Table 1 Inclusion criteria based on the PICOS (Population, Intervention, Control, Outcomes, Study design) tool [25]: clinical effectiveness and safety for implantable bulking agents for faecal incontinence
Population | Adult patients (≥ 18 yrs) with faecal incontinence (FI) in who conservative treatment interventions failed ICD-10 codes: Faecal incontinence (R15), Other specified diseases of anus and rectum (K62.8) |
Intervention | Bulking agents—self-expandable implantations (= products Gatekeeper™ and Sphinkeeper™) as second-line therapy |
Control | Bulking agents—non-self-expandable injections |
Outcomes | Â |
 Clinical effectiveness | FI severity (Scores: Wexner Cleveland Clinic Faecal Incontinence Score [CCFIS], Vaizey score) Disease-related quality of life (Scores: Faecal Incontinence Quality of Life Scale [FIQL], American Medical Systems score [AMS]) Sustainability of interventions: Durability of effectiveness > 6 months |
 Safety | Procedure-related adverse events Device-related adverse events |
Study design | Randomised controlled trials Prospective non-randomised controlled trials Prospective uncontrolled trials |
Publication period | 2015–2020 |
Languages | English, German |