Title: INTRAVAGINAL NONABLATIVE RADIOFREQUENCY IN THE TREATMENT
OF GENITOURINARY SYNDROME OF MENOPAUSE SYMPTOMS: A SINGLE-ARM
PILOT STUDY
Version: 4 Date: 08 Mar 2021
Reviewer's report:
Recommendation
Major Revision
Comments to Author:
Ref: Submission ID 08eb4c16-f597-4a7c-9fc9-f2ac8986bad4
Title: INTRAVAGINAL NON ABLATIVE RADIOFREQUENCY IN THE TREATMENT OF
GENITOURINARY SYNDROME OF MENOPAUSE SYMPTOMS: A PHASE I CLINICAL
TRIAL
Overview and general recommendation:
The manuscript had an interesting topic and is a very important one. The authors researched the
effect of RF in Genitourinary Syndrome of Menopause (GSM) symptoms among menopausal
women. This study could help us to understand the effect of nonablative RF in several
menopausal symptoms and shows a possible effective method to treat it. However, I have some
comments.
First, the manuscript needed an English revision, it has many grammatical errors and makes
the text difficult to read. My second comment is regarding the abbreviation along with the
manuscript. Several times the authors abbreviate and along the text return to using the extended
form of the word. Once an abbreviation has been defined, it is appropriate to use it throughout,
to ensure consistency. Finally, ensure you used one decimal place after the comma, following
the International System of Units (SI).
I felt confident that the authors performed carefully and used reliable and replicable
measurement instruments. On the other hand, I found some of the description of the paper to be
too detailed, while the descriptions of some very important points were inadequate or completely
missing. Therefore, I recommend that a major revision is warranted. I explain my concerns in
more detail below. I ask that the authors specifically address each of my comments in their
responses.
Title
I recommend change “A PHASE I CLINICAL TRIAL” to “PILOT STUDY”.
The authors performed a pilot study. Phase I trials aim to find the best dose of a new method
with the fewest side effects. You used only one dose in all participants. So, you performed a
Phase 0 or a pilot study.
Introduction
Your introduction section was well described, you write good background information regarding
the GSM. In this section, the authors should answer the question ‘Why:’ why you choose that
topic for research; why it is important; why you adopted the RF as a method? My suggestion
is the authors add information about that! why it is important; why you adopted the RF as a
method? what would be the effects of RF on GSM?
Methods section
In my opinion, this section needs a little attention to not lead to inconsistency.
In the description of the instruments, you need to add more details.
- The Vaginal Health Index (VHI), is a graduate scale (1-5) for several items. You explain how
the ph was assessed. However, we do not know what is the PH value that you adopted “as
normal”? what do the values represent? To the other variables: vaginal elasticity, fluid volume,
epithelium integrity, and humidity. How were assessed?? You MUST insert information to be
able to replicate!
- The Vaginal Maturation Index (VMI): You performed a cytological analysis? How? was tissue
biopsy performed? What is the sample size? how was the procedure performed?
- In the description of the FSFI, QS-F, and ICIQ-SF please insert the references of the validated
questionnaires.
Results and Discussion sections
In my opinion, you will need to add some points in the discussion section that will reflect on
the results section.
In your first paragraph, you state that “We found an improvement in genitourinary signs and
symptoms…” But, you can not generalize all variables. Some showed no improvement. Please,
be more careful.
Analyzing the results tables, I noticed that several women had an improvement in FSFI and VHI
indicators in the first month, but decreased in the fifth month. In my point of view, this is very
important to discuss. why do you think it happened? are the effects of the RF short-term?
I do not understand your statement “…. In our study, 66.7% and 83.8% improved urinary
symptoms, one and three months after treatment,…” Please, rewrite the sentence.
Also, when you are writing about UI and RF, previous studies have been demonstrated that RF
can be a good alternative for SUI. I would like to know what type of UI was found in your study?
All women had SUI? In addition, one woman from your study develop UI after the treatment,
how do you explain this effect?
My other suggestion is to improve the limitation section and add a section about the study
strength.
Finally, your clinical application and conclusion sections must be drawn according to the main
of the study. Please, rewrite.