Perianal injectable bulking agents as treatment for faecal incontinence in adults

Yasuko Maeda; Søren Laurberg; Christine Norton

doi:10.1002/14651858.CD007959.pub3

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Figure 1

PRISMA study flow diagram,

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Figure 2

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

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Figure 3

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

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Analysis 1.1

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

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Analysis 1.2

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

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Analysis 1.3

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

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Analysis 1.4

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

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Analysis 1.5

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

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Analysis 1.6

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

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Analysis 1.7

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

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Analysis 1.8

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

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Analysis 2.1

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

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Analysis 2.2

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

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Analysis 2.3

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

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Analysis 2.4

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

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Analysis 2.5

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

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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).

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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).

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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.

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Analysis 3.4

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

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Analysis 3.5

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

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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
Autologous fat	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
Contigen®	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
Permacol™	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

Table 1. Summary of complications

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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]

Comparison 1. Injectable versus placebo injection

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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]

Comparison 2. One injectable material versus another

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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]

Comparison 3. One method of injection versus another

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