Scolaris Content Display Scolaris Content Display

PRISMA study flow diagram,
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Figure 1

PRISMA study flow diagram,

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Injectable versus placebo injection, Outcome 1 Failure (number of participants with Wexner's >8).
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Analysis 1.1

Comparison 1 Injectable versus placebo injection, Outcome 1 Failure (number of participants with Wexner's >8).

Comparison 1 Injectable versus placebo injection, Outcome 2 No improvement (less than 50% reduction in incontinence episodes.
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Analysis 1.2

Comparison 1 Injectable versus placebo injection, Outcome 2 No improvement (less than 50% reduction in incontinence episodes.

Comparison 1 Injectable versus placebo injection, Outcome 3 Number of participants wearing pads every day.
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Analysis 1.3

Comparison 1 Injectable versus placebo injection, Outcome 3 Number of participants wearing pads every day.

Comparison 1 Injectable versus placebo injection, Outcome 4 Number of incontinence free days at 6 months.
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Analysis 1.4

Comparison 1 Injectable versus placebo injection, Outcome 4 Number of incontinence free days at 6 months.

Comparison 1 Injectable versus placebo injection, Outcome 5 Wexner score (mean).
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Analysis 1.5

Comparison 1 Injectable versus placebo injection, Outcome 5 Wexner score (mean).

Comparison 1 Injectable versus placebo injection, Outcome 6 Number of adverse effects.
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Analysis 1.6

Comparison 1 Injectable versus placebo injection, Outcome 6 Number of adverse effects.

Comparison 1 Injectable versus placebo injection, Outcome 7 Serious adverse effects.
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Analysis 1.7

Comparison 1 Injectable versus placebo injection, Outcome 7 Serious adverse effects.

Comparison 1 Injectable versus placebo injection, Outcome 8 Need for re‐treatment at 6 months.
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Analysis 1.8

Comparison 1 Injectable versus placebo injection, Outcome 8 Need for re‐treatment at 6 months.

Comparison 2 One injectable material versus another, Outcome 1 Failure (number with worse faecal incontinence).
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Analysis 2.1

Comparison 2 One injectable material versus another, Outcome 1 Failure (number with worse faecal incontinence).

Comparison 2 One injectable material versus another, Outcome 2 Wexner's incontinence score.
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Analysis 2.2

Comparison 2 One injectable material versus another, Outcome 2 Wexner's incontinence score.

Comparison 2 One injectable material versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.
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Analysis 2.3

Comparison 2 One injectable material versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.

Comparison 2 One injectable material versus another, Outcome 4 Adverse effects.
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Analysis 2.4

Comparison 2 One injectable material versus another, Outcome 4 Adverse effects.

Comparison 2 One injectable material versus another, Outcome 5 Serious adverse effects.
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Analysis 2.5

Comparison 2 One injectable material versus another, Outcome 5 Serious adverse effects.

Comparison 3 One method of injection versus another, Outcome 1 Failure (number of participants with Wexner's score <50% improved).
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Analysis 3.1

Comparison 3 One method of injection versus another, Outcome 1 Failure (number of participants with Wexner's score <50% improved).

Comparison 3 One method of injection versus another, Outcome 2 Failure (number of participants global Quality of Life score <50% improved).
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Analysis 3.2

Comparison 3 One method of injection versus another, Outcome 2 Failure (number of participants global Quality of Life score <50% improved).

Comparison 3 One method of injection versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.
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Analysis 3.3

Comparison 3 One method of injection versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.

Comparison 3 One method of injection versus another, Outcome 4 Discomfort at injection site.
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Analysis 3.4

Comparison 3 One method of injection versus another, Outcome 4 Discomfort at injection site.

Comparison 3 One method of injection versus another, Outcome 5 Adverse effects.
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Analysis 3.5

Comparison 3 One method of injection versus another, Outcome 5 Adverse effects.

Table 1. Summary of complications

Agent

Authors and Year

No of patients

Injection route

Total volume

Complications

Number of adverse effects/Number of participants

Autologous fat

Shafik 1995

14

Submucosal

15‐20ml

Reports that there were no complications

0/14

Bernardi 1998

1

Perianal

130ml

Reports that there were no complications

0/1

Bioplastique™/PTQ™

Malouf 2001

10

Perianal

5‐11.5ml

4 anal canal ulcer, 1 injection site pain, 1 leakage of injected material

6/10

Tjandra 2004

82

Perianal

10.0ml

6 minor discomfort at injection site (4: digital guidance group, 2: ultrasound guidance group)

6/82

Chan 2006

7

Perianal

Not mentioned

Reports that there were no complications

0/7

de la Portilla 2007

20

Perianal

7.5ml

Not reported

Not reported

Maeda 2007

6

Perianal

7.5ml

1 recto‐vaginal fistula

1/6

van der Hagen 2007

24

Perianal

7.5ml

Not reported

Not reported

Gett 2007

37

Not mentioned

Not mentioned

4 perianal abscess required surgical drainage

4/37

Siproudhis 2007

22

Perianal

7.5ml

6 pain at the implant site, 2 anal inflammation

8/22

Soerensen 2009

33

Perianal

7.5ml

Reports that there were no complications

0/33

Tjandra 2009

20

Perianal

10.0ml

4 bruising

4/20

Bartlett 2009

74

Perianal

10.0ml

9 minor complications

9/74

van Wunnik 2012

50

Perianal

Not mentioned

2 local giant cell foreign body reaction

2/50

Bulkamid™

Maeda 2008

5

Perianal

median 9ml (8‐9)

Reports that there were no complications

0/5

Coaptite®

Ganio 2008

10

Perianal

4ml

1 leakage of Coaptite®

1/10

Contigen®

Kumar 1998

17

Submucosal

2ml

Reports that there were no complications

0/17

Stojkovic 2006

73

Submucosal

5ml

Not reported

Not reported

Durasphere®/ACYST‐TM

Weiss 2002

7

Submucosal

average 6.8ml

Not reported

Not reported

Davis 2003

18

Submucosal

mean 1.28ml at 1‐4 sites

2 anal discomfort, 1 exacerbation of pruritis ani, 2 passage of injected Durasphere via anus

5/18

Altomare 2008

33

Submucosal

median 8.8ml (2‐19ml)

2 anal pain, 1 Durasphere® leakage, 2 material migration

5/33

Aigner 2009

11

Perianal

mean 9ml (8‐12ml)

Local pain (most frequent, no numbers reported), 3 passage of Durasphere®

At least 3/11

Tjandra 2009

20

Submucosal

10.0ml

4 bruising, 2 erosion of rectal mucosa, 1 rectal pain, 1 type III hypersensitivity

8/20

Gatekeeper™ (polyacrylonitrile)

Ratto 2011

14

Perianal

1 cylinder (length 21mm, diameter 1‐2mm)x4

Reports that there were none.

0/14

NASHA™Dx

Dehli 2007

4

Submucosal

5.6ml

1 bleeding settled with compression, 1 anal pain, 1 tenesmus. All complications settled within 2‐7 days after procedure.

3/4

Danielson 2009

34

Submucosal

4ml

Pain (26% during 1st injection procedure, 55% for second treatment), 3 suspected inflammation of anal canal, 2 sensation of obstructed defaecation

At least 5/34

Graf 2011

136

Submucosal

4‐8ml

128 adverse events in total. Two serious events, one prostatic abscess and one rectal abscess.

128/136

Dodi 2010

115

Submucosal

up to 4ml

154 adverse events, including 20 serious events such as abscess and haemorrhage

154 adverse events by 70 patients

Permacol™

Smart 2005

7

Submucosal

Not mentioned

Reports that there were no complications

0/7

Maeda 2008

5

Perianal

median 15ml (15‐17.5)

Reports that there were no complications

0/5

Saline

Siproudhis 2007

22

Perianal

7.5ml

2 pain at the implant site

2/22

Synthetic collagen

Ullah 2011

11

Submucosal

Not specified

One death unrelated to the treatment

1/11

Teflon®

Shafik 1993

11

Submucosal

10ml

Not reported

Not reported

Urosurge®

Feretis 2001

6

Submucosal

up to 5 balloons

1 bleeding, 1 lost balloon after 2 months (potential spontaneous burst)

2/6

Bioplastique™/PTQ™: Silicone biomaterial

Bulkamid™: Hydrogel cross‐linked with polyacrylamide

Coaptite®: Calcium hydroxylapatite

Contigen®: Synthetic bovine collagen

Durasphere®/ACYST‐TM: Carbon‐coated microbeads

NASHA™Dx: Stabilized nonanimal hyaluronic acid with dextranomer

Permacol™: Porcine dermal collagen

Teflon®: Polytetrafluoroethylene

Urosurge®: Expandable silicone microballoon

Figures and Tables -
Table 1. Summary of complications
Comparison 1. Injectable versus placebo injection

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure (number of participants with Wexner's >8) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Silicone material (PTQ) versus saline

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 No improvement (less than 50% reduction in incontinence episodes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of participants wearing pads every day Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Silicone material (PTQ) versus saline

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Number of incontinence free days at 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Wexner score (mean) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 Silicone material (PTQ) versus saline

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Number of adverse effects Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 Silicone biomaterial (PTQ) versus saline injection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Serious adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Need for re‐treatment at 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. Injectable versus placebo injection
Comparison 2. One injectable material versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure (number with worse faecal incontinence) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 hydrogel crosslinked with polyacrylamide versus porcine dermal collagen

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at 6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Wexner's incontinence score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at 6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Quality of life index (lifestyle) at 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at 6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere) at 12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Serious adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 2. One injectable material versus another
Comparison 3. One method of injection versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure (number of participants with Wexner's score <50% improved) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Endoanal ultrasound guidance versus digital guidance

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Failure (number of participants global Quality of Life score <50% improved) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Endoanal ultrasound guidance versus digital guidance

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Quality of life index (lifestyle) at 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Endoanal ultrasound guidance versus digital guidance

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Discomfort at injection site Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Endoanal ultrasound guidance versus digital guidance

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 Endoanal ultrasound guidance versus digital guidance

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

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Comparison 3. One method of injection versus another