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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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Graf 2011 {published data only}
  • Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet 2011;377(9770):997-1003. [: 41243]
  • NCT00605826. A randomized, blinded, multicenter study to evaluate NASHA/Dx for the treatment of fecal incontinence. ClinicalTrials.gov 2009.
Maeda 2008 {published data only}
Siproudhis 2007 {published data only}
Tjandra 2004 {published data only}
  • Tjandra JJ, Han WR, Rajendra P. Injectable silicone biomaterial for faecal incontinence due to internal sphincter dysfunction is effective (Abstract). Proceedings of the American Society of Colon and Rectal Surgeons (ASCRS), Dallas, TX, 8-13 May 2004. 2004:178.
  • Tjandra JJ, Lim JF, Hiscock R, Rajendra P. Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. Diseases of the Colon and Rectum 2004;47(12):2138-46.
Tjandra 2009 {published data only}
  • Chan M. Injectable silicone biomaterial (PTQTM) is more effective than carbon-coated beads (Durasphere©) in treating passive faecal incontinence: a randomised trial. ControlledTrials.com (www.controlled-trials.com) [accessed 2 February 2009] 2006.
  • Tjandra JJ, Chan MK, Yeh HC. Injectable silicone biomaterial (PTQ) is more effective than carbon-coated beads (Durasphere) in treating passive faecal incontinence-a randomized trial. Colorectal Disease 2009;11(4):382-9.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Dehli 2007 {published data only}
  • Dehli T, Lindsetmo RO, Mevik K, Vonen B. [Anal incontinence--assessment of a new treatment]. [Norwegian]. Tidsskrift for Den Norske Laegeforening 2007;127(22):2934-6.

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Dehli 2009 {published data only}
  • 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.
Draganic 2008 {published data only}
  • 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.
EUCTR2010-021463-32-AT 2011 {published data only}
  • 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 Register 2011.
Michot 2012 {published data only}
  • Michot F. Myoblast for Anal Incontinence (MIAS) (http://clinicaltrials.gov/show/NCT01523522). ClinicalTrials.gov 2012.
NCT00762047 2009 {published data only}
  • NCT00762047. A prospective, multi-center, randomized, blinded study to evaluate Durasphere FI for the treatment of fecal incontinence. ClinicalTrials.gov 2009.
Norderval 2012 {published data only}
  • 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.gov 2012.
Smart 2008 {published data only}

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Aigner 2009
  • Aigner F, Conrad F, Margreiter R, Oberwalder M. Anal submucosal carbon bead injection for treatment of idiopathic fecal incontinence: a preliminary report. Diseases of the Colon and Rectum 2009;52(2):293-8.
Altomare 2008
  • Altomare DF, La Torre F, Rinaldi M, Binda GA, Pescatori M. Carbon-coated microbeads anal injection in outpatient treatment of minor fecal incontinence. Diseases of the Colon and Rectum 2008;51(4):432-5.
Bartlett 2009
Bernardi 1998
Bharucha 2010
  • Bharucha AE, Zinsmeister AR, Schleck CD, Melton LJ 3rd. Bowel disturbances are the most important risk factors for late onset fecal incontinence: a population-based case-control study in women. Gastroenterology 2010;139(5):1559-66.
Brown 2010
Chan 2006
Cheetham 2003
  • Cheetham M, Brazzelli M, Norton C, Glazener CM. Drug treatment for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2003, Issue 3. [DOI: 10.1002/14651858.CD002116]
Christiansen 1999
Da Silva 2003
Danielson 2009
  • Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Diseases of the Colon and Rectum 2009;52(6):1101-6.
Davis 2003
de la Portilla 2007
  • de la Portilla F, Fernandez A, Leon E, Rada R, Cisneros N, Maldonado VH, et al. Evaluation of the use of PTQ(TM) implants for the treatment of incontinent patients due to internal anal sphincter dysfunction. Colorectal Disease 2008;10(1):89-94.
Deutekom 2012
Dodi 2010
  • Dodi G, Jongen J, de la Portilla F, Raval M, Altomare DF, Lehur PA. An open-label, noncomparative, multicenter study to evaluate efficacy and safety of NASHA/Dx gel as a bulking agent for the treatment of fecal incontinence. Gastroenterology Research and Practice 2010;2010:Article ID: 467136. [DOI: 10.1155/2010/467136; PUBMED: 21234379]
Engel 1995
Fader 2008
Felt-Bersma 1996
  • Felt-Bersma RJ, Cuesta MA, Koorevaar M. Anal sphincter repair improves anorectal function and endosonographic image. A prospective clinical study. Diseases of the Colon and Rectum 1996;39(8):878-85.
Feretis 2001
  • Feretis C, Benakis P, Dailianas A, Dimopoulos C, Mavrantonis C, Stamou KM, et al. Implantation of microballoons in the management of fecal incontinence. Diseases of the Colon and Rectum 2001;44(11):1605-9.
Frudinger 2010
  • Frudinger A, Kölle D, Schwaiger W, Pfeifer J, Paede J, Halligan S. Muscle-derived cell injection to treat anal incontinence due to obstetric trauma: pilot study with 1 year follow-up. Gut 2010;59(1):55-61.
Ganio 2008
  • Ganio E, Marino F, Giani I, Luc AR, Clerico G, Novelli E, et al. Injectable synthetic calcium hydroxylapatite ceramic microspheres (Coaptite) for passive fecal incontinence. Techniques in Coloproctology 2008;12(2):99-102.
Gett 2007
  • Gett RM, Gyorki D, Keck J, Chen F, Johnston M. Managing faecal incontinence: the role of PTQ injection. ANZ Journal of Surgery 2007;77(s1):A16.
    Direct Link:
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. Vol. Available from www.cochranehandbook.org.
Hosker 2007
Hussain 2011
Kumar 1998
  • Kumar D, Benson MJ, Bland JE. Glutaraldehyde cross-linked collagen in the treatment of faecal incontinence. British Journal of Surgery 1998;85(7):978-9.
Leroi 1997
Lindsey 2004
Luo 2010
Maeda 2007
Malouf 2001
  • Malouf AJ, Vaizey CJ, Norton CS, Kamm MA. Internal anal sphincter augmentation for fecal incontinence using injectable silicone biomaterial. Diseases of the Colon and Rectum 2001;44(4):595-600.
Morgan 1997
Mowatt 2007
NICE 2007
  • National Collaborating Centre for Acute Care and NHS National Institute for Health and Clinical Excellence (NICE). Faecal incontinence: the management of faecal incontinence in adults (National Clinical Guideline). London, UK: National Collaborating Centre for Acute Care at The Royal College of Surgeons of England. 2007; Vol. Report number: CG49, 2007.
Norton 2012
  • Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Systematic Reviews 2012;7:CD002111.
Rao 2004
Ratto 2011
Shafik 1993
Shafik 1995
Smart 2005
  • Smart N, Aspey H, Richardson D, Plusa S, Mercer-Jones M. Submucosal injections with Permacol for faecal incontinence. Colorectal Disease 2005;7(s2):59.
Soerensen 2009
Stojkovic 2006
Ullah 2011
  • Ullah S, Tayyab M, Arsalani-Zadeh R, Duthie GS. Injectable anal bulking agent for the management of faecal incontinence. Journal of the College of Physicians and Surgeons--Pakistan 2011;21(4):227-9.
Vaizey 1997
van der Hagen 2007
van Wunnik 2012
  • van Wunnik B, Driessen A, Baeten C. Local giant cell foreign body reaction after silicone injection for fecal incontinence in humans: two case reports. Techniques in Coloproctology 2012;16(5):395-7. [PUBMED: 21695441]
Weiss 2002
  • Weiss EG, Efron JF, Nogueras JJ, Wexner SD. Submucosal injection of carbon coated beads is a successful and safe office-based treatment for fecal incontinence [abstract]. Diseases of the Colon and Rectum 2002;45:A46-7.
Wexner 1996
  • Wexner SD, Gonzalez-Padron A, Rius J, Teoh TA, Cheong DM, Nogueras JJ, et al. Stimulated gracilis neosphincter operation. Initial experience, pitfalls, and complications. Diseases of the Colon and Rectum 1996;39(9):957-64.
Wheeler 2007
  • Wheeler TL 2nd, Richter HE. Delivery method, anal sphincter tears and fecal incontinence: new information on a persistent problem. Current Opinion in Obstetrics & Gynecology 2007;19(5):474-9.
Whitehead 2009
  • Whitehead WE, Borrud L, Goode PS, Meikle S, Mueller ER, Tuteja A, Weidner A, Weinstein M, Ye W, Pelvic Floor Disorders Network. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology 2009;137(2):512-7.

References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Maeda 2010