Intervention Review

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Perianal injectable bulking agents as treatment for faecal incontinence in adults

  1. Yasuko Maeda1,*,
  2. Søren Laurberg2,
  3. Christine Norton3

Editorial Group: Cochrane Incontinence Group

Published Online: 28 FEB 2013

Assessed as up-to-date: 25 MAY 2012

DOI: 10.1002/14651858.CD007959.pub3

How to Cite

Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD007959. DOI: 10.1002/14651858.CD007959.pub3.

Author Information

  1. 1

    St Mark's Hospital, Sir Alan Park's Physiology Unit, Harrow, UK

  2. 2

    Aarhus University Hospital, Department of Surgery, Aarhus, Denmark

  3. 3

    King's College London & Imperial College Healthcare NHS Trust, London, UK

*Yasuko Maeda, Sir Alan Park's Physiology Unit, St Mark's Hospital, Northwick Park, Watford Road, Harrow, UK. yazmaeda@gmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by study ID]
Graf 2011

MethodsRandomised, double-blind, sham-controlled trial

Muticentre, USA and Europe


Participants206 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)


InterventionsIntervention: Injection of 4-8mls dextranomer in stabilised hyaluronic acid (NASHA Dx)

Control: Sham injection (the procedure mimicked active treatment without injection of any substance)


OutcomesPrimary 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

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation 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 riskNo data

Blinding (performance bias and detection bias)
Participants
Low riskPatients were masked to treatment during the first 6 months

Blinding (performance bias and detection bias)
Surgeons
High riskNot possible

Blinding (performance bias and detection bias)
Outcome assessors
Low riskMasked to treatment during the first 6 months

Incomplete outcome data (attrition bias)
All outcomes
High risk16 participants dropped out. Sham group were followed up only up to 6 months

Maeda 2008

MethodsRandomised single-blinded treatment

Single centre, UK


Participants10 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


InterventionsA (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


OutcomesSt 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


NotesPilot study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation schedule predetermined before recruitment to ensure equal distribution

Allocation concealment (selection bias)Unclear riskProspectively randomised

Blinding (performance bias and detection bias)
Participants
Unclear riskNo data

Blinding (performance bias and detection bias)
Surgeons
High riskNot possible

Blinding (performance bias and detection bias)
Outcome assessors
Unclear riskNo data

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs

Siproudhis 2007

MethodsRandomised double-blind trial (participants and outcome observers blinded)

Single centre, France


Participants44 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


InterventionsA (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


OutcomesSuccess 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


NotesOutcome table seems to provide data for 24 participants in each group (but only 22 randomised)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot mentioned

Allocation concealment (selection bias)Unclear riskRandomisation method not mentioned

Blinding (performance bias and detection bias)
Participants
Low riskYes

Blinding (performance bias and detection bias)
Surgeons
High riskNot possible

Blinding (performance bias and detection bias)
Outcome assessors
Low riskDoctor and nurse blinded to allocation and intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs

Tjandra 2004

MethodsRandomised single-blind trial of different injection technique

Single centre, Australia


Participants82 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


InterventionsA (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


OutcomesWexner'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


NotesData 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

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo data

Allocation concealment (selection bias)Unclear risk"Randomized"

Blinding (performance bias and detection bias)
Participants
Unclear riskNo data

Blinding (performance bias and detection bias)
Surgeons
High riskNot possible

Blinding (performance bias and detection bias)
Outcome assessors
Unclear riskNo data

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAdjustment for multiple comparisons but high drop-out rate

Tjandra 2009

MethodsRandomised single-blinded study

Single centre, Australia


Participants40 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 >120oof 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


InterventionsA (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


OutcomesWexner'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


NotesPower calculation provided


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentral registry

Allocation concealment (selection bias)Low riskSealed envelopes

Blinding (performance bias and detection bias)
Participants
Low riskTreatment allocation blinded

Blinding (performance bias and detection bias)
Surgeons
High riskNot possible (different injection site)

Blinding (performance bias and detection bias)
Outcome assessors
Unclear riskNo data

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Dehli 2007A case-series study

 
Characteristics of ongoing studies [ordered by study ID]
Dehli 2009

Trial name or titleA randomized, controlled, clinical trial of biofeedback and anal injections as first treatment of fecal incontinence

MethodsTreatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study

Participants

InterventionsProcedure: Anal injection
Procedure: Biofeedback

OutcomesIncontinence measured by St.Marks incontinence score

Starting dateMay 2006

Contact information

Notes

Draganic 2008

Trial name or titlePTQ versus Durasphere in the treatment of faecal incontinence – a prospective study comparing two injectable bulking agents

MethodsRandomised controlled trial

ParticipantsPatients with faecal incontinence who, after discussion with a specialist, have opted to undergo treatment with an injectable bulking agent.

InterventionsIntervention: PTQ

Intervention: Durasphere

OutcomesPrimary: Wexner incontinence score, SF-36 quality of life score at 6 weeks post-procedure

Starting date1/05/2008

Contact informationDr Owen J Morris

NotesAccording to personal communication, the study is completed and the investigators are preparing for publication

EUCTR2010-021463-32-AT 2011

Trial name or titleSkeletal muscle-derived cell implantation for the treatment of fecal incontinence

MethodsMulticentre, randomised, double-blind, placebo controlled, parallel-group, dose-finding clinical study

Participants

InterventionsSkeletal muscle-derived cells suspension for injection

Intervention: Concentration number 20000000-40000000

Intervention: Concentration number 70000000-110000000

OutcomesFrequency of incontinence episodes

Starting date24/02/2011

Contact informationPatientenanwaltschaft

NotesThis is a study for external sphincter injury

Michot 2012

Trial name or titleMyoblast for Anal Incontinence (MIAS)

MethodsRandomised, double-blind

Participants

InterventionsIntervention: Myoblast injection
Intervention: saline solution injection

OutcomesImprovement of anal incontinence score, improvement of quality of life score

Starting dateJanuary 2012

Contact informationRouen University Hospital, Rouen, France, 76000

NotesThis is a study for external sphincter injury

NCT00762047 2009

Trial name or titleA prospective, multi-center, randomized, blinded study to evaluate durasphere FI for the treatment of fecal incontinence

MethodsRandomised, double-blind

ParticipantsFaecal incontinence in adult men and women. Planned to enroll 90 participants.

InterventionsIntervention: 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 dateJune 2004

Contact informationhttp://clinicaltrials.gov/ct2/show/NCT00762047

NotesThe study appears to have been terminated in 2009, reason not stated - writing to trialists to find out more.

Norderval 2012

Trial name or titleTreatment of Fecal Incontinence After Obstetric Anal Sphincter Injuries (KISS)

MethodsRandomised, single-blinded (outcome assessor), efficacy study

Participants

InterventionsIntervention: sacral nerve stimulation

Intervention: Permacol injection

OutcomesChange in St Marks incontinence score

Starting dateFebruary 2012

Contact informationMona B Rydningen

NotesThis is a study for external sphincter injury

Smart 2008

Trial name or titleA randomised controlled trial comparing the route of injection using Permacol (collagen)

MethodsRandomised

ParticipantsParticipants with (passive) faecal incontinence

InterventionsPermacol (collagen). Comparing one route of injection with another

Outcomes

Starting date'Currently in progress' at February 2008

Contact informationThe two authors of the letter were based in Plymouth and Gateshead at the time of publication of their letter in 2008.

Notes

 
Comparison 1. Injectable versus placebo injection

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Failure (number of participants with Wexner's >8)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Silicone material (PTQ) versus saline
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 No improvement (less than 50% reduction in incontinence episodes1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Number of participants wearing pads every day1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Silicone material (PTQ) versus saline
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Number of incontinence free days at 6 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Wexner score (mean)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 Silicone material (PTQ) versus saline
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Number of adverse effects2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 Silicone biomaterial (PTQ) versus saline injection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Serious adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Need for re-treatment at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    8.1 Dextranomer stabilised in hyaluronic acid (NASHA Dx) versus sham injection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. One injectable material versus another

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Failure (number with worse faecal incontinence)2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 hydrogel crosslinked with polyacrylamide versus porcine dermal collagen
1Risk 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
1Risk 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
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Wexner's incontinence score1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere) at 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere) at12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Quality of life index (lifestyle) at 6 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere) at 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere) at 12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Serious adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 silicone biomaterial (PTQ) versus carbon-coated spheres (Durasphere)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 3. One method of injection versus another

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Failure (number of participants with Wexner's score <50% improved)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Endoanal ultrasound guidance versus digital guidance
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Failure (number of participants global Quality of Life score <50% improved)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Endoanal ultrasound guidance versus digital guidance
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Quality of life index (lifestyle) at 6 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Endoanal ultrasound guidance versus digital guidance
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Discomfort at injection site1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Endoanal ultrasound guidance versus digital guidance
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 Endoanal ultrasound guidance versus digital guidance
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Summary of complications

AgentAuthors and YearNo of patientsInjection routeTotal volumeComplicationsNumber of adverse effects/Number of participants

Autologous fatShafik 199514Submucosal15-20mlReports that there were no complications0/14

Bernardi 19981Perianal130mlReports that there were no complications0/1

Bioplastique™/PTQ™Malouf 200110Perianal5-11.5ml4 anal canal ulcer, 1 injection site pain, 1 leakage of injected material6/10

Tjandra 200482Perianal10.0ml6 minor discomfort at injection site (4: digital guidance group, 2: ultrasound guidance group)6/82

Chan 20067PerianalNot mentionedReports that there were no complications0/7

de la Portilla 200720Perianal7.5mlNot reportedNot reported

Maeda 20076Perianal7.5ml1 recto-vaginal fistula1/6

van der Hagen 200724Perianal7.5mlNot reportedNot reported

Gett 200737Not mentionedNot mentioned4 perianal abscess required surgical drainage4/37

Siproudhis 200722Perianal7.5ml6 pain at the implant site, 2 anal inflammation8/22

Soerensen 200933Perianal7.5mlReports that there were no complications0/33

Tjandra 200920Perianal10.0ml4 bruising4/20

Bartlett 200974Perianal10.0ml9 minor complications9/74

van Wunnik 201250PerianalNot mentioned2 local giant cell foreign body reaction2/50

Bulkamid™Maeda 20085Perianalmedian 9ml (8-9)Reports that there were no complications0/5

Coaptite®Ganio 200810Perianal4ml1 leakage of Coaptite®1/10

Contigen®Kumar 199817Submucosal2mlReports that there were no complications0/17

Stojkovic 200673Submucosal5mlNot reportedNot reported

Durasphere®/ACYST-TMWeiss 20027Submucosalaverage 6.8mlNot reportedNot reported


Davis 200318Submucosalmean 1.28ml at 1-4 sites2 anal discomfort, 1 exacerbation of pruritis ani, 2 passage of injected Durasphere via anus5/18

Altomare 200833Submucosalmedian 8.8ml (2-19ml)2 anal pain, 1 Durasphere® leakage, 2 material migration5/33

Aigner 200911Perianalmean 9ml (8-12ml)Local pain (most frequent, no numbers reported), 3 passage of Durasphere®At least 3/11

Tjandra 200920Submucosal10.0ml4 bruising, 2 erosion of rectal mucosa, 1 rectal pain, 1 type III hypersensitivity8/20

Gatekeeper™ (polyacrylonitrile)Ratto 201114Perianal1 cylinder (length 21mm, diameter 1-2mm)x4Reports that there were none.0/14

NASHA™DxDehli 20074Submucosal5.6ml1 bleeding settled with compression, 1 anal pain, 1 tenesmus. All complications settled within 2-7 days after procedure.3/4

Danielson 200934Submucosal4mlPain (26% during 1st injection procedure, 55% for second treatment), 3 suspected inflammation of anal canal, 2 sensation of obstructed defaecationAt least 5/34

Graf 2011136Submucosal4-8ml128 adverse events in total. Two serious events, one prostatic abscess and one rectal abscess.128/136

Dodi 2010115Submucosalup to 4ml154 adverse events, including 20 serious events such as abscess and haemorrhage154 adverse events by 70 patients

Permacol™Smart 20057SubmucosalNot mentionedReports that there were no complications0/7

Maeda 20085Perianalmedian 15ml (15-17.5)Reports that there were no complications0/5

SalineSiproudhis 200722Perianal7.5ml2 pain at the implant site2/22

Synthetic collagenUllah 201111SubmucosalNot specifiedOne death unrelated to the treatment1/11

Teflon®Shafik 199311Submucosal10mlNot reportedNot reported

Urosurge®Feretis 20016Submucosalup to 5 balloons1 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