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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer

Urinary incontinence

Erectile Dysfunction

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Cancer

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]

Rehabilitation

Intervention code [2]

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]

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]

The IIEF will be assessed pre-operatively and at 2 weeks, 6 weeks, 3 months and 6 months post prostatectomy.

Primary outcome [2]

For urinary continence, the Internal Prostate Symptom Scoresheet will be used. (IPSS) as a standard measure of continence assessment.

Timepoint [2]

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]

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]

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]

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]

The EPIC-PC will be assessed at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post operatively

Secondary outcome [2]

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]

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

Sex

Males

Can healthy volunteers participate?

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

1/06/2016

Date of last participant enrolment

Anticipated

31/12/2017

Actual

31/12/2017

Date of last data collection

Anticipated

31/12/2018

Actual

30/06/2018

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Joanne Milios

Address [1]

Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics and Biosafety Office Research Services. The University of Western Australia

Ethics committee address [1]

The University of Western Australia
Research Ethics and Biosafety Office Research Services 
Hackett Drive, 
Crawley 6009
Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/08/2013

Approval date [1]

22/10/2013

Ethics approval number [1]

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

Mrs Joanne Milios

Address

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

Australia

Phone

+61 0408 022 950

Fax

info.prost.inc@gmail.com

Contact person for public queries

Name

Joanne Milios

Address

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

Australia

Phone

+61 0408 022 950

Fax

info.prost.inc@gmail.com

Contact person for scientific queries

Name

Daniel Green

Address

The University of Western Australia
Department of Human Services (School of Sport Science, Exercise & Health)
Entrance 4, Parkway Rd,
Crawley 6009
Western Australia

Country

Australia

Phone

+61 0400 1968 01

Fax

danny.green@uwa.edu.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Pelvic floor muscle training in radical prostatectomy: A randomized controlled trial of the impacts on pelvic floor muscle function and urinary incontinence.	2019	https://dx.doi.org/10.1186/s12894-019-0546-5
Embase	Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation.	2020	https://dx.doi.org/10.1016/j.esxm.2020.03.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically