Review for 10.1186/s12876-022-02441-4 (2022)

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Is it possible to have more informations about unpublished studies ?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 ?
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Is the study design appropriate to answer the research question (including the use
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presented?
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