Perianal injectable bulking agents as treatment for faecal incontinence in adults

Yasuko Maeda; Søren Laurberg; Christine Norton

doi:10.1002/14651858.CD007959.pub3

Agentes aumentadores de volumen inyectables perianales como tratamiento para la incontinencia fecal en adultos

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References

References to studies included in this review

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excluded studies
ongoing studies
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References to studies excluded from this review

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included studies
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References to ongoing studies

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included studies
excluded studies
additional references
other published versions

Dehli T, Vonen B, Stordahl A, Jacobsen A, Lindsetmo RO, Mevik K. A randomized, controlled, clinical trial of biofeedback and anal injections as first treatment of fecal incontinence. ControlledTrials.com (www.controlled‐trials.com) [accessed 18 July 2009]2009.

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Draganic B. PTQ versus Durasphere in the treatment of faecal incontinence ‐ a prospective study comparing two injectable bulking agents (http://www.anzctr.org.au/ACTRN12610000651088.aspx). Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au/2008.

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EUCTR2010‐021463‐32‐AT. Skeletal muscle‐derived cell implantation for the treatment of fecal incontinence: a multicenter, randomized, double‐blind, placebocontrolled, parallel‐group, dose‐finding clinical study (available at: http://apps.who.int/trialsearch/Trial.aspx?TrialID=EUCTR2010‐021463‐32‐AT). EU Clinical Trials Register2011.

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Michot F. Myoblast for Anal Incontinence (MIAS) (http://clinicaltrials.gov/show/NCT01523522). ClinicalTrials.gov2012.

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NCT00762047. A prospective, multi‐center, randomized, blinded study to evaluate Durasphere FI for the treatment of fecal incontinence. ClinicalTrials.gov2009.

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Norderval S, Rydningen M. A blinded randomized controlled clinical trial comparing sacral nerve modulation and anal bulking injections as treatment for fecal incontinence after obstetric anal sphincter injuries (OASIS) (http://clinicaltrials.gov/show/NCT01528995). ClinicalTrials.gov2012.

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Additional references

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ongoing studies
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References to other published versions of this review

Jump to:

included studies
excluded studies
ongoing studies
additional references

Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2010, Issue 5. [DOI: 10.1002/14651858.CD007959.pub2; PUBMED: 20464759]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies
ongoing studies

Graf 2011

Methods	Randomised, double‐blind, sham‐controlled trial Muticentre, USA and Europe
Participants	206 patients with Cleveland Clinic Florida Faecal Incontinence (CCFIS) of 10 or more and at least four recorded incontinence episodes in 2 weeks, had symptoms for at least 12 months NASHA Dx group: median 61.8 years (interquartile range 55.5‐68.3), sham group: median 60.1 years (interquartile range 51.3‐66.7)
Interventions	Intervention: Injection of 4‐8mls dextranomer in stabilised hyaluronic acid (NASHA Dx) Control: Sham injection (the procedure mimicked active treatment without injection of any substance)
Outcomes	Primary endpoint: A reduction in number of incontinence episodes by 50% or more compared with baseline. Number of patients achieving this endpoint: NASHA Dx group 71 patients (52%), sham group 22 patients (31%). Secondary endpoints: Change from baseline in number of incontinence free days. Number of faecal incontinence episodes, and CCFIS at 3 months and 6 months. Adverse events. Mean increase in incontinence free days at 6 months: NASHA Dx 3.1 days, sham group 1.7 days (p=0.0156). Decrease in number of faecal incontinence episodes at 3 months: NASHA Dx 4.8, sham 3.0 p=0.14, and at 6 months: NASHA Dx 6.0, sham 3.0, p=0.09. Change in CCFIS at 3 months: NASHA Dx 2.6, sham 2.0, and at 6 months: NASHA Dx 2.5, sham 1.7, both differences stated as not statistically significant but no p values provided. Adverse events: NASGHA Dx 128 events, sham group 29 events Number of people requiring retreatment: Intervention 112/136, control 61/70
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation stratified by sex and region (USA versus Europe) in block of six, and managed with an automated, real‐time, central web‐based system
Allocation concealment (selection bias)	Unclear risk	No data
Blinding (performance bias and detection bias) Participants	Low risk	Patients were masked to treatment during the first 6 months
Blinding (performance bias and detection bias) Surgeons	High risk	Not possible
Blinding (performance bias and detection bias) Outcome assessors	Low risk	Masked to treatment during the first 6 months
Incomplete outcome data (attrition bias) All outcomes	High risk	16 participants dropped out. Sham group were followed up only up to 6 months

Maeda 2008

Methods	Randomised single‐blinded treatment Single centre, UK
Participants	10 patients, 9 female, median age 68 years, range 45 to 79 Inclusion: Passive faecal incontinence to solid or liquid stool secondary to internal anal sphincter dysfunction; failure of antidiarrhoeal drugs and biofeedback
Interventions	A (n=5): Bulkamid™ (hydrogel cross‐linked with polyacrylamide) mean volume 9ml B (n=5): Permacol™ (porcine dermal collagen) mean volume 15ml General anaesthetic, prophylactic antibiotics (cephalosporin and metronidazole), injection into the intersphincteric space under digital guidance
Outcomes	St Mark's incontinence score, faecal incontinence quality of life scale, Short Form‐36 health survey, 1‐week bowel diary card Outcomes at 19 months: A 4/5 improved, 1/5 worse; B 1/4 improved, 2/4 same, 1/4 worse St Mark's Continence score at 6 months (median [range]): A 12 [6 to 18], B 15 [8 to 22] Faecal incontinence QoL score increased in both groups during 6 months follow up, no difference between groups
Notes	Pilot study
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation schedule predetermined before recruitment to ensure equal distribution
Allocation concealment (selection bias)	Unclear risk	Prospectively randomised
Blinding (performance bias and detection bias) Participants	Unclear risk	No data
Blinding (performance bias and detection bias) Surgeons	High risk	Not possible
Blinding (performance bias and detection bias) Outcome assessors	Unclear risk	No data
Incomplete outcome data (attrition bias) All outcomes	Low risk	No drop‐outs

Siproudhis 2007

Methods	Randomised double‐blind trial (participants and outcome observers blinded) Single centre, France
Participants	44 female patients (mean age 64.3 years, standard deviation 9) with passive incontinence and Wexner's incontinence score of 9 or more (classed as severe faecal incontinence) Groups comparable at baseline
Interventions	A (n=22): Injection of polydimethylsiloxane elastomer implants (7.5ml) B (n=22): Saline (control) Local anaesthetic, prophylactic lactulose and antibiotic (metronidazole), injection perianally into the inter‐sphincteric space
Outcomes	Success defined as a Wexner's score 8 or less at 3 months after injection Failure (Wexner's score >8): A 17/22, B 16/22 Need to wear pads every day: A 17/22, B 15/22 Wexner's score at 3 months (mean (SD) N): A 11.7 (4.7) 22, B 11.4 (4.5) 22 P=0.79 Adverse effects related to intervention (n/N of participants): A 7/22, B 2/22
Notes	Outcome table seems to provide data for 24 participants in each group (but only 22 randomised)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not mentioned
Allocation concealment (selection bias)	Unclear risk	Randomisation method not mentioned
Blinding (performance bias and detection bias) Participants	Low risk	Yes
Blinding (performance bias and detection bias) Surgeons	High risk	Not possible
Blinding (performance bias and detection bias) Outcome assessors	Low risk	Doctor and nurse blinded to allocation and intervention
Incomplete outcome data (attrition bias) All outcomes	Low risk	No drop‐outs

Tjandra 2004

Methods	Randomised single‐blind trial of different injection technique Single centre, Australia
Participants	82 patients, 64 females, median 66 years, range 34 to 89 Inclusion: severe faecal incontinence, low anal resting pressure, internal anal sphincter dysfunction Exclusion: pregnancy, active perianal sepsis, unresected anorectal cancer, immunosuppression Groups comparable at baseline on age, gender, past anorectal surgery, duration of follow up (median 6 months, range 1 to 12), baseline continence score Follow up at 1, 3, 6, 9 and 12 months Drop‐outs: at 3 months A 4, B 8; at 6 months A 12, B 19; at 12 months A 32, B 35
Interventions	A (42): Injection under endoanal ultrasound guidance B (40): Injection under digital guidance Local anaesthetic, prophylactic antibiotics (cephalosporin and metronidazole) Both groups had 10ml silicone biomaterial injected into the intersphincteric space
Outcomes	Wexner's continence score, global quality of life on visual analogue scale, faecal incontinence quality of life scale Number achieving >50% improvement in Wexner's continence score at 3 months: A 26/38, B 13/32 (failure: A 12/38, B 19/32) Wexner's score at 6 months (median (range) N: A: 5 (2 to 13) B 8 (2 to 12) Wexner's score at 12 months: A 3 (1 to 12), B 11 (2 to 12) Number achieving >50% improvement in global QoL score at 3 months: A 35/38, B 29/32 (not improved: A 3/38, B 3/32) Faecal Incontinence Quality of Life index lifestyle at 6 months (mean (SD) N): A 3.7 (0.44) 42, B 3.1 (0.83) 31 Adverse effects: A 0/42, B 0/40 Discomfort at injection site: A 2/42, B 4/40
Notes	Data provided as medians and ranges, precluding meta‐analysis Wexner's score: higher = worse outcome Visual analogue score, FI QoL score: higher = better outcome
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No data
Allocation concealment (selection bias)	Unclear risk	"Randomized"
Blinding (performance bias and detection bias) Participants	Unclear risk	No data
Blinding (performance bias and detection bias) Surgeons	High risk	Not possible
Blinding (performance bias and detection bias) Outcome assessors	Unclear risk	No data
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Adjustment for multiple comparisons but high drop‐out rate

Tjandra 2009

Methods	Randomised single‐blinded study Single centre, Australia
Participants	40 patients (36 male, 4 female) Inclusion: faecal seepage or soiling for more than twice a week caused by internal sphincter dysfunction, low or borderline resting anal canal pressure, failed 6 months' treatment with pelvic floor exercise and stool bulking agents Exclusion: perianal sepsis, anorectal cancer, immunosuppression, rectal prolapse, inflammatory bowel disease, congenital anorectal malformation, neurological disorders (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury), stoma in situ, pregnancy, external anal sphincter defect >120^oof circumference, bleeding diathesis, mental or physical disability precluding adherence to protocol Use of antidiarrhoeal medications not allowed during study period. Baseline Wexner's score 11.5 Groups comparable at baseline on Wexner's score, age, past obstetric history, previous anorectal surgery, FIQL and SF‐12
Interventions	A (20): Intersphincteric injection with silicone biomaterial (PTQ) 10ml B (20): Submucosal injection with carbon‐coated beads (Durasphere) 10ml Enema, local anaesthetic, prophylactic antibiotics (cephalosporin and metronidazole), day case procedure
Outcomes	Wexner's incontinence score, faecal incontinence quality of life scale, Short Form 12 health survey questionnaire Adverse effects: A bruising 4/20, B bruising 4/20, rectal pain 1/20, erosion through rectal mucosa 2/20, type III hypersensitivity reaction 1/20 (requiring hospital care for 7 days, intravenous steroids, 10 week recovery period) Number with >50% improvement in Wexner's score at 6 months: A 19/20, B 8/20 (not improved: A 1/20, B 12/20) Number with >50% improvement in Wexner's score at 12 months: A 18/20, B 7/20 (not improved: A 2/20, B 13/20) Wexner score at 6 months (mean (SD) N): 2.95 (1.7) 20, B 6.2 (2.69) 20 Wexner score at 12 months (mean (SD) N): 3.8 (2.76) 20, B 7 (2.77) 20 Faecal Incontinence Quality of Life index lifestyle at 6 months (mean (SD) N): A 3.68 (0.41) 20, B 3.12 (0.93) 20 Faecal Incontinence Quality of Life index lifestyle at 6 months (mean (SD) N): A 3.43 (0.33) 20, B 3.10 (0.86) 20
Notes	Power calculation provided
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central registry
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding (performance bias and detection bias) Participants	Low risk	Treatment allocation blinded
Blinding (performance bias and detection bias) Surgeons	High risk	Not possible (different injection site)
Blinding (performance bias and detection bias) Outcome assessors	Unclear risk	No data
Incomplete outcome data (attrition bias) All outcomes	Low risk	No drop‐outs

Characteristics of excluded studies [ordered by study ID]

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included studies
ongoing studies

Study	Reason for exclusion
Dehli 2007	A case‐series study

Characteristics of ongoing studies [ordered by study ID]

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included studies
excluded studies

Dehli 2009

Trial name or title	A randomized, controlled, clinical trial of biofeedback and anal injections as first treatment of fecal incontinence
Methods	Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study
Participants
Interventions	Procedure: Anal injection Procedure: Biofeedback
Outcomes	Incontinence measured by St.Marks incontinence score
Starting date	May 2006
Contact information
Notes

Draganic 2008

Trial name or title	PTQ versus Durasphere in the treatment of faecal incontinence – a prospective study comparing two injectable bulking agents
Methods	Randomised controlled trial
Participants	Patients with faecal incontinence who, after discussion with a specialist, have opted to undergo treatment with an injectable bulking agent.
Interventions	Intervention: PTQ Intervention: Durasphere
Outcomes	Primary: Wexner incontinence score, SF‐36 quality of life score at 6 weeks post‐procedure
Starting date	1/05/2008
Contact information	Dr Owen J Morris
Notes	According to personal communication, the study is completed and the investigators are preparing for publication

EUCTR2010‐021463‐32‐AT 2011

Trial name or title	Skeletal muscle‐derived cell implantation for the treatment of fecal incontinence
Methods	Multicentre, randomised, double‐blind, placebo controlled, parallel‐group, dose‐finding clinical study
Participants
Interventions	Skeletal muscle‐derived cells suspension for injection Intervention: Concentration number 20000000‐40000000 Intervention: Concentration number 70000000‐110000000
Outcomes	Frequency of incontinence episodes
Starting date	24/02/2011
Contact information	Patientenanwaltschaft
Notes	This is a study for external sphincter injury

Michot 2012

Trial name or title	Myoblast for Anal Incontinence (MIAS)
Methods	Randomised, double‐blind
Participants
Interventions	Intervention: Myoblast injection Intervention: saline solution injection
Outcomes	Improvement of anal incontinence score, improvement of quality of life score
Starting date	January 2012
Contact information	Rouen University Hospital, Rouen, France, 76000
Notes	This is a study for external sphincter injury

NCT00762047 2009

Trial name or title	A prospective, multi‐center, randomized, blinded study to evaluate durasphere FI for the treatment of fecal incontinence
Methods	Randomised, double‐blind
Participants	Faecal incontinence in adult men and women. Planned to enroll 90 participants.
Interventions	Intervention: Durasphere FI Intervention: Sham
Outcomes	The frequency and severity of fecal incontinence symptoms Analysis of morbidity and complication rates associated with Durasphere. The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Starting date	June 2004
Contact information	http://clinicaltrials.gov/ct2/show/NCT00762047
Notes	The study appears to have been terminated in 2009, reason not stated ‐ writing to trialists to find out more.

Norderval 2012

Trial name or title	Treatment of Fecal Incontinence After Obstetric Anal Sphincter Injuries (KISS)
Methods	Randomised, single‐blinded (outcome assessor), efficacy study
Participants
Interventions	Intervention: sacral nerve stimulation Intervention: Permacol injection
Outcomes	Change in St Marks incontinence score
Starting date	February 2012
Contact information	Mona B Rydningen
Notes	This is a study for external sphincter injury

Smart 2008

Trial name or title	A randomised controlled trial comparing the route of injection using Permacol (collagen)
Methods	Randomised
Participants	Participants with (passive) faecal incontinence
Interventions	Permacol (collagen). Comparing one route of injection with another
Outcomes
Starting date	'Currently in progress' at February 2008
Contact information	The two authors of the letter were based in Plymouth and Gateshead at the time of publication of their letter in 2008.
Notes

Data and analyses

Open in table viewer

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
Open in figure viewer Analysis 1.1 Comparison 1 Injectable versus placebo injection, Outcome 1 Failure (number of participants with Wexner's >8).
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
Open in figure viewer Analysis 1.2 Comparison 1 Injectable versus placebo injection, Outcome 2 No improvement (less than 50% reduction in incontinence episodes.
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
Open in figure viewer Analysis 1.3 Comparison 1 Injectable versus placebo injection, Outcome 3 Number of participants wearing pads every day.
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
Open in figure viewer Analysis 1.4 Comparison 1 Injectable versus placebo injection, Outcome 4 Number of incontinence free days at 6 months.
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
Open in figure viewer Analysis 1.5 Comparison 1 Injectable versus placebo injection, Outcome 5 Wexner score (mean).
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
Open in figure viewer Analysis 1.6 Comparison 1 Injectable versus placebo injection, Outcome 6 Number of adverse effects.
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
Open in figure viewer Analysis 1.7 Comparison 1 Injectable versus placebo injection, Outcome 7 Serious adverse effects.
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
Open in figure viewer Analysis 1.8 Comparison 1 Injectable versus placebo injection, Outcome 8 Need for re‐treatment at 6 months.
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]

Open in table viewer

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
Open in figure viewer Analysis 2.1 Comparison 2 One injectable material versus another, Outcome 1 Failure (number with worse faecal incontinence).
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
Open in figure viewer Analysis 2.2 Comparison 2 One injectable material versus another, Outcome 2 Wexner's incontinence score.
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
Open in figure viewer Analysis 2.3 Comparison 2 One injectable material versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.
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
Open in figure viewer Analysis 2.4 Comparison 2 One injectable material versus another, Outcome 4 Adverse effects.
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
Open in figure viewer Analysis 2.5 Comparison 2 One injectable material versus another, Outcome 5 Serious adverse effects.
5.1 silicone biomaterial (PTQ) versus carbon‐coated spheres (Durasphere)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Open in table viewer

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
Open in figure viewer Analysis 3.1 Comparison 3 One method of injection versus another, Outcome 1 Failure (number of participants with Wexner's score <50% improved).
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
Open in figure viewer Analysis 3.2 Comparison 3 One method of injection versus another, Outcome 2 Failure (number of participants global Quality of Life score <50% improved).
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
Open in figure viewer Analysis 3.3 Comparison 3 One method of injection versus another, Outcome 3 Quality of life index (lifestyle) at 6 months.
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
Open in figure viewer Analysis 3.4 Comparison 3 One method of injection versus another, Outcome 4 Discomfort at injection site.
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
Open in figure viewer Analysis 3.5 Comparison 3 One method of injection versus another, Outcome 5 Adverse effects.
5.1 Endoanal ultrasound guidance versus digital guidance	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

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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References

References to studies included in this review

Graf 2011 {published data only}

Maeda 2008 {published data only}

Siproudhis 2007 {published data only}

Tjandra 2004 {published data only}

Tjandra 2009 {published data only}

References to studies excluded from this review

Dehli 2007 {published data only}

References to ongoing studies

Dehli 2009 {published data only}

Draganic 2008 {published data only}

EUCTR2010‐021463‐32‐AT 2011 {published data only}

Michot 2012 {published data only}

NCT00762047 2009 {published data only}

Norderval 2012 {published data only}

Smart 2008 {published data only}

Additional references

Aigner 2009

Altomare 2008

Bartlett 2009

Bernardi 1998

Bharucha 2010

Brown 2010

Chan 2006

Cheetham 2003

Christiansen 1999

Da Silva 2003

Danielson 2009

Davis 2003

de la Portilla 2007

Deutekom 2012

Dodi 2010

Engel 1995

Fader 2008

Felt‐Bersma 1996

Feretis 2001

Frudinger 2010

Ganio 2008

Gett 2007

Higgins 2011

Hosker 2007

Hussain 2011

Kumar 1998

Leroi 1997

Lindsey 2004

Luo 2010

Maeda 2007

Malouf 2001

Morgan 1997

Mowatt 2007

NICE 2007

Norton 2012

Rao 2004

Ratto 2011

Shafik 1993

Shafik 1995

Smart 2005

Soerensen 2009

Stojkovic 2006

Ullah 2011

Vaizey 1997

van der Hagen 2007

van Wunnik 2012

Weiss 2002

Wexner 1996

Wheeler 2007

Whitehead 2009

References to other published versions of this review

Maeda 2010

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Data and analyses

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