Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000788370
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
30/05/2017
Date last updated
9/02/2023
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised pelvic floor Muscle Training for Urinary incontinence after Prostatectomy
Scientific title
Efficacy of a personalised pelvic floor Muscle Training program on Urinary incontinence after radical Prostatectomy: A randomised clinical trial with embedded physiological studies
Secondary ID [1] 291182 0
None
Universal Trial Number (UTN)
U1111-1196-7696
Trial acronym
MaTchUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-prostatectomy incontinence 302062 0
Urinary incontinence 302063 0
Prostate Cancer 302655 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301695 301695 0 0
Physiotherapy
Cancer 302170 302170 0 0
Prostate
Renal and Urogenital 302171 302171 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(i) Urethral muscle training - comprehensive individualized program focused on training the striated muscles that pressurize the urethra. Exercise relies on the principles of motor skill training with trans-perineal ultrasound imaging for assessment (during voluntary contraction, coughing and a 60-s maximal contraction) and biofeedback. Training is based on assessment outcomes and commences with skill acquisition (training of optimal muscle recruitment patterns to increase urethral pressure). A key focus is the striated urethral sphincter, but with tailoring to include the other muscles, based on the assessment. Treatment is progressed using principles of exercise physiology according to a decision tool developed with the Clinical Advisory Committee. Based on the assessed needs and deficits of the patient, progression includes; training of sustained holding to enhance adaptation of striated muscles to provide ongoing maintenance of continence, training of ballistic efforts for episodes of increased bladder pressure (lifting, coughing, etc), skill development for functional training into broad range of activities including training with increasing bladder volumes, and high performance training for demanding tasks including strength training. Daily home exercise to practice tasks taught in each session is encouraged and monitored.

Participants in Urethral training group will attend up to 10 sessions of face-to-face pelvic floor muscle training supervised by a physiotherapist. The number of sessions will be determined by the need for further training at the discretion of the treating physiotherapist or when the participant meets the criteria for continence defined as no urine loss for 5 days and no urine loss on the 24 hour pad test. Each session will last approximately 30 minutes. Participants will attend a session 1-2 weeks prior to surgery. Participants will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). Adherence to treatment (home-based exercises) will be recorded using a weekly diary which will be inspected by the physiotherapist at each face-to-face treatment session. Participants will be instructed to perform their home-based exercise program with frequency and intensity guided by their capacity. Home exercises will involve practice of the tasks provided by their physiotherapist at the previous visit based on individualized assessment. Adherence to exercise will be encouraged by the physiotherapist and formally recorded monthly with other outcome measures using an online questionnaire.
Intervention code [1] 297182 0
Rehabilitation
Intervention code [2] 297620 0
Treatment: Other
Comparator / control treatment
(ii) Conventional training program - training focused on muscles around the anus. This program is commonly offered in physiotherapy clinics and hospitals and will follows principles used in most previous clinical trials. Training commences with assessment of muscle activation which may include digital rectal examination or anal surface electromyography (EMG). Participants perform three maximal voluntary contractions held for up to 10 seconds in three positions (lying, sitting and standing) twice per day. Daily home exercise is encouraged and monitored. Training progresses by hold duration. Treatment is supervised by a physiotherapist using the same schedule as that described for the Urethral training program.

(iii) No training control group - Participants will be provided with an information sheet that includes description of pelvic floor muscle anatomy and brief instruction on how to perform pelvic floor muscle exercise (as is currently standard in many hospital settings). Participants will be requested to refrain from seeking additional treatment until the primary end point at 3 months. Any treatment sought by participants will be recorded. Participants in this group will not be guided to perform home exercises.
Control group
Active

Outcomes
Primary outcome [1] 301088 0
Continence defined by the 24-hour pad weight test. Continence will be defined as a loss of <2g of urine.
Timepoint [1] 301088 0
3 months post-operative.
Secondary outcome [1] 331699 0
Health-related quality of life - measured using the 12-Item Short Form Survey (SF-12)
Timepoint [1] 331699 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. The measure will be collected once more at 12 months.
Secondary outcome [2] 335222 0
Symptomatology and “bothersomeness” of incontinence - measured by the International Continence Society Male Short Form Questionnaire
Timepoint [2] 335222 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. After 3 months the measure will be collected monthly until 12 months.
Secondary outcome [3] 335238 0
Continence-related costs – measured using an electronic diary of continence-related costs
Timepoint [3] 335238 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. After 3 months the measure will be collected monthly until 12 months.
Secondary outcome [4] 335239 0
24-hour pad weight test
Timepoint [4] 335239 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. After 3 months the measure will be collected monthly until 12 months.
Secondary outcome [5] 335240 0
Measures of neuro-muscular control of urethral pressure assessed by the ultrasound measures of activation of pelvic floor muscles during (i) voluntary contraction of pelvic floor muscles; (ii) cough; and (iii) sustained 60-s maximal contraction of pelvic floor muscles
Timepoint [5] 335240 0
Baseline, the week of catheter removal after surgery, 6 weeks, 3 months and 12 months
Secondary outcome [6] 346334 0
International Physical Activity Questionnaire (IPAQ) to assess physical activity over the period the 24 hour pad weight test is conducted.
Timepoint [6] 346334 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. After 3 months the measure will be collected monthly until 12 months.
Secondary outcome [7] 346335 0
EQ-5D-5L questionnaire to calculate Quality-Adjusted Life-Years for cost-effectiveness analysis.
Timepoint [7] 346335 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. The measure will be collected once more at 12 months.
Secondary outcome [8] 346336 0
Sexual function will be recorded to understand how it relates to the primary outcome (continence). Sexual function will be determined by asking participants "Are you currently able to achieve a full erection?".
Timepoint [8] 346336 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. The measure will be collected once more at 12 months.
Secondary outcome [9] 346337 0
Bowel function will be recorded to understand how it relates to the primary outcome (continence). Bowel function will be determined by asking a series of questions previously described in a clinical trial of post-prostatcetomy incontinence:
1 - How often do you lose control of or leak stool? (Never, Occasionally, Some of the time, Most of the time, All of the time)
2 - If you do, how much does this bother you? (Between 0 - Not at all to 10 - A great deal)
3 - When you feel the need to open your bowels, do you have to rush urgently to the toilet? (Never, Occasionally, Some of the time, Most of the time, All of the time)
4 - When you have to rush urgently, do you ever lose control of or leak stool? (Never, Occasionally, Some of the time, Most of the time, All of the time)
5 - Did you ever lose control of or leak stool BEFORE your prostate surgery? (Yes/No)
6 - Do you have any of these other bowel problems? ([Tick box] Ulcerative colitis, Crohn’s disease, Irritable bowel syndrome, Constipation)
Timepoint [9] 346337 0
Measured at baseline, then at weekly intervals from week of catheter removal until 3 months. The measure will be collected once more at 12 months.
Secondary outcome [10] 369875 0
Treatment adherence will be will be recorded to understand how it relates to the primary outcome (continence). A study-specific online questionnaire will be used with the following questions:

In the past week, approximately how many days did you do your pelvic floor muscle exercises?

On a typical day in this past week that you did pelvic floor exercises, how many pelvic muscle contractions did you do?

During the past month, approximately how many days did you do your pelvic-floor muscle exercises?

On a typical day in this past month that you did pelvic floor exercises, how many pelvic muscle contractions did you do?

Was it hard to find the time to do all of the exercises? (Yes / No / Unsure)

Were you unsure if you were doing the exercises correctly? (Yes / No / Unsure)

Did the exercises cause any pain? (Yes / No / Unsure)

Did you have trouble remembering to do the exercises? (Yes / No / Unsure)

Did it seem as if the exercises were not helping your incontinence? (Yes / No / Unsure)

Were you so much better that you felt that you did not need to continue the exercises? (Yes / No / Unsure)

Are there any other reasons why you did not do the exercises? (Yes / No )

Did you contract your pelvic floor muscles to prevent urine from leaking when you performed a functional activity or coughed? (Yes / No / Unsure)
Timepoint [10] 369875 0
Starting at the week of catheter removal and continuing monthly until 12 months.

Eligibility
Key inclusion criteria
Men scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Men will be included if they are able to attend assessment and rehabilitation sessions and are able to understand English.
Minimum age
30 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Main exclusion criteria are: (i) urinary incontinence prior to surgery; (ii) previous prostate or urethral surgery, (iii) assessment/training of pelvic floor muscles in preceding 6 months, (iv) scheduled to undergo or had previously undergone radiation therapy for prostate cancer.

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 in permuted blocks, stratified by surgeon and baseline neuro-muscular control of urethral pressure (patients dichotomised as good [or poor] by ability to achieve both greater than or equal to 4.1 mm dorsal displacement of the mid-urethra (striated urethral sphincter) and greater than or equal to 2.4 mm of urethro-vesical junction elevation (puborectalis). Different physiotherapists will provide the two training programs. Group allocation will be determined using an automatic randomisation schedule developed by an independent statistician and integrated into the REDCap data administration system (see below) to ensure concealed allocation. Assessors and statisticians will be blinded to group allocation. It will not be possible to blind the participant or treating therapist to the treatment, but patients will be blinded to the hypotheses.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Primary outcome is the proportion of participant’s continent at 3 months. This was selected as, qualitative research highlights that rapid/complete recovery of continence is a priority for men, and it was considered unethical to withhold treatment from men allocated to No training for more than 3 months if they continue to experience incontinence. This study is powered to determine whether the Urethral training is more efficacious than Conventional and No training, and whether this effect is moderated by baseline neuromuscular (NM )control of urethral pressure. Data from seven RCTs indicate ~60% of men receiving Conventional training will be incontinent at 3 months. Our data of healthy men suggest 55% have “good” NM control at baseline. We make the assumption that among those with good NM control at baseline, incontinence outcomes at 3 months will be similar regardless of their treatment assignment. Using the estimate of reduction of incontinence by a third to 40% of men at 3 months (based on the difference identified in previous study, which included some features we consider critical in the proposed program), with 80% power and two-sided significance level of 0.05 we need 97 men per group. With this number of participants we have 88% power to detect a significant interaction between baseline NM control and treatment arm if we assume that 30% men with good NM control at baseline will be incontinent at 3 months regardless of treatment, but that, of the men with poor NM control at baseline, 90% and 50% will be continent with urethral or conventional training, respectively. We will recruit 121 men per arm (adjusting for a potential drop-out rate of 20%).
Statistical analysis: A biostatistician will analyse blinded data, with all patients enrolled and randomised to treatment/no treatment arms comprising the data set for analysis. Baseline characteristics of groups will be tabulated using summary statistics. Multiple imputation will be used to account for missing data, with missing data imputed using logistic regression models for binary outcomes and predictive mean matching for continuous outcomes.
Primary analysis: For the continence outcome, a hierarchical logistic regression model including random effects to account for multiple measurements per participant, and random effects for surgeon, will be fit. This model will include a three-way interaction term between time, randomised treatment group, and baseline NM control, and all two-way interactions and main effects, as well as the stratifying variable of site. For the primary hypothesis, this model will be interrogated to yield differences in the proportions of participants recovering continence at 3 months between the groups and 95% confidence intervals. The model will be similarly interrogated to determine whether the effect of urethral training relative to conventional training is moderated by NM control of urethral pressure at baseline. Post-operative NM control measures will be considered in a secondary analysis.
Secondary analyses: The continuous measure of continence (24-hour pad test weight) and other continuous outcomes (ICS-male short, SF12) will be compared between groups by fitting a similar random effects linear regression model. Time to recovery of continence will be compared between groups using a Cox proportional hazards model using weekly 24-hr pad test. Model assumptions (linearity, normality and homoscedasticity of residuals for the linear regression models) and the Cox proportional hazards assumption will be assessed using standard diagnostic plots.
Mediation analysis: To determine the extent to which the effect of urethral training program on the primary outcome and on the continuous measurement of continence is mediated through an improvement in NM control, as hypothesised, we will apply a causal mediation analysis. Mediation analyses will be conducted for the NM control measure recorded at week 6 and month 3, with all analyses adjusted for baseline levels of NM control and other potential confounders of the outcome-mediator relationship. The analysis will be conducted in two stages: at the first stage, the effect of randomisation to the study arms on NM control measures will be assessed. Those measures that differ between groups will then be carried forward to the second stage of the analysis. In this second stage, models will be fit to estimate the direct effect of randomised group on outcome and the indirect effect of randomised group on the outcome that acts through the putative mediator. Whether the indirect effect of treatment on the outcomes changes depending on the level of NM control achieved after surgery will be investigated through the inclusion of interaction terms between treatment group and post-surgery NM control variables in the mediation analyses.
If significant mediation is found, logistic regression will be undertaken using the 3 month data of the NM control variables to determine which variables are best linked with continence. A factor analysis across all participants will be applied to extract common NM control features from the NM control variables. NM control features are then used as predictor variables in the logistic regression analysis to assess the relative contribution of each to the odds of regaining continence. This analysis would enable generation of an equation that predicts the probability of continence given the level of the measured NM control features, and therefore the amount of change that is required in individual features of NM control to achieve continence. This equation would have high clinical utility for targeting/prioritisation of treatment.
Cost effectiveness analysis: Costs of services and devices will be estimated using market prices. We will undertake two analyses at 3 and 12 months. First we will compare cost effectiveness between trial arms. Second we will address the question of whether treatment is more cost effective if only offered to men with poor NM control at baseline. For this analysis we will test the interaction between treatment arm and baseline NM control. This will test the hypothesis that continence-related costs will be similar for men with good NM control, regardless of treatment allocation, but costs will be significantly less for men with poor baseline NM control allocated to Urethral training. Quality-adjusted life-years saved (QALYs) will be computed using the EQ-5D-5L data collected from the trial. Cost-effectiveness ratios will be computed and n-way sensitivity analyses will be conducted to produce cost effectiveness acceptability curves for relevant sets of assumptions about costs and outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
27/07/2018
Date of last participant enrolment
Anticipated
1/07/2021
Actual
22/12/2022
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
363
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7483 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7484 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 15306 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 15307 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 295622 0
Government body
Name [1] 295622 0
Queensland Health
Country [1] 295622 0
Australia
Funding source category [2] 302648 0
Government body
Name [2] 302648 0
National Health and Medical Research Council of Australia
Country [2] 302648 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Therapies Building 84A
The University of Queensland
St Lucia, Queensland
4072
Country
Australia
Secondary sponsor category [1] 294463 0
None
Name [1] 294463 0
Address [1] 294463 0
Country [1] 294463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296943 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 296943 0
Ethics committee country [1] 296943 0
Australia
Date submitted for ethics approval [1] 296943 0
15/06/2017
Approval date [1] 296943 0
08/11/2017
Ethics approval number [1] 296943 0
2017001736
Ethics committee name [2] 296945 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [2] 296945 0
Ethics committee country [2] 296945 0
Australia
Date submitted for ethics approval [2] 296945 0
15/06/2017
Approval date [2] 296945 0
07/11/2017
Ethics approval number [2] 296945 0
UnitingCare HREC 1739
Ethics committee name [3] 297778 0
Metro South Human Research Ethics Committee
Ethics committee address [3] 297778 0
Ethics committee country [3] 297778 0
Australia
Date submitted for ethics approval [3] 297778 0
15/06/2017
Approval date [3] 297778 0
28/11/2017
Ethics approval number [3] 297778 0
HREC/17/QPAH/591

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72498 0
Prof Paul Hodges
Address 72498 0
Therapies Building 84A
The University of Queensland
St Lucia, Queensland
4072
Country 72498 0
Australia
Phone 72498 0
+61 7 3365 2008
Fax 72498 0
Email 72498 0
p.hodges@uq.edu.au
Contact person for public queries
Name 72499 0
Ryan Stafford
Address 72499 0
Therapies Building 84A
The University of Queensland
St Lucia, Queensland
4072
Country 72499 0
Australia
Phone 72499 0
+61 432712145
Fax 72499 0
Email 72499 0
r.stafford@uq.edu.au
Contact person for scientific queries
Name 72500 0
Ryan Stafford
Address 72500 0
Therapies Building 84A
The University of Queensland
St Lucia, Queensland
4072
Country 72500 0
Australia
Phone 72500 0
+61 7 3346 7751
Fax 72500 0
Email 72500 0
r.stafford@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Requests for data sharing will be considered on a case by case basis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
41Study protocol    Study protocol is now in press at BMJ Open.



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): Protocol for a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-028288
N.B. These documents automatically identified may not have been verified by the study sponsor.