Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women

Tae Yeon Kim; Myung Jae Jeon

doi:10.1371/journal.pone.0228566

Peer Review History

Original SubmissionOctober 3, 2019
5 Dec 2019 Decision Letter - Antonio Simone Laganà, Editor PONE-D-19-27662 Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women PLOS ONE Dear Dr. Jeon, 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. We would appreciate receiving your revised manuscript by Jan 19 2020 11:59PM. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. 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Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments (if provided): The topic of the manuscript is interesting. Nevertheless, the reviewers raised several concerns: considering this point, I invite authors to perform the required major revisions. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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 ****** 4. 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: No ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I was pleased to revise the manuscript entitled “Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women” (Manuscript Number: PONE-D-19-27662). The study approval was viewed by the institutional review board of Seoul National University Hospital (No. 1907-045-1046). In general, this manuscript was aimed to identify risk factor for mesh erosion in women underwent sacrocolpopexy type 1 polypropylene mesh. In my honest opinion, the topic is interesting enough to attract the readers’ attention. Methodology requires to be improved, although conclusions are supported by the reported data. Nevertheless, authors should clarify some point and improve the discussion citing relevant and novel key articles about the topic. In general, the Manuscript may benefit from several major revisions, as suggested below: 1. I would suggest a revision of the manuscript language to improve some typos and readability in some sections. 2. Abstract. The statement “in spite of the use of type 1 polypropylene mesh” cannot be supported by the study results because all women underwent correction with the same mesh. 3. The statistical methods are not clear. How was the erosion rate estimated using Kaplan-Meier curves? If it refers to the hazard ration of erosion, it is more appropriate the cox analysis. I would suggest checking this section and improving description. 4. Were some specific inclusion and exclusion criteria used? 5. Table 2. I would suggest reporting the line with HR of 1 indicating the group of reference. Regarding the surgeon experience, does it include the firs surgical procedure? 6. Based on the possible age factor related to estrogen exposure as risk factor for erosion, I would suggest test the age as confounding factor in the multivariate analysis. 7. Lines 165-166. I would suggest use the appropriate term for the described bias, such as attrition bias. Moreover, the use of cox analysis cannot identify differences that may be linked to risk of erosion and the lost at follow-up. The main way is to evaluate if the characteristics of patients lost at follow-up are comparable with followed up women. 8. Discussion. I would suggest discussing, at least briefly, the key role of a multidisciplinary approach for the management of patients with pelvic organ prolapse (DOI: 10.5114/pm.2019.89496). 9. As highlighted by the study results, 8% of women developed mesh erosion and 68% of them underwent surgery. In addition to the treatment of mesh erosion, the recurrence of pelvic organ prolapses may be a complex procedure. Indeed, although several approaches are able for the management of POP, the best strategy in case of recurrence after vaginal vault prolapse still remains debated. I would discuss, at least briefly, the available evidence about novel techniques, referring to: PMID: 29675427; PMID: 29038834. ****** 6. 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 [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files to be viewed.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0228566.r001
Revision 1
16 Dec 2019 Author Response Dear Antonio Simone Laganà, Academic Editor of PLOS ONE, Thank you very much for the review of our manuscript. The comments were excellent and helpful, and were good guides for revising and improving our manuscript. The following is an itemized account of the changes in the manuscript made in response to the comments. Journal Requirements: 1. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. -> We added caption for our supporting information file at the end of the manuscript. Reviewers' comments: Reviewer #1: I was pleased to revise the manuscript entitled “Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women” (Manuscript Number: PONE-D-19-27662). The study approval was viewed by the institutional review board of Seoul National University Hospital (No. 1907-045-1046). In general, this manuscript was aimed to identify risk factor for mesh erosion in women underwent sacrocolpopexy type 1 polypropylene mesh. In my honest opinion, the topic is interesting enough to attract the readers’ attention. Methodology requires to be improved, although conclusions are supported by the reported data. Nevertheless, authors should clarify some point and improve the discussion citing relevant and novel key articles about the topic. In general, the Manuscript may benefit from several major revisions, as suggested below: 1. I would suggest a revision of the manuscript language to improve some typos and readability in some sections. -> We edited English. 2. Abstract. The statement “in spite of the use of type 1 polypropylene mesh” cannot be supported by the study results because all women underwent correction with the same mesh. -> We revised the sentence. 3. The statistical methods are not clear. How was the erosion rate estimated using Kaplan-Meier curves? If it refers to the hazard ration of erosion, it is more appropriate the cox analysis. I would suggest checking this section and improving description. -> Kaplan-Meier survival analysis presents the estimated cumulative erosion rates as well as survival curve. Therefore, we can obtain the estimated erosion rates with the use of the Kaplan-Meier method. 4. Were some specific inclusion and exclusion criteria used? -> No. We included all patients who had undergone SCP for symptomatic POP at the Seoul National University Hospital between November 2008 and June 2018 except for 3 women who did not attend any follow-up visit. 5. Table 2. I would suggest reporting the line with HR of 1 indicating the group of reference. Regarding the surgeon experience, does it include the first surgical procedure? -> We revised Table 2 according to your recommendation. We included the whole SCP to evaluate the effect of surgeon’s experience on the mesh erosion (even though the surgeon completed urogynecologic fellowship training course and acquired skill for SCP). 6. Based on the possible age factor related to estrogen exposure as risk factor for erosion, I would suggest test the age as confounding factor in the multivariate analysis. -> We intentionally excluded age from the multivariate analysis because of the close relationship between age and estrogenic status (younger women are more likely to premenopausal and take ERT to control their vasomotor symptoms). Statisticians recommended us not including age in the multivariate analysis. In addition, when we included both age and estrogenic status in the multivariate analysis, estrogenic status, not age, was an independent risk factor for vaginal mesh erosion. 7. Lines 165-166. I would suggest use the appropriate term for the described bias, such as attrition bias. Moreover, the use of cox analysis cannot identify differences that may be linked to risk of erosion and the lost at follow-up. The main way is to evaluate if the characteristics of patients lost at follow-up are comparable with followed up women. -> We revised the sentence. There are various reasons for follow-up loss: from no specific discomfort to disappointment to the surgical outcomes (recurrence of POP or complications). To avoid attribution bias, we can contact the patients by phone. However, mesh erosion does not always cause problems such as vaginal bleeding, discharge, and dyspareunia. Therefore, patients should be examined in the office to evaluate the occurrence of mesh erosion. In addition, mesh erosion rates increase over time, and there is no acceptable cut-off time to evaluate the occurrence of mesh erosion. We think that the use of Cox proportional hazard model is the best way to evaluate the risk factors for vaginal mesh erosion making the most efficient use of the data in this retrospective study. 8. Discussion. I would suggest discussing, at least briefly, the key role of a multidisciplinary approach for the management of patients with pelvic organ prolapse (DOI: 10.5114/pm.2019.89496). -> We carefully read the article entitled to “Multidisciplinary management of women with pelvic organ prolapse, urinary incontinence and lower urinary tract symptoms. A clinical and psychological overview”. That article deals with a multidisciplinary approach for female sexual dysfunction, which is beside the point of our manuscript (The aim of our study was to evaluate the risk factors for vaginal mesh erosion after SCP). 9. As highlighted by the study results, 8% of women developed mesh erosion and 68% of them underwent surgery. In addition to the treatment of mesh erosion, the recurrence of pelvic organ prolapses may be a complex procedure. Indeed, although several approaches are able for the management of POP, the best strategy in case of recurrence after vaginal vault prolapse still remains debated. I would discuss, at least briefly, the available evidence about novel techniques, referring to: PMID: 29675427; PMID: 29038834. -> We agree with your opinion. The use of mesh can reduce the recurrence of POP while it can give rise to various complications including mesh erosion. Nonetheless, current scientific evidences support that SCP using type 1 polypropylene mesh is appropriate for women with risk factors for prolapse recurrence. Our study found that premenopausal and postmenopausal women, known at high risk for the recurrence of POP, have increased risk for vaginal mesh erosion. We would like to highlight this point. We read the articles (recommended by you) entitled to “Transvaginal Bilateral Sacrospinous Fixation after Second Recurrence of Vaginal Vault Prolapse: Efficacy and Impact on Quality of Life and Sexuality” and “The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis”. The latter article is in accord with our manuscript, but it seems better to cite it in the introduction section rather than discussion section (because the aim of that study was to compare the effectiveness and safety among various vaginal vault suspension procedures, rather than to evaluate the risk factors for mesh erosion after SCP). We cited that article as reference 7 in the introduction section. Attachments Attachment Submitted filename: Response to reviewers comments.docx https://doi.org/10.1371/journal.pone.0228566.r002
21 Jan 2020 Decision Letter - Antonio Simone Laganà, Editor Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women PONE-D-19-27662R1 Dear Dr. Jeon, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. 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With kind regards, Antonio Simone Laganà, M.D., Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Authors performed the required corrections, which were positively evaluated by the reviewer. I am pleased to accept this paper for publication. Consider that the appropriate term for the bias is “attrition” and not “attribution”. Please change it or leave just selection bias. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I was pleased to revise the manuscript entitled “Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women” (Manuscript Number: PONE-D-19-27662). The study approval was viewed by the institutional review board of Seoul National University Hospital (No. 1907-045-1046). In general, this manuscript was aimed to identify risk factor for mesh erosion in women underwent sacrocolpopexy type 1 polypropylene mesh. In my honest opinion, the topic is interesting enough to attract the readers’ attention. The authors addressed almost all the suggested revisions, and I appreciated the manuscript improvement. The appropriate term for the bias is “attrition” and not “attribution”. Please change it or leave just selection bias. ****** 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 https://doi.org/10.1371/journal.pone.0228566.r003
Formally Accepted
23 Jan 2020 Acceptance Letter - Antonio Simone Laganà, Editor PONE-D-19-27662R1 Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women Dear Dr. Jeon: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Antonio Simone Laganà Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0228566.r004

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