Table 1.
Summary of studies selected for review.
| Study | Insert type | N | Population | Study design | Duration | Treatment outcomes | QoL | Discontinuation rate | AEs | Strengths | Weaknesses |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Richter et al., 2015 [14] | Eclipse vaginal insert | 110 (ITT: 61 PP: 56 3-months: 44) |
Adult women with ≥2 FI episodes/week | Prospective effectiveness and safety trial | 1 month, 3 months |
1 month: 48/61 subjects had >50% FI reduction 39/56 subjects had >75% FI reduction 23/46 subjects had 100% continence 3 months: 38/44 subjects had >50% FI reduction 32/44 subjects had >75% FI reduction 20/44 subjects had 100% continence |
-Increased FIQOL -Decreased MMHQ -50/56 were satisfied -54/55 would recommend to a friend |
49 subjects (44.5%) did not achieve a successful fit | No serious AEs 18 device-related AEs (primarily pelvic discomfort or vaginal findings on examination) |
Multiple validated outcome measures | Small sample, short study duration, lack of placebo group |
| Varma et al., 2016 [15] | Eclipse vaginal insert | 56 | Adult women with ≥2 FI episodes/week | Secondary analysis | 1 month | 15% reduction in liquid bowel movements 28% reduction in faecal urgency 13% reduction in incomplete evacuation |
N/A | N/A | N/A | Descriptive analysis | |
| Mortensen and Humphreys, 1991 [16] | Conseal anal insert (3 designs) | 10 | Adults (8 female, 2 male) | Cross-over pilot trial | 3 weeks (each anal insert design for 1 week) | Incontinent defecations: Design #1–18% Design #2–19% Design #3–15% Median duration of use/day: Design #1–12 h Design #2–11 h Design #3–7 h |
Easy insertion: Design #1–79% Design #2–82% Design #3–52% Preferred Design: #1–5/9 subjects #2–3/9 subjects #3–1/9 subjects |
1 subject (10%) | No serious AEs reported -Persistent discomfort in 2/9 subjects |
Cross-over design | Small sample, short study duration |
| Christiansen and Roed-Petersen, 1993 [17] | Conseal anal insert (Design #1 from prior study) | 14 | Adults (9 female, 5 male) | Prospective pilot trial | 4 weeks | 9/14 subjects were continent with the device in place | All 14 subjects reported they felt ‘safe’ and ‘mentally better’ with the device in place | 11 subjects dropped out due to discomfort 1 subject (6%) did not follow up for treatment |
No serious AEs reported | Small sample, minority of subjects completed the study protocol | |
| Norton and Kamm, 2001 [18] | Conseal anal insert (37 and 45 mm) | 20 | Adults (16 female, 4 male) | Cross-over pilot trial | 4 weeks (each insert for 2 weeks) | 10/20 subjects were continent with the device in place No difference in comfort between subjects with intact vs impaired rectal sensory function |
4 subjects (20%) reported they would use the insert continuously No difference in comfort between the 2 inserts |
9 subjects (45%) dropped out after the first insert due to discomfort | No serious AEs reported | Cross-over design | Small sample, minority of subjects completed the study protocol |
| Pfrommer et al., 2000 [19] | Conseal anal insert vs EFF-EFF anal insert |
38 | Children with prior repair of anorectal malformation | Randomised cross-over trial | 6 weeks (each insert for 3 weeks) | 12/23 subjects endorsed 100% continence with both inserts 61% of patients preferred the Conseal insert vs 22% who preferred the EFF-EFF insert |
Preferred insert: Conseal – 14/23 EFF-EFF – 5/23 No preference – 4/23 |
15 subjects (39%) dropped out due to discomfort | No serious AEs reported | Cross-over design | Small sample, paediatric patient population with prior congenital malformation |
| Giamundo et al., 2002 [20] | Procon anal insert | 18 consented, 7 completed the study protocol |
Adults (5 female, 2 male) | Prospective pilot trial | 2 weeks | Decreased Cleveland Clinic Florida Incontinence Score (mean 7.5 points) | 5 subjects (28%) reported complete satisfaction | 11 subjects (61%) dropped out due to hypersensitivity or difficulty operating the device | No serious AEs reported | Validated outcome measure | Small sample, minority of subjects completed the study protocol |
| Lukacz et al., 2015 [21] | Renew anal insert (ITT: 91 mITT: 85 PP: 73) |
97 | Adults with ≥ 1 FI episode/week (82 female, 9 male) |
Prospective single-arm study | 12 weeks | 1 month: 66/85 subjects had >50% FI reduction 3 months: 56/73 subjects had >50% FI reduction FI frequency reduced from 0.9 to 0.2 FI episodes/day 26% reduction in FI frequency from baseline after subjects discontinued treatment for 4 weeks |
78% of subjects who completed treatment were very or extremely satisfied | 12 subjects dropped out if they did not meet eligibility, found the protocol too demanding, or repeatedly lost the insert (12%) | No serious AEs reported 3 moderate AEs (faecal urgency, haemorrhoid bleeding) |
Return to baseline evaluation, daily bowel diaries | Short study duration, lack of validated questionnaires |
AE, adverse event; FIQOL, Fecal Incontinence Quality of Life; MMHQ, Modified Manchester Health Questionnaire; PP, per protocol, QoL, quality of life.