Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000041257
Ethics application status
Approved
Date submitted
4/12/2017
Date registered
15/01/2018
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results information initially provided
21/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pelvic floor muscle training in radical prostatectomy
Scientific title
Does a pre-operative functional pelvic floor exercise program provide improved post-operative urinary incontinence outcomes when compared with standard strength training in men undergoing radical prostatectomy? A pilot study.
Secondary ID [1] 293523 0
None
Universal Trial Number (UTN)
U1111-1206-1651
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 305712 0
Urinary Incontinence 305713 0
Radical Prostatectomy 305714 0
Condition category
Condition code
Cancer 304929 304929 0 0
Prostate
Renal and Urogenital 304930 304930 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional training group

Assessment of pelvic floor muscle/continence mechanism function and exercise prescription provided by pelvic floor physiotherapist with experience in men's health
The intervention may occur anywhere between 1-6 weeks prior to undergoing surgery, depending on timing of referral to physiotherapy and priority for surgery. Dates between intervention and surgery will be documented to determine duration of the intervention.
Participation in 2 x daily functional exercises that includes:
- x 10 sit to stand
- x 10 lunge left and right
- x 10 step ups left and right
- x 10 forward raise/side raise/overhead press with 2kg dumbbell each hand
- ** All exercises performed with pelvic floor muscle pre-contraction
Performed face to face in a community based setting within a hospital outpatients clinic
Each set of the program takes approximately 5-10 minutes in duration
Participants are recruited as early as possible after they have received a planned surgery date. This time frame may vary from 6 weeks-1 week. The time between pre-op exercise prescription and surgery date is recorded.
Adherence recorded via exercise diary
Intervention code [1] 299757 0
Prevention
Comparator / control treatment
Standard care group

Assessment of pelvic floor muscle/continence mechanism function and exercise prescription provided by pelvic floor physiotherapist with experience in men's health
The intervention may occur anywhere between 1-6 weeks prior to undergoing surgery, depending on timing of referral to physiotherapy and priority for surgery. Dates between intervention and surgery will be documented to determine duration of the intervention.
Participation in 3 x daily exercises that includes:
- Static holds
- Rapid contractions
- ** All exercises prescribed as per inidividual ability as per current standard care
Performed face to face in a community based setting within a hospital outpatients clinic
Each set of the program takes approximately 2-3 minutes
Participants are recruited as early as possible after they have received a planned surgery date. This time frame may vary from 6 weeks-1 week. The time between pre-op exercise prescription and surgery date is recorded.
Adherence recorded via exercise diary
Control group
Active

Outcomes
Primary outcome [1] 304127 0
Feasibility:
- Aim to recruit 30 participants in 12-18 months
Timepoint [1] 304127 0
18 months
Primary outcome [2] 304202 0
Feasibility:
Adherence to methodology with regards to:
- Number of participants who completed the study by completing and returning the ICIQ-UISF self reported questionnaire and pad weight records
Timepoint [2] 304202 0
24 months
Secondary outcome [1] 341040 0
3 day pad weight records to record volume of urinary leakage (this measure includes number of pads per day)
Timepoint [1] 341040 0
4, 12 and 24 weeks after the date of surgery
Secondary outcome [2] 341232 0
ICIQ-UISF total score and recorded bother score /10 at each timepoint
Timepoint [2] 341232 0
4, 12 and 24 weeks after the date of surgery
Secondary outcome [3] 341233 0
Time to continence recorded as the number of days between the date of surgery and no longer requiring the use of pads
Timepoint [3] 341233 0
Recorded between 0 and 182 days. Documented as not continent if not dry by 6 month review.
Secondary outcome [4] 341234 0
Number of Physiotherapy sessions attended within 6 months post surgery
Timepoint [4] 341234 0
Recorded between 0 and 182 days to be captured within 6 months post surgery
Secondary outcome [5] 341235 0
Time between initial pre-op assessment and surgery date. Recorded in days.
Timepoint [5] 341235 0
4 weeks post-operatively

Eligibility
Key inclusion criteria
1. Male patients admitted to the Western Continence service (WCS)
2. Men who have a planned surgery date for Radical Prostatectomy (RP)
3. Continent pre-operatively (no episodes of Urinary Incontinence (UI) in the 12 months prior to surgery)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female patients
2. Patients who have experienced UI in the 12 months prior to their surgery
3. Patients who are unable to complete the validated English questionnaire (i.e. non English speaking background, reduced cognition)
4. Pre-existing condition that limit functional capacity to participate in intervention group (e.g. neurological conditions that inhibit weight bearing positions, postures and balance).

Study design
Purpose of the study
Prevention
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)
Computer generated simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcomes we will calculate the appropriate frequency and corresponding proportions. For summary data and to assess secondary objectives, normally distributed data will be summarized as a mean and standard deviation; non-normally distributed data will be summarized as median with range; and categorical data will be summarized using frequency and corresponding proportions of each value. We will compare the outcomes from the two randomized groups using independent test of proportions or means, as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/12/2016
Date of last participant enrolment
Anticipated
7/06/2018
Actual
1/08/2018
Date of last data collection
Anticipated
7/12/2018
Actual
4/02/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9482 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 9483 0
Sunbury Day Hospital - Sunbury
Recruitment hospital [3] 9484 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 18220 0
3021 - St Albans
Recruitment postcode(s) [2] 18221 0
3429 - Sunbury
Recruitment postcode(s) [3] 18222 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 298135 0
Hospital
Name [1] 298135 0
Western Health
Country [1] 298135 0
Australia
Primary sponsor type
Individual
Name
Alesha Sayner
Address
Western Health
Sunshine Hospital
176 Furlong Road
St Albans
VIC 3021
Country
Australia
Secondary sponsor category [1] 297219 0
Hospital
Name [1] 297219 0
Western Health
Address [1] 297219 0
Western Health
Sunshine Hospital
176 Furlong Road VIC 3021
St Albans
VIC 3021
Country [1] 297219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299155 0
Western Health
Ethics committee address [1] 299155 0
176 Furlong Road
St Albans
VIC 3021
Ethics committee country [1] 299155 0
Australia
Date submitted for ethics approval [1] 299155 0
09/09/2016
Approval date [1] 299155 0
07/11/2016
Ethics approval number [1] 299155 0
HREC/16/WH/143

Summary
Brief summary
This pilot study will assess the feasibility and effect of pelvic floor muscle training (PFMT) on post-operative UI in men undergoing RP at Western Health.
WHO IS IT FOR?
Men with a planned surgery date for radical prostatectomy who have been admitted to the Western Continence Service (WCS) at Western Health. Men who are English speaking background and have not experienced any bladder leakage in the 12 months prior to their operation can participate. 30 men will be recruited to this study.
STUDY DETAILS
Men will attend to participate in the study prior to having their surgery. This randomized controlled trial (RCT) allocates men to one of two groups: The functional training group where they are asked to do a series of functional exercises such as steps ups and lunges with a pelvic floor muscle pre-contraction; or the standard care group where they perform static pelvic floor contractions as part of their program. Men will complete questionnaires and pad weights at 4, 12 and 26 weeks after their surgery to help collect data.
This study will assess the feasibility of this study and the potential for development of a larger scale study. It will also assess the effect that the above exercises have on post-operative UI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79482 0
Ms Alesha Sayner
Address 79482 0
Western Health
Sunshine Hospital
176 Furlong Road
St Albans
VIC 3021
Country 79482 0
Australia
Phone 79482 0
+61 3 8345 1355
Fax 79482 0
Email 79482 0
[email protected]
Contact person for public queries
Name 79483 0
Ms Alesha Sayner
Address 79483 0
Western Health
Sunshine Hospital
176 Furlong Road
St Albans
VIC 3021
Country 79483 0
Australia
Phone 79483 0
+61 3 8345 1355
Fax 79483 0
Email 79483 0
[email protected]
Contact person for scientific queries
Name 79484 0
Ms Alesha Sayner
Address 79484 0
Western Health
Sunshine Hospital
176 Furlong Road
St Albans
VIC 3021
Country 79484 0
Australia
Phone 79484 0
+61 3 8345 1355
Fax 79484 0
Email 79484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Cohort data regarding outcomes on study feasibility
Published results
When will data be available (start and end dates)?
From 01/06/2019
No end date determined
Available to whom?
Case by case basis at the discretion of the research team
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access available on request and distributed at the discretion of the principal investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Successful recruitment of 30 participants within 1... [More Details]

Documents added automatically
No additional documents have been identified.