Reviewer’s report
Title: 
Clinical Effectiveness and Safety of Self-expandable Implantabel Bulking
Agents for Faecal Incontinence: A Systematic Review
Version: 
1 
Date: 
29 Jan 2022
Reviewer: 
Anne S Leroi
Reviewer's report:
Clinical Effectiveness and safety of implantable bulking agents for faecal
incontinence: a systematic review
BMC Gastroenterology : BMGE-D-21-0079R1
This is a review of prospective studies concerning implantable prostheses for
fecal incontinence requested as part of an application for reimbursement of the
device. The methodology used seems adequate to me and the review is of
quality. This study answers a relevant question about a new treatment for which
clinicians still have questions.
I have only few comments and concerns:
The name of the medical device used is confusing. In the title and the
introduction, the reader may think that bulking agents (solesta, bulkamid etc..)
and implants will be taken into account and compare. This is reinforced by the
paragraph on the bulking agents in the introduction which should be removed
and the aim of the study " this review aims to evaluate whether implantable
bulking agents are superior to injectable bulking agents.."
The term self-expandable prostheses or the trade name Sphinkeeper/Gatekeeper
would be more explicit.
This review was done 1 year ago. Prospective studies have been published since:
an update would be useful.
I find the manuscript too long with repetitions: physiopathology of FI,
implantation technique in introduction; definition of FI in discussion; 
results in
discussion, conclusion etc.. not focused enough on the essential message.
Is it possible to have more informations about unpublished studies ?
In the limitations section, the limitations of the studies are described, not those of
the review. The limitations of the study should be summarized: prospective
studies only taken into account, no comparison of sphinkeeper and gatekeeper,
no consideration of delay to delay defecation etc
Minor remarks:
Page 6, line 18: was conducted 14/01/2021
Reference for PICOS schema ?
Why separate clinical effectiveness FI severity and sustainability of FI severity ?
gathering these informations would be easier to read and avoid repetitions.
Section Disease-related quality of life, line 41 : QOL was assessed by .. already
mentioned in methods.
Section Disease-related quality of life, line 56 106,0; p<0.001) number of
patients ?
Publons Reviewer Recognition
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a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
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No
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
or 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 the 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
interests' below. If your reply is yes to any, please give details below.
No competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please publish my name with my
report.
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Reviewer’s report
Title: 
Clinical Effectiveness and Safety of Self-expandable Implantabel Bulking
Agents for Faecal Incontinence: A Systematic Review
Version: 
1 
Date: 
29 Jan 2022
Reviewer: 
Anne S Leroi
Reviewer's report:
Clinical Effectiveness and safety of implantable bulking agents for faecal
incontinence: a systematic review
BMC Gastroenterology : BMGE-D-21-0079R1
This is a review of prospective studies concerning implantable prostheses for
fecal incontinence requested as part of an application for reimbursement of the
device. The methodology used seems adequate to me and the review is of
quality. This study answers a relevant question about a new treatment for which
clinicians still have questions.
I have only few comments and concerns:
The name of the medical device used is confusing. In the title and the
introduction, the reader may think that bulking agents (solesta, bulkamid etc..)
and implants will be taken into account and compare. This is reinforced by the
paragraph on the bulking agents in the introduction which should be removed
and the aim of the study " this review aims to evaluate whether implantable
bulking agents are superior to injectable bulking agents.."
The term self-expandable prostheses or the trade name Sphinkeeper/Gatekeeper
would be more explicit.
This review was done 1 year ago. Prospective studies have been published since:
an update would be useful.
I find the manuscript too long with repetitions: physiopathology of FI,
implantation technique in introduction; definition of FI in discussion; 
results in
discussion, conclusion etc.. not focused enough on the essential message.
Is it possible to have more informations about unpublished studies ?
In the limitations section, the limitations of the studies are described, not those of
the review. The limitations of the study should be summarized: prospective
studies only taken into account, no comparison of sphinkeeper and gatekeeper,
no consideration of delay to delay defecation etc
Minor remarks:
Page 6, line 18: was conducted 14/01/2021
Reference for PICOS schema ?
Why separate clinical effectiveness FI severity and sustainability of FI severity ?
gathering these informations would be easier to read and avoid repetitions.
Section Disease-related quality of life, line 41 : QOL was assessed by .. already
mentioned in methods.
Section Disease-related quality of life, line 56 106,0; p<0.001) number of
patients ?
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
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
or 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 the 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
interests' below. If your reply is yes to any, please give details below.
No competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please publish my name with my
report.
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Please review this paper.
user
Reviewer’s report
Title: 
Clinical Effectiveness and Safety of Self-expandable Implantabel Bulking
Agents for Faecal Incontinence: A Systematic Review
Version: 
1 
Date: 
29 Jan 2022
Reviewer: 
Anne S Leroi
Reviewer's report:
Clinical Effectiveness and safety of implantable bulking agents for faecal
incontinence: a systematic review
BMC Gastroenterology : BMGE-D-21-0079R1
This is a review of prospective studies concerning implantable prostheses for
fecal incontinence requested as part of an application for reimbursement of the
device. The methodology used seems adequate to me and the review is of
quality. This study answers a relevant question about a new treatment for which
clinicians still have questions.
I have only few comments and concerns:
The name of the medical device used is confusing. In the title and the
introduction, the reader may think that bulking agents (solesta, bulkamid etc..)
and implants will be taken into account and compare. This is reinforced by the
paragraph on the bulking agents in the introduction which should be removed
and the aim of the study " this review aims to evaluate whether implantable
bulking agents are superior to injectable bulking agents.."
The term self-expandable prostheses or the trade name Sphinkeeper/Gatekeeper
would be more explicit.
This review was done 1 year ago. Prospective studies have been published since:
an update would be useful.
I find the manuscript too long with repetitions: physiopathology of FI,
implantation technique in introduction; definition of FI in discussion; 
results in
discussion, conclusion etc.. not focused enough on the essential message.
Is it possible to have more informations about unpublished studies ?
In the limitations section, the limitations of the studies are described, not those of
the review. The limitations of the study should be summarized: prospective
studies only taken into account, no comparison of sphinkeeper and gatekeeper,
no consideration of delay to delay defecation etc
Minor remarks:
Page 6, line 18: was conducted 14/01/2021
Reference for PICOS schema ?
Why separate clinical effectiveness FI severity and sustainability of FI severity ?
gathering these informations would be easier to read and avoid repetitions.
Section Disease-related quality of life, line 41 : QOL was assessed by .. already
mentioned in methods.
Section Disease-related quality of life, line 56 106,0; p<0.001) number of
patients ?
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
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
or 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 the 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
interests' below. If your reply is yes to any, please give details below.
No competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please publish my name with my
report.
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
assistant