PONE-D-21-07963

EFFECT OF RADIOFREQUENCY AND PELVIC FLOOR MUSCLE TRAINING IN THE TREATMENT OF WOMEN WITH VAGINAL LAXITY: A STUDY PROTOCOL

PLOS ONE

Dear Dr. Brito,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. You should address the reviewers comments, and also include in the abstract the outcome measures (at least the primary outcome). 

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Jose María Blasco, Ph.D.

Academic Editor

PLOS ONE

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Additional Editor Comments (if provided):

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Partly

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: No

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: No

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Line 52. Abstract � It is not recommended to use acronyms directly without having explained them beforehand and this makes the abstract difficult to read. In this case, the action that each of the two groups is going to carry out is not clear.

Line 52. Introduction � The data presented in this section are correct, however, it is necessary to restructure this section because the thread of the reading is lost, not making clear until the end what one wants to study. It is also necessary to delve a little into the benefits of the different non-surgical actions in this pathology, in order to correctly guide the introduction.

Line 119. Introduction � The secondary objectives are somewhat confusing, they seem like a simple list, please rewrite this point to make it clearer.

Line 131. Trial design � Why is an assessment not carried out immediately after the intervention? It would be interesting to see if there is any kind of change in that phase.

Line 171. Study population � Why not put a roof or old cut? Are the same results expected in the elderly as in the adult, for example?

Line 192. Eligibility criteria � Data already exposed are repeated with the study population section, please review it.

Line 301. Procedure � Is rest time allowed between exercise and exercise? If yes, how long is this break?

Line 326. Primary outcomes� Is the proposed scale validated? Some more explanation of the main variable of the study is missing, since it is not clear.

Line 326 to 402. Outcomes (primary and secondary) � It would be interesting to provide the interrater and test-retest reliability data for all the variables.

Line 419. Follow-up Period Assessment � indicate that the measurements are from the end of the intervention.

Line 430 � It would be convenient to name the years of experience that the researchers who carry out both the intervention and the data collection have.

Line 461 � Indicate version of the SPSS program

Line 449. Data analysis � This is considered a non-inferiority work, please indicate it and explain in this section how it will be verified.

Line 542. References � Please keep the same line spacing as the rest of the article.

Reviewer #2: A study protocol entitled „EFFECT OF RADIOFREQUENCY AND PELVIC FLOOR MUSCLE TRAINING IN THE TREATMENT OF WOMEN WITH VAGINAL LAXITY: A STUDY PROTOCOL” has interesting topic and currently scoping.

Some methodological inacurracies should be addressed before the paper can be considered for publication.

Major

1. Describe the rationale for using a non-inferiority design of the study.

2. What are study objectives? What kind of effects of radiofrequency and pelvic floor muscle training are expected by the authors?

3. Please justify the established efficiency of PFMT in Vaginal Laxity

4. Where is the first visit taking place? Is the assessor going to be blindfolded?

5. Line 210-222

Authors wrote: „The numbers corresponding to the study groups (1. Radiofrequency and 2. Pelvic Floor Muscle Training) will be placed in opaque sealed envelopes that will be opened by the study participants after signing the consent form and undergoing initial assessment or first clinical visit.”

Will the participants know the group they are allocated to after signing the consent form and undergoing initial assessment or first clinical visit ?

6. Line 223-225

Is the person performing physical examination of PFMbe going to be blindfolded or is it going to be the same person conducting Pelvic Floor Muscle Training ? Which centre are PFM trainings going to be conducted in?

7. Line 374

Will Pelvic Organ Prolapse Quantification (POP-Q) be the procedure to compare the efficacy of two treatment methods? Will Pelvic Organ Prolapse Quantification (POP-Q) be used as criteria of exclusion? In lines 196 - 202 the authors state: Participants who present the following conditions will be excluded from the study: ……patients with stage 2 POP onwards;…”

8. Please describe in detail how the vaginal wall thickness measurements will be defined and how they will be performed by transvaginal and transabdominal USI.

9. Line 393

Which method will be used for morphometry of PFM? Which ultrasound parameters will be assessed?

10. Are all USI examinations going to be performed by the same examiner ?

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

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EFFECT OF RADIOFREQUENCY AND PELVIC FLOOR MUSCLE TRAINING IN THE TREATMENT OF WOMEN WITH VAGINAL LAXITY: A STUDY PROTOCOL

PONE-D-21-07963R1

Dear Dr. Brito,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Jose María Blasco, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear authors,

After reviewing the corrections, it has been observed that all suggested changes have been noted to have been corrected or a rational response to the proposed suggestion justified.

Both the design and the language of the article are considered to be more than correct.

In addition, the article is considered to meet the minimum standards of the journal for publication.

finally indicate that for my part it is not necessary to make any additional changes.

Sincerely

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No