OP18 Clinical Effectiveness And Safety Of Implantable Bulking Agents For Fecal Incontinence: A Systematic Review

OP18 Clinical Effectiveness And Safety Of Implantable Bulking Agents For Fecal Incontinence: A Systematic Review

Introduction The purpose of this systematic review is to evaluate whether implantable versus injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL], sustainability) and safety (adverse events) for fecal incontinence (FI). Metho...

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Published in:International journal of technology assessment in health care 2022-12, Vol.38 (S1), p.S8-S8
Main Authors: Gassner, Lucia, Wild, Claudia, Walter, Melanie
Format: Article
Language:eng
Subjects:
Adverse events
Clinical trials
Comparative studies
Criteria
Effectiveness
Evaluation
Extrusion
Fecal incontinence
Health risks
Oral Presentations
Pain
Prostheses
Prosthetics
Qualitative analysis
Quality
Quality of life
Safety
Statistical analysis
Surgery
Sustainability
Systematic review
Technology assessment
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Summary:Introduction The purpose of this systematic review is to evaluate whether implantable versus injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL], sustainability) and safety (adverse events) for fecal incontinence (FI). Methods A systematic review was conducted and five databases were searched (Medline via Ovid, Embase, Cochrane Library, University of York Centre for Reviews and Dissemination, and International Network of Agencies for Health Technology Assessment database). In-/exclusion criteria were predefined according to the PICOS scheme. The Institute of Health Economics risk of bias (RoB) tool assessed studies’ internal validity. According to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the strength of evidence for safety outcomes was rated. A qualitative synthesis of the evidence was used to analyse the data. Results Six prospective uncontrolled trials (143 patients) were included. The evidence consists of six prospective single-arm, before-after studies fulfilling the inclusion criteria for assessing clinical effectiveness and safety for implantable bulking agents. FI severity (Cleveland Clinic FI Score) statistically significantly improved to three months (p
ISSN:0266-4623
1471-6348