Table 2 Data extraction table: clinical effectiveness and safety of implantable bulking agents (Gatekeeperâ„¢ and Sphinkeeperâ„¢ [THD s.p.A., Italy]) for faecal incontinence
Product | Gatekeeperâ„¢ | Sphinkeeperâ„¢ | |||||
|---|---|---|---|---|---|---|---|
References | Brusciano [35] | De la Portilla [12] | Ratto [10] | Litta [26] | La Torre [7] | Ratto [17] | |
Country | Italy | Spain | Italy | Italy | Italy | Italy | |
Sponsor | None | NR | NR | None, (1 CoI) | NR | NR (no CoI) | |
Comparator | None | None | None | None | None | None | |
Study design | Prospective, before-after, single-arm, single-centre | Prospective, before-after, single-arm, single-centre | Prospective, before-after, single-arm, multi-centre | Prospective, before-after, single-arm, single-centre | Prospective, before-after, single-arm, single-centre | Prospective, before-after, single-arm, single-centre feasibility study | |
Conducted in | 01/2014–04/2016 | NR | 06/2011–12/2013 | 03/2016–10/2018 | 12/2016–02/2018 | 07/2014–04/2015 | |
Indication | Passive FI | Passive FI | FI not specified (passive, urge, or mixed) | FI not specified (passive, urge, or mixed) | FI not specified (passive, urge, or mixed) | FI Passive (n = 4), urge (n = 4), mixed (n = 3) | |
Intervention | 4 (n = 4) or 6 (n = 16) prostheses | 6 prostheses | 6 prostheses | 10 prostheses | 10 prostheses | 10 prostheses | |
Number of pts at baseline | 20 (20 females) | 7 (6 females) | 54 (37 females)a | 45 pts | 13 (10 females) | 10 (5 females) | |
Number of pts analysed | 20 females | 7 (6 females) | 54 (37 females) | 39 (34 females) | 13 (10 females) | 10 (5 females) | |
Loss to FU, n (%) | 0 (0) | 0 (0) | 0 (0) | 3 (6.7) + 3 (6.7) excluded (unusable data) | 0 (0) | 0 (0) | |
Median age of patients, yrs median (range) | 59 (24–77) | Mean age 55.6 (50.5–57.2) | 66 (41–80) | 68 (58–74) | NR (> 18) | 70 (20–75) | |
Inclusion criteria | FI onset ≥ 6 months Symptoms being refractory to all standard conservative measures | Passive FI for mean duration of 6 ± 2 years IAS lesion extending < 60° of the anal circumference (mean 38 ± 4.0°) | 18–80 years FI onset ≥ 6 months FI episodes > 1x/week Resistant to other conservative treatments Intact anal sphincters or lesion only of IAS maximum circumferential extension of 60° | > 18 yrs FI onset ≥ 6 months FI episodes > 1x/week Failure of conservative treatment IAS and/or EAS defects < 120° Consent to the study Attendance of all FU visits | > 18 yrs FI onset ≥ 6 months FI episodes > 1x/week Resistant to conservative treatments Intact anal sphincters or sphincter injury (IAS, EAS, or both) IAS and EAS defects | 18–80 years FI onset ≥ 6 months FI episodes > 1x/week Willingness to perform FU | |
Exclusion criteria | IAS lesion > 60° and/or EAS lesion > 90° Presence of active perianal sepsis Severe anal scarring Active treatments for anal or rectal cancer IBD with anorectal involvement | NR | IAS lesion > 60° or EAS lesion Previous anal surgery for FI Active perianal sepsis Severe anal scarring IBD with anorectal involvement Anal or rectal cancer Uncontrolled endocrine, metabolic or neurological disease Congenital anorectal malformation | Diagnosis of cancer IBD Acute anorectal sepsis Refractory chronic diarrhoea Rectal bleeding Sphincter defects > 120° | Malignant neoplasms Rectal bleeding Congenital anorectal malformations IBD Sepsis Obstructive defaecation syndrome Neurological disease Coagulation disorders | Malignancies under treatment Rectal bleeding Chronic diarrhoea IBD Acute anorectal sepsis Concomitant rectal prolapse Obstructive defaecation syndrome Neurological disease Coagulation disorder | |
Clinical outcome measures | Clinical effectiveness: FI severity (CCFIS) Safety: NR | Clinical effectiveness: FI severity (CCFIS [= Wexner], diary), QoL (FIQL) Safety: NR | Clinical effectiveness: FI severity (CCFIS, Vaizey, diary), QoL (AMS, FIQL) Safety: NR | Clinical effectiveness: FI severity (CCFIS, Vaizey) Safety: NR | Clinical effectiveness: FI severity (CCFIS, diary), QoL (FIQL) Safety: NR | Clinical effectiveness: FI severity (CCFIS, Vaizey, diary), QoL (AMS, FIQL) Safety: specified parameters | |
FU, months | 1, 3, 6, 12, 24, 36 | 1, 3, 12 | 1, 3, 12 (FU median 12 ± 4) | 1, 3, 6, annually (FU median 14 months [IQR, 7–23]) | 6 | 3 | |
Outcomes | |||||||
Clinical effectiveness | |||||||
Faecal incontinence severity | |||||||
CCFIS (mean ± SD [12, 35], median [range] [10, 17], median [1. and 3. quartile] [26] or mean [range] [7]) | |||||||
|  |  |  | Group A Pts with ≥ 75% improvement in FI (n = 30) | Group B Pts with < 75% improvement in FI (n = 24) |  |  |  |
 Preoperative | 12.4 ± 1.8 | 16.0 ± 4.0 | 12 (3–20) | 12 (9–15) | 12.46 (10–15) | 10 (5–17) | |
|  |  |  | 13 (3–20) | 9 (3–20) |  |  |  |
 Postoperative 3 months | 4.9 ± 1.5; p < 0.0001 | 10.4 ± 3.2; p < 0.01 | 4 (0–19); p < 0.001 | 6 (0–16); p = 0.002 | NR | NA | NR |
 Postoperative 6 months | NR | NA | NA | NR | 8.91 (6–12); p < 0.05 | NA | |
 Postoperative 12 months | NR | 10.1 ± 3.1; p < 0.01 | 5 (0–16); p < 0.001 | NR | NA | NA | |
|  |  |  | 4 (0–22); p < 0.001 | 5 (1–16); p = 0.002b |  |  |  |
 Postoperative 14 months (median) | NA | NA | NA | 7 (5–11); p = 0.001 | NA | NA | |
 Postoperative 24 months | NR | NA | NA | NR | NA | NA | |
 Postoperative 36 months | 4.9 ± 1.7; p < 0.0001 (4.4 ± 1.0; p < 0.0001 with 6 prostheses) | NA | NA | NA | NA | NA | |
Vaizey (mean ± SD [12, 35], median [range] [10, 17], median [1. and 3. quartile] [26] or mean [range] [7]) | |||||||
 Preoperative | NA | NA | 14 (3–24) | 15 (13–18) | NA | 13 (7–16) | |
|  |  |  | 15 (3–24) | 12 (5–21) |  |  |  |
 Postoperative 3 months | NA | NA | 4 (0–19); p < 0.001 | 8.5 (0–18); p = 0.012 | NR | NA | NR |
 Postoperative 6 months | NA | NA | NA | NR | NA | NA | |
 Postoperative 12 months | NA | NA | 6.5 (0–17); p < 0.001 | NR | NA | NA | |
|  |  |  | 4 (0–22); p < 0.001 | 8 (2–17); p = 0.012 |  |  |  |
 Postoperative 14 months | NA | NA | NA | 11 (7–14); p = 0.001 | NA | NA | |
Disease-related QoL | |||||||
FIQL: Lifestyle (mean ± SD [12], median [range] [10, 17] or mean [range] [7]) | |||||||
 Preoperative | NA | NR | NR | NA | 2.62 (2.2–3.1) | 3.2 (2.1–3.8) | |
 Postoperative 3 months | NA | NR; NS | NR | NA | NA | NR | |
 Postoperative 6 months | NA | NA | NA | NA | 3.2 (2.9–3.5); NS | NA | |
 Postoperative 12 months | NA | NR; NS | NR; p = 0.01 | NA | NA | NA | |
FIQL: Coping/behaviour (mean ± SD [12], median [range] [10, 17] or mean [range] [7]) | |||||||
 Preoperative | NA | NR | NR | NA | 1.97 (1.7–2.2) | 2.0 (1.2–2.9) | |
 Postoperative 3 months | NA | NR; NS | NR | NA | NA | NR | |
 Postoperative 6 months | NA | NA | NA | NA | 2.37 (2–2.6); NS | NA | |
 Postoperative 12 months | NA | NR; NS | NR; p = 0.001 | NA | NA | NA | |
FIQL: Depression/self-perception (mean ± SD [12], median [range] [10, 17] or mean [range] [7]) | |||||||
 Preoperative | NA | NR | NR | NA | 2.96 (2.7–3.2) | 3.6 (2.1–3.9) | |
 Postoperative 3 months | NA | NR; NS | NR | NA | NA | NR | |
 Postoperative 6 months | NA | NA | NA | NA | 3.39 (3.1–3.6); NS | NA | |
 Postoperative 12 months | NA | NR; NS | NR; p = 0.029 | NA | NA | NA | |
FIQL: Embarrassment (mean ± SD [12], median [range] [10, 17] or mean [range] [7]) | |||||||
 Preoperative | NA | NR | NR | NA | 2.46 (2–2.8) | 2.3 (2.0–4.0) | |
 Postoperative 3 months | NA | NR; NS | NR | NA | NA | NR | |
 Postoperative 6 months | NA | NA | NA | NA | 3 (2.7–3.4); NS | NA | |
 Postoperative 12 months | NA | NR; NS | NR; p = 0.001 | NA | NA | NA | |
 Preoperative | NA | NA | 87 (27–120) | NA | NA | 80 (26–114) | |
|  |  |  | 94 (28–120) | 82 (27–120) |  |  |  |
 Postoperative 3 months | NA | NA | 32 (0–182); p < 0.001 | 38 (0–80); p < 0.001 | NA | NA | NR |
 Postoperative 6 months | NA | NA | NA | NA | NA | NA | |
 Postoperative 12 months | NA | NA | 43.5 (0–106); p < 0.001c | NA | NA | NA | |
|  |  |  | 32.5 (0–120); p < 0.001 | 59 (1–105); p < 0.001 |  |  |  |
Outcomes | |||||||
Safety (n [%]) | |||||||
Procedure-related adverse events | |||||||
 Intraoperative complications | NR | 0 (0) | 3 (6) prostheses extruded during surgery | 0 (0) | 0 (0) | NR | |
 Postoperative complications/morbidity | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
 Infection/sepsis/inflammation | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
 Anal discomfort/pain, analgesia > 48 h | NR | 1 (14.3) for 4 days | 7 (13) for 4.4 (3.8) days | 2 (5.1) | 0 (0) | 1 (10); for 1 week after surgery | |
 Adverse effect/reaction/general complication | 0 (0) | NR | NR | 0 (0) | NR | 0 (0) | |
Device-related adverse events | |||||||
 Dislodgement of prostheses | 4 (20) | 5 (71.4) 24/42 prostheses in 5/7 pts | 3 (6) | 18 (46.2) | 1 (7.7) | 0 (0) | |
 Prosthesis removed/extruded | NR | 1 (14.3) | NR | NR | 2 (15.4) | 0 (0) | |