Reviewer ’s report  
 
Title: Clinical Pilot Study to Evaluate the Neovaginal PACIE NA Prosthesis® for Vaginoplasty 
without Skin Grafts in Women with Vaginal Ag enesis.  
 
Version: 0 Date: 03 Jun 2019  
 
Reviewer: Marilene Vale de Monteiro  
 
Reviewer's report:  
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Dear authors:  
The study is interesting and presents relevant aspects such as:  
 - the use of  hollow prosthesis made of Poly -lactic Acid  
- a less painful prosthesis fixation system in vaginal introitus  
- use of less rigid prosthesis with better vaginal adaptation  
- use of 3D printer.  
 
However, there are events that need to be better clarified:  
Five patients underwent surgery at the hospital  1: four of these patients developed Pseudomonas 
infection and three had postoperative complications. The authors should have explained whether 
or not the surgeons were experienced and if pre and post -operative care was given like at hospital 
2, particular ly in relation to the prosthesis.  
On line 213 the authors reported that this technique required a shorter hospitalization period, 
with a good anatomical and functional result of the vagina. However, the average time of 
hospitalization was 7 days, and only two patients had sexual intercourse after surgery (and one of 
them started sexual activity at the end of the postoperative follow -up). So this observation is 
weak.  
With respect to the anatomical result, the vaginal length at the three months of follow -up exam 
was 9.2 cm which confirms a good result. However, I need to ask why vaginal length was not 
measured in patients C5 and C7 at the 6 -month follow -up? 
The authors were careful to verify the epithelization of the neovagina in the postoperative period. 
, however, there is no way to attribute this good result to the use of the PACIENA prosthesis. It 
has already been shown that Interceed causes good epithelization when used in vaginoplasty and 
it was placed in direct contact with the neovagina tunnel in this study, unlike the prosthesis.  
Regarding clinical relevance, the authors cannot state that the PLA prosthesis stimulates 
epithelization. The conclusion should be reviewed. There is no way to prove that the patients in 
this study had good functional results,  but I agree that they had a good anatomical result. The last 
two paragraphs of the conclusions should be omitted, but could be used in the discussion.  
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
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.  
 
No 
 
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.  
 
Not relevant to this manuscript  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
 
 
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