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Trial registered on ANZCTR


Registration number
ACTRN12617001400358
Ethics application status
Approved
Date submitted
22/09/2017
Date registered
4/10/2017
Date last updated
17/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pelvic Floor Muscle Exercise Training in Prostatectomy Patients
Scientific title
Pelvic Floor Muscle Exercise Training in Prostatectomy Patients on urinary, sexual function and quality of life.
Secondary ID [1] 292952 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 304850 0
Urinary incontinence 304851 0
Erectile Dysfunction 304852 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304155 304155 0 0
Physiotherapy
Cancer 304211 304211 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to conduct a randomised controlled trial (RCT) of the impact of high intensity pelvic floor muscle exercise training (PFMET), versus usual care and sham PFMET, in prostatectomy patients. Participants will receive 3 sets of PFMET (usual care) or 6 sets of PFMET ( 6 sets fast and slow combination in functional positions), over 3 months.
1. The intervention for each group commences 4-6 weeks prior to prostatectomy and continues for 3 months post- prostatectomy
2. The Pelvic floor exercises consist of a number of sets completed/day with 6 sets to be completed each day with each set consisting of 10 x1 sec 'quick fibre' fast pelvic floor muscle contractions and 10 'slow fibre' holding contractions for 10 sec each, with a 10 sec rest and all sets to be performed in standing. A diary to record sets completed per day has been provided to each participant. The intervention will be taught one on one by a physiotherapist skilled in pelvic floor rehabilitation and a fortnightly review will ensure adherence to program, correct technique and ongoing assessment. The period of time for a crossover to take place is at 12 weeks post op for those in the usual care group who have not attained full continence..
Intervention code [1] 299191 0
Rehabilitation
Intervention code [2] 299192 0
Treatment: Other
Comparator / control treatment
Control Participants will receive 3 sets/day of PFMET (usual care) with only slow holds of 10sec endurance. in a supine position with each set consisting of 10 contractions/set. A physiotherapist will teach this pre-operatively one on one and a diary for participants to complete exercise targets has been provided.
Control group
Active

Outcomes
Primary outcome [1] 303464 0
Erectile Dysfunction - assessed by the standard questionaire forms including the International
Index of Erectile Function (IIEF) and the Expanded Prostate Index Composite- Clinical Practice (EPIC-CP) which assesses quality of life in prostate cancer patients, with a focus on urinary, bowel,sexual and psychological factors. The sexual domain scores can be used to assess erectile function.
Timepoint [1] 303464 0
The IIEF will be assessed pre-operatively and at 2 weeks, 6 weeks, 3 months and 6 months post prostatectomy.
Primary outcome [2] 303465 0
For urinary continence, the Internal Prostate Symptom Scoresheet will be used. (IPSS) as a standard measure of continence assessment.

Timepoint [2] 303465 0
The IPSS will be assessed pre-operatively and at 2 weeks, 6 weeks, 3 months and 6months post prostatectomy. will be assessed pre-operatively and at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post prostatectomy.
Primary outcome [3] 303466 0
Real time ultrasound pelvic floor test results will be taken to assess the pelvic floor muscle function and the relationship to urinary continence. Tests will assess the time taken to perform 10 quick pelvic floor contractions to assess fast twitch fibre function and a subsequent test will assess endurance, and the slow twitch fibre function to hold whilst timed for up to 60 seconds.
Timepoint [3] 303466 0
Real time ultrasound tests of pelvic floor muscle functio will be assessed pre-operatively and at 2 weeks, 6 weeks, 3 months 6 months and 12 months post prostatectomy.
Secondary outcome [1] 339006 0
Health related Quality of Life will be assessed by using the Expanded Prostate Index Composite- Clinical Practice (EPIC-CP) questionaire which assesses quality of life in prostate cancer patients, with a focus on urinary, bowel,sexual and psychological factors.
Timepoint [1] 339006 0
The EPIC-PC will be assessed at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post operatively
Secondary outcome [2] 339222 0
Nb: extra Primary outcome
24 hour pad weight will be used to assess urinary incontinence as a measure of mls lost over 24 hours, minus the number of dry pad weights used.
Timepoint [2] 339222 0
24 hour pad weight will be assessed at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post operaratively

Eligibility
Key inclusion criteria
Stage 1 & 2 PCa patients (n=50) over 18 years being treated by radical prostatectomy will be recruited prior to surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include; acute illness, current smokers (<1 year post quitting), patients with types 1 or 2 diabetes and those with alcohol consumption > 21 units/week. Participants with established but controlled risk factors for CVD will not be excluded from participation, nor will those receiving stable medications.

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)
Participants will receive an envelope on initial consultation which selection to 'control' or 'intervention group' will be nominated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
As some participants are expected to have ongoing urinary incontinence following three months of intervention, those in the usual care group will be offered the more intensive 'high intensity' regime of pelvic floor exercises for a period of three months
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
SSPS

Recruitment
Recruitment status
Completed
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)
WA

Funding & Sponsors
Funding source category [1] 297579 0
Self funded/Unfunded
Name [1] 297579 0
Joanne Milios
Address [1] 297579 0
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia
Country [1] 297579 0
Australia
Primary sponsor type
Individual
Name
Joanne Milios
Address
University of Western Australia
Entrance 4 Parkway
Crawley 6009
Western Australia

Country
Australia
Secondary sponsor category [1] 296592 0
None
Name [1] 296592 0
Address [1] 296592 0
Country [1] 296592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298671 0
Research Ethics and Biosafety Office Research Services. The University of Western Australia
Ethics committee address [1] 298671 0
The University of Western Australia
Research Ethics and Biosafety Office Research Services
Hackett Drive,
Crawley 6009
Western Australia
Ethics committee country [1] 298671 0
Australia
Date submitted for ethics approval [1] 298671 0
22/08/2013
Approval date [1] 298671 0
22/10/2013
Ethics approval number [1] 298671 0
RA/4/1/6372

Summary
Brief summary
The aim of this study is to evaluate the effect of two different pelvic floor muscle exercise training (PFMET) methods on urinary function, erectile dysfunction and quality of life in prostatectomy patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and have prostate cancer about to be treated by radical prostatectomy.

Study details
Participants will be allocated by chance to one of two exercise training programs which will complement usual components of continence management completed over a three months period. One group will receive the high intensity pelvic floor muscle exercise training (PFMET) and the other will receive sham PFMET. Other usual care components of management which both groups will receive include general continence, avoidance of caffeine and alcohol, and lifestyle modification advice. Measurement of urinary incontinence, erectile dysfunction and Quality of Life will be taken at completion of the intervention program.
This study may be beneficial to medical health care teams providing pre and post rehabilitation strategies for men undergoing surgery for prostate cancer. Both urinary incontinence and erectile dysfunction are expected side affects for men from treatment and methods to improve these have limited evidence in research currently.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77846 0
Mrs Joanne Milios
Address 77846 0
The University of Western Australia
Entrance 4 Parkway Rd,
Crawley 6009

also
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia
Country 77846 0
Australia
Phone 77846 0
+61 0408 022 950
Fax 77846 0
Email 77846 0
info.prost.inc@gmail.com
Contact person for public queries
Name 77847 0
Mrs Joanne Milios
Address 77847 0
The University of Western Australia
Entrance 4 Parkway Rd,
Crawley 6009

also
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia
Country 77847 0
Australia
Phone 77847 0
+61 0408 022 950
Fax 77847 0
Email 77847 0
info.prost.inc@gmail.com
Contact person for scientific queries
Name 77848 0
Prof Daniel Green
Address 77848 0
The University of Western Australia
Department of Human Services (School of Sport Science, Exercise & Health)
Entrance 4, Parkway Rd,
Crawley 6009
Western Australia
Country 77848 0
Australia
Phone 77848 0
+61 0400 1968 01
Fax 77848 0
Email 77848 0
danny.green@uwa.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary