Reviewer ’s report  
 
Title: Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a 
mixed methods pilot for a randomised controlled trial  
 
Version: 0 Date: 17 Jan 2017  
 
Reviewer: Stephanie Madill  
 
Reviewer's report:  
 
Overall this is a well written manuscript. The study is interes ting, largely well designed and adds 
to our understanding of conservative treatment for urinary incontinence in women.  
I have two major concerns regarding the manuscript. My first concern is that the statistical 
analyses and results do not follow the state d aims of the study. My second concern is that this 
study includes several significant limitations that are not addressed by the authors. I have 
detailed the specifics of these concerns below.  
 
1) Results: You list the four aims of this study at the end of the Background section (page 5, 
lines 8 through 13). You do not identify which outcome measure(s) address each aim. Please 
make this clear.  
The description of the statistical analyses is insufficient. Please describe both the tests used and 
why they were chosen. As well, the specific tests used is given in the results section for several 
tests. They should be in the methods.  
Why did you test the reliability of the questionnaires? Which aim did these tests address? Please 
justify their inclusion.   
I under stand why you stratified the participants for randomisation, but I do not understand why 
you performed the primary analyses on the stratified data. I would suggest that you first present 
your between group results on the whole study sample, and then look a t the stratified data as post 
hoc tests. Alternately, you could perform an analysis to look for a group by stratum interaction.  
I do not understand the sentence: "Analyses of subgroups such as patients with low/high SSI and 
QoL were also undertaken in acco rdance with the study protocol."  
As there were a fair number of drop outs, please repeat the baseline characteristic comparison for 
only those who completed the study. It is important to know if the groups were still comparable.  
I do not understand the re sults that report the trends towards higher QoL and less social impact. 
Are these as a result of the intervention or just a between group difference? If they are a between 
group difference, to which group were they compared?  
 
2) Limitations: Please include the mean/median number of SPC sessions completed by each 
group. Also, please include the mean/median length of time between the first and last 
sessions. A significant limitation of this study is the inequality, in terms of contact time with 
the physios and  in group support, between the groups. This information needs to be provide 
so that the reader can evaluate the difference between the two interventions.  
For the SPC group, a minimum of three sessions in three months seems insufficient. The strength 
traini ng literature advices that at least 12 weeks of overload training is required to produce 
strength gains. It is not clear that the SPC intervention was of sufficient intensity to produce 
benefit. Please discuss.   
A primary rationale for undertaking this st udy was that adding modified Pilates to PMFT would 
increase motivation and adherence. The results of this pilot do not seem to support that 
supposition as there were more drop outs in the Pilates group than in the control. This limitation 
needs to be addre ssed.  
The ICS recommends that both assessment of leakage and patient reported measures be collected 
to assess the effects of interventions for urinary incontinence. The authors state that they did not 
perform a pad test or other direct measure of leakage b ecause it would have increased participant 
burden. How would this sort of test increase burden? As most intervention trials include a 
measure of leakage, not including one here limits the ability to compare this study to other 
intervention trials. Please d iscuss.  
 
Minor Concerns:  
1) The number and ages of participants belong in the results section, not the methods.  
 
2) What is the Public and Patient Involvement Group?  
 
3) What is the NRES?  
 
4) I think that on page 8, line 10, you mean palpation not palpitatio n. 
 
5) Please provide an appendix with the descriptions of the modified Pilates exercises.  
 
6) What was the length of time between SPC session 1 and session 2?  
 
7) In the text you talk about the descriptive statistics in terms of mean and standard error, but on 
the tables you give mean and standard deviation. Which is it?  
 
8) In the text you state that you removed 24 women (14 intervention and 10 control) from the 
full analyses, while on the flow chart it states that that many women dropped out. Please 
make the two sources consistent.  
 
9) On Table 2, you need to provide a legend to define all the abbreviations.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Unable to assess  
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now o r in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to th e content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have no competing interes ts' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
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