Plugs for containing faecal incontinence

Marije Deutekom; Annette C Dobben

doi:10.1002/14651858.CD005086.pub4

Tapones anales para tratar la incontinencia fecal

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References

Referencias de los estudios incluidos en esta revisión

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additional references
other published versions

Bond C. The anal plug: an evaluation of a novel management option for faecal incontinence. Final report to Chief Scientist Office, Scottish Executive Health Department, Edinburgh2005. [sr‐incont6653]

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Bond C, Youngson G, MacPherson I, Garrett A, Bain N, Donald S, et al. Anal plugs for the management of fecal incontinence in children and adults: a randomized control trial. Journal of Clinical Gastroenterology 2007;41(1):45‐53. [sr‐incont22554]

Norton C, Kamm MA. Anal plug for faecal incontinence. Colorectal Disease 2001;3(5):323‐7. [sr‐incont19091]

Pfrommer W, Holschneider AM, Loffler N, Schauff B, Ure BM. A new polyurethane anal plug in the treatment of incontinence after anal atresia repair. European Journal of Pediatric Surgery 2000;10(3):186‐90. [sr‐incont11013]

Van Winckel M. Clinical evaluation of a new anal medical device to achieve faecal continence in spina bifida and anal atresia patients. personal communication2005. [sr‐incont22025]

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Van Winckel M, Van Biervliet S, Van Laecke E, Hoebeke P. Is an anal plug useful in the treatment of fecal incontinence in children with spina bifida or anal atresia?. Journal of Urology 2006;176(1):342‐4. [sr‐incont22027]

Referencias adicionales

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included studies
other published versions

Borrie MJ, Davidson HA. Incontinence in institutions: costs and contributing factors. Canadian Medical Association Journal 1992;147(3):322‐8.

Brazzelli M, Shirran E, Vale L. Absorbent products for containing urinary and/or fecal incontinence in adults. Journal of Wound, Ostomy and Continence Nursing 2002;29(1):45‐54.

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Brown SR, Wadhawan H, Nelson RL. Surgery for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2013, Issue 7. [DOI: 10.1002/14651858.CD001757.pub4]

Coggrave M, Norton C, Cody JD. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database of Systematic Reviews 2014, Issue 1. [DOI: 10.1002/14651858.CD002115.pub5]

Fader M, Cottenden AM, Getliffe K. Absorbent products for moderate‐heavy urinary and/or faecal incontinence in women and men. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD007408]

Hosker G, Cody JD, Norton CC. Electrical stimulation for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD001310.pub2]

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Diseases of the Colon & Rectum 1993;36(1):77‐97.

Kamm MA. Faecal incontinence. BMJ 1998;316(7130):528‐32.

Matzel KE, Bittorf B, Stadelmaier U, Hohenberger W. Sacral nerve stimulation in the treatment of faecal incontinence. Chirurg 2003;74(1):26‐32.

Mavrantonis C, Wexner SD. A clinical approach to fecal incontinence. Journal of Clinical Gastroenterology 1998;27(2):108‐21.

Mowatt G, Glazener CMA, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD004464.pub2]

Norton C, Kamm MA. Anal plug for faecal incontinence. Colorectal Disease 2001;3(5):323‐7.

Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database of Systematic Reviews 2012, Issue 7. [DOI: 10.1002/14651858.CD002111.pub3]

Omar MI, Alexander CE. Drug treatment for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2013, Issue 6. [DOI: 10.1002/14651858.CD002116.pub2]

Perry S, Shaw C, McGrother C, Matthews RJ, Assassa RP, Dallosso H, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut 2002;50(4):480‐4.

Reference Manager Professional Edition Version 12. New York: Thomson Reuters2012.

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 4.2.5. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003.

Soffer EE, Hull T. Fecal incontinence: a practical approach to evaluation and treatment. American Journal of Gastroenterology 2000;95:1873‐80.

Toglia MR. Pathophysiology of anorectal dysfunction. Obstetrics and Gynecology Clinics of North America 1998;25(4):771‐81.

Referencias de otras versiones publicadas de esta revisión

Jump to:

included studies
additional references

Deutekom M, Dobben AC. Plugs for containing faecal incontinence. Cochrane Database of Systematic Reviews 2005, Issue 3. [DOI: 10.1002/14651858.CD005086.pub2]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Bond 2005

Methods	Randomised controlled trial (2:1)
Participants	Forty eight patients took part in the trial (28 children, age > 4 years; and 20 young adults, age 16 to 45 years)
Interventions	1. Polyurethane anal plug (Conveen, Coloplast) (two sizes) 2. no intervention
Outcomes	‐ Functional Status II‐R ‐SF‐36 ‐ a Patient‐Generated Index of Quality of Life (PGI) ‐ a Carer‐Generated Index (CGI) of Quality of Life ‐ the Dartmouth COOP Charts ‐ a condition‐ specific measure developed for the research ‐ qualitative data: advantages and disadvantages of the plug ‐ health service utilisation data ‐ costs data ‐ evaluation of education package
Notes	31 (16 children and 15 adults) allocated plugs; 17 (12 children and 5 adults) allocated to no plugs. 6 participants did not complete the trial (5 in plug group and 1 in control group).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Norton 2001b

Methods	Randomised cross‐over trial
Participants	Adult outpatients (n = 34) attending a specialist colorectal hospital after failure of previous treatment
Interventions	1. Polyurethane anal plug (Conveen, Coloplast) 37 mm diameter when open 2. Polyurethane anal plug (Conveen, Coloplast) 45 mm diameter when open
Outcomes	‐ comfort of inserting plug ‐ comfort of plug in use ‐ comfort of taking plug out ‐ capacity of controlling faecal leakage ‐ preference ‐ patient characteristics which predict when the plug will help the most
Notes	Of the 34 patients offered the plug, 4 refused as they disliked the idea, 2 failed to attend, 8 dropped out after trying first plug, because of discomfort and 9 dropped out after trying one size of plug, refusing to try the second size. 11 patients completed the protocol.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Pfrommer 2000

Methods	Randomised cross‐over trial
Participants	38 partially continent or incontinent patients following imperforate anus repair (age > 6 to 15)
Interventions	1. Polyurethane anal plug (Conveen, Coloplast) (size closed/open diameter of 14.5/38mm or 15.5/45mm; depending on anal canal diameter) 2. EFF‐EFF polyvinyl‐alcohol plug (Med. SSE‐System) (diameters ranging from 15mm to 38mm. Used size dependent on anal canal diameter)
Outcomes	‐ stool consistency ‐ awareness of repletion ‐ effectiveness of treatment ‐ feeling of security ‐ loss of plug ‐ inconvenience ‐ overall satisfaction
Notes	38 patients included. Drop‐out: ‐ 2 patients liked first tested product ‐ 6 patients found the smallest available size of the products tested first too big ‐ 2 patients reported discomfort ‐ 1 patient constantly lost one of the products ‐ 4 patients failed to complete the protocol for non‐plug related reasons
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Van Winckel 2005

Methods	Randomised cross‐over trial
Participants	7 patients (4 to 12 yrs; 3 girls and 4 boys) with high type of imperforate anus; and 9 patients with spina bifida (6 to 13 yrs, 2 girls and 7 boys)
Interventions	1. Polyurethane anal plug (Conveen, Coloplast) (size 12 or 13mm; depending on preference). 2. no intervention
Outcomes	‐ number of stools ‐ number of soiling episodes ‐ number of diapers or pads used ‐ number of plugs ‐ satisfaction
Notes	16 patients included. ‐ 2 (patients with imperforate anus) dropped‐out due to discomfort and pain ‐ 2 (patients with spina bifida) dropped out because of losing the plug
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Data and analyses

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Comparison 1. Anal plugs versus no plugs

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 General health improved ‐ adults Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.1

Comparison 1 Anal plugs versus no plugs, Outcome 1 General health improved ‐ adults.

2 Bodily pain improved ‐ adults Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.2

Comparison 1 Anal plugs versus no plugs, Outcome 2 Bodily pain improved ‐ adults.

3 Well being (adults) improved Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.3

Comparison 1 Anal plugs versus no plugs, Outcome 3 Well being (adults) improved.

3.1 Full of life

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Very nervous

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Down in the dumps

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Calm and peaceful

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 Lot of energy

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Downhearted and low

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Feel worn out

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.8 Happy

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.9 Tired

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Condition‐specific measures of faecal incontinence improved Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.4

Comparison 1 Anal plugs versus no plugs, Outcome 4 Condition‐specific measures of faecal incontinence improved.

4.1 Protection

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Rash/skin problems

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 Unpleasant odour

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 Staining/smearing

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 Bowel movement in undergarments (last two weeks)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.6 Frequency of unpleasant odours

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.7 Bowel movements in undergarments (on average day)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.8 Soiled/stained undergarment (on average day)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.9 Prevents staying away from home

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.10 Must avoid long journeys

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.11 Must always have a toilet nearby

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Stool frequency Show forest plot

Other data

No numeric data

Analysis 1.5


Study
Bond 2005	No differences were observed between control and intervention group

Comparison 1 Anal plugs versus no plugs, Outcome 5 Stool frequency.

6 Costs Show forest plot

Other data

No numeric data

Analysis 1.6


Study
Bond 2005	Little or no evidence that the plug led to significant reductions in the overall costs of care

Comparison 1 Anal plugs versus no plugs, Outcome 6 Costs.

7 Achievement of pseudo‐continence Show forest plot

Other data

No numeric data

Analysis 1.7


Study	Anal plug period	Control period
Van Winckel 2005	6/12	0/12

Comparison 1 Anal plugs versus no plugs, Outcome 7 Achievement of pseudo‐continence.

8 Intolerance of intervention Show forest plot

Other data

No numeric data

Analysis 1.8


Study	Anal plug period	Control period
Van Winckel 2005	4/16	0/16

Comparison 1 Anal plugs versus no plugs, Outcome 8 Intolerance of intervention.

Open in table viewer

Comparison 2. One type of anal plug versus another type

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Plug effectiveness: number of people with no soiling Show forest plot

Other data

No numeric data

Analysis 2.1


Study	PU plug	PVA plug
Pfrommer 2000	15/23	14/23

Comparison 2 One type of anal plug versus another type, Outcome 1 Plug effectiveness: number of people with no soiling.

2 Feeling of security Show forest plot

Other data

No numeric data

Analysis 2.2


Study	PU plug	PVA plug
Pfrommer 2000	16/23	10/23

Comparison 2 One type of anal plug versus another type, Outcome 2 Feeling of security.

3 Loss of plug Show forest plot

Other data

No numeric data

Analysis 2.3


Study	PU plug	PVA plug
Pfrommer 2000	7/23	15/23

Comparison 2 One type of anal plug versus another type, Outcome 3 Loss of plug.

4 Inconvenience Show forest plot

Other data

No numeric data

Analysis 2.4


Study	PU plug	PVA plug
Pfrommer 2000	9/23	16/23

Comparison 2 One type of anal plug versus another type, Outcome 4 Inconvenience.

5 Overall satisfaction Show forest plot

Other data

No numeric data

Analysis 2.5


Study	PU plug	PVA plug
Pfrommer 2000	17/23	8/23

Comparison 2 One type of anal plug versus another type, Outcome 5 Overall satisfaction.

Figure 1

PRISMA study flow diagram.

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Analysis 1.1

Comparison 1 Anal plugs versus no plugs, Outcome 1 General health improved ‐ adults.

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Analysis 1.2

Comparison 1 Anal plugs versus no plugs, Outcome 2 Bodily pain improved ‐ adults.

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Analysis 1.3

Comparison 1 Anal plugs versus no plugs, Outcome 3 Well being (adults) improved.

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Analysis 1.4

Comparison 1 Anal plugs versus no plugs, Outcome 4 Condition‐specific measures of faecal incontinence improved.

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Study
Bond 2005	No differences were observed between control and intervention group

Analysis 1.5

Comparison 1 Anal plugs versus no plugs, Outcome 5 Stool frequency.

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Study
Bond 2005	Little or no evidence that the plug led to significant reductions in the overall costs of care

Analysis 1.6

Comparison 1 Anal plugs versus no plugs, Outcome 6 Costs.

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Study	Anal plug period	Control period
Van Winckel 2005	6/12	0/12

Analysis 1.7

Comparison 1 Anal plugs versus no plugs, Outcome 7 Achievement of pseudo‐continence.

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Study	Anal plug period	Control period
Van Winckel 2005	4/16	0/16

Analysis 1.8

Comparison 1 Anal plugs versus no plugs, Outcome 8 Intolerance of intervention.

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Study	PU plug	PVA plug
Pfrommer 2000	15/23	14/23

Analysis 2.1

Comparison 2 One type of anal plug versus another type, Outcome 1 Plug effectiveness: number of people with no soiling.

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Study	PU plug	PVA plug
Pfrommer 2000	16/23	10/23

Analysis 2.2

Comparison 2 One type of anal plug versus another type, Outcome 2 Feeling of security.

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Study	PU plug	PVA plug
Pfrommer 2000	7/23	15/23

Analysis 2.3

Comparison 2 One type of anal plug versus another type, Outcome 3 Loss of plug.

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Study	PU plug	PVA plug
Pfrommer 2000	9/23	16/23

Analysis 2.4

Comparison 2 One type of anal plug versus another type, Outcome 4 Inconvenience.

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Study	PU plug	PVA plug
Pfrommer 2000	17/23	8/23

Analysis 2.5

Comparison 2 One type of anal plug versus another type, Outcome 5 Overall satisfaction.

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Comparison 1. Anal plugs versus no plugs

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 General health improved ‐ adults Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Bodily pain improved ‐ adults Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Well being (adults) improved Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 Full of life	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Very nervous	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Down in the dumps	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Calm and peaceful	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Lot of energy	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Downhearted and low	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.7 Feel worn out	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.8 Happy	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.9 Tired	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Condition‐specific measures of faecal incontinence improved Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Protection	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Rash/skin problems	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Unpleasant odour	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 Staining/smearing	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 Bowel movement in undergarments (last two weeks)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.6 Frequency of unpleasant odours	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.7 Bowel movements in undergarments (on average day)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.8 Soiled/stained undergarment (on average day)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.9 Prevents staying away from home	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.10 Must avoid long journeys	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.11 Must always have a toilet nearby	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Stool frequency Show forest plot			Other data	No numeric data

6 Costs Show forest plot			Other data	No numeric data

7 Achievement of pseudo‐continence Show forest plot			Other data	No numeric data

8 Intolerance of intervention Show forest plot			Other data	No numeric data

Comparison 1. Anal plugs versus no plugs

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Comparison 2. One type of anal plug versus another type

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Plug effectiveness: number of people with no soiling Show forest plot			Other data	No numeric data

2 Feeling of security Show forest plot			Other data	No numeric data

3 Loss of plug Show forest plot			Other data	No numeric data

4 Inconvenience Show forest plot			Other data	No numeric data

5 Overall satisfaction Show forest plot			Other data	No numeric data

Comparison 2. One type of anal plug versus another type

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References

Referencias de los estudios incluidos en esta revisión

Bond 2005 {unpublished data only}

Norton 2001b {published data only}

Pfrommer 2000 {published data only}

Van Winckel 2005 {unpublished data only}

Referencias adicionales

Borrie 1992

Brazzelli 2002

Brown 2013

Coggrave 2014

Fader 2008

Hosker 2007

Jorge 1993

Kamm 1998

Matzel 2003

Mavrantonis 1998

Mowatt 2007

Norton 2001a

Norton 2012

Omar 2013

Perry 2002

Reference Manager 2012

RevMan 2003 [Computer program]

Soffer 2000

Toglia 1998

Referencias de otras versiones publicadas de esta revisión

Deutekom 2005

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Data and analyses

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Cochrane Review language

Website language

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Institutional users

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