gms | German Medical Science

23. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin e. V.

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

01. - 03.09.2022, Lübeck

Clinical effectiveness and safety of implantable bulking agents for faecal incontinence: a systematic review

Meeting Abstract

Search Medline for

  • Lucia Gassner - HTA Austria – Austrian Institute for Health Technology Assessment GmbH, Österreich

Evidenzbasierte Medizin für eine bedarfsgerechte Gesundheitsversorgung. 23. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Lübeck, 01.-03.09.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. Doc22ebmPOS-1_2-06

doi: 10.3205/22ebm078, urn:nbn:de:0183-22ebm0786

Published: August 30, 2022

© 2022 Gassner.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background/research question: Faecal incontinence (FI), a common and highly prevalent condition. Patients suffer from complex health problems, causing considerable physical and psychosocial impairments. The purpose of this systematic review is to evaluate whether implantable VS-injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL], sustainability) and safety (adverse events) for faecal incontinence (FI).

Methods: A systematic review was conducted, and five databases were searched. 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 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. FI severity (Cleveland Clinic FI Score) statistically significantly improved to three-months (p<0.01) and six-months (p<0.05) follow-up (five studies). Improvements in severity's sustainability were reported after 12, 14 (p<0.01), and 36 (p<0.0001) months postoperatively. Improved disease-related QoL (FI QoL Score) was found (p<0.05) 12 months after surgery, and statistically significant improvements in QoL's sustainability after 12 months (one study). Procedure-related adverse events (n=3) occurred, where prostheses extruded during surgery, and anal discomfort/pain was felt (n=11). Device-related adverse events, i.e., prostheses’ dislodgement (n=31) and removed/extruded prostheses (n=3), occurred. Studies were judged with moderate/high RoB. The strength of evidence for safety was judged to be very low.

Conclusion: Implantable bulking agents might be an effective/safe minimally invasive option if conservative therapies fail. FI severity significantly improved, but not QoL, which needs to be explored in further studies. Due to the uncontrolled nature of the case series, comparative studies need to be awaited. This review was commissioned by the Austrian Federal Ministry and provides decision support for reimbursement and implantable bulking agents' inclusion in the Austrian hospital benefit catalogue. Therefore, this contribution represents added value for the application of EbM.

Competing interests: None.


References

1.
Ratto C, Buntzen S, Aigner F, Altomare DF, Heydari A, Donisi L, et al. Multicentre observational study of the Gatekeeper for faecal incontinence. Br J Surg. 2016 Feb;103(3):290-9. DOI: 10.1002/bjs.10050 External link
2.
Litta F, Marra AA, Ortega Torrecilla N, Orefice R, Parello A,et al. Implant of Self-Expandable Artificial Anal Sphincter in Patients With Fecal Incontinence Improves External Anal Sphincter Contractility. Dis Colon Rectum. 2021 Jun 1;64(6):706-13. DOI: 10.1097/DCR.0000000000001857 External link
3.
Brusciano L, Tolone S, Del Genio G, Grossi U, Schiattarella A, Piccolo FP, et al. Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence. Dis Colon Rectum. 2020 Apr;63(4):514-519. DOI: 10.1097/DCR.0000000000001559 External link