
+61294755234
Email 88931 0
info@scottleslie.com.au
Contact person for scientific queries
Name 88932 0
Dr Scott Leslie
Address 88932 0
Missenden Medical Centre
Suite 7B, 54-60 Briggs St
Camperdown 2050 NSW
Country 88932 0
Australia
Phone 88932 0
+61295191331
Fax 88932 0
+61294755234
Email 88932 0
info@scottleslie.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound proposal, at the discretion of the Primary Investigator and Trial Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access via secure file, subject to approvals by Principal Investigator and Trial Sponsor with the requirement to sign a data access agreement.
What supporting documents are/will be available?
No other documents available
Summary results
No Results