Techniques in Coloproctology

, Volume 17, Issue 4, pp 389–395 | Cite as

Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents

Original Article

Abstract

Background

Stabilized non-animal hyaluronic acid/dextranomer (NASHA® Dx) gel as injectable bulking therapy has been shown to decrease symptoms of faecal incontinence, but the durability of treatment and effects and influence on quality of life (QoL) is not known. The aim of this study was to assess the effects on continence and QoL and to evaluate the relationship between QoL and efficacy up to 2 years after treatment.

Methods

Thirty-four patients (5 males, mean age 61, range 34–80) were injected with 4 × 1 ml NASHA Dx in the submucosal layer. The patients were followed for 2 years with registration of incontinence episodes, bowel function and QoL questionnaires.

Results

Twenty-six patients reported sustained improvement after 24 months. The median number of incontinence episodes before treatment was 22 and decreased to 10 at 12 months (P = 0.0004) and to 7 at 24 months (P = 0.0026). The corresponding Miller incontinence scores were 14, 11 (P = 0.0078) and 10.5 (P = 0.0003), respectively. There was a clear correlation between the decrease in the number of leak episodes and the increase in the SF-36 Physical Function score but only patients with more than 75 % improvement in the number of incontinence episodes had a significant improvement in QoL at 24 months.

Conclusions

Anorectal injection of NASHA Dx gel induces improvement of incontinence symptoms for at least 2 years. The treatment has a potential to improve QoL. A 75 % decrease in incontinence episodes may be a more accurate threshold to indicate a successful incontinence treatment than the more commonly used 50 %.

Keywords

Anal incontinence Treatment Injection therapy NASHA/Dx 

Notes

Acknowledgment

The study was supported by a grant from Q-Med AB (Uppsala, Sweden), which also provided Solesta® for the study.

Conflict of interest

Dr. W. Graf has received honoraria and travel grants from Q-Med.

References

  1. 1.
    Vaizey CJ, Kamm MA (2005) Injectable bulking agents for treating faecal incontinence. Br J Surg 92:521–527PubMedCrossRefGoogle Scholar
  2. 2.
    Hussain ZI, Lim M, Stojkovic G (2011) Systematic review of perianal implants in the treatment of faecal incontinence. Br J Surg 98:1526–1536PubMedCrossRefGoogle Scholar
  3. 3.
    Chapple CR, Haab F, Cervigni M, Dannecker C, Fianu-Jonasson A, Sultan AH (2005) An open, multicentre study of NASHA/Dx Gel (Zuidex) for the treatment of stress urinary incontinence. Eur Urol 48:488–494PubMedCrossRefGoogle Scholar
  4. 4.
    Yu RN, Roth DR (2006) Treatment of vesicoureteral reflux using endoscopic injection of nonanimal stabilized hyaluronic acid/dextranomer gel: initial experience in pediatric patients by a single surgeon. Pediatrics 118:698–703PubMedCrossRefGoogle Scholar
  5. 5.
    Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W (2009) Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum 52:1101–1106PubMedCrossRefGoogle Scholar
  6. 6.
    Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M, NASHA Dx Study Group (2011) Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised sham-controlled trial. Lancet 19:997–1003CrossRefGoogle Scholar
  7. 7.
    Gustafsson UM, Kahvecioglu B, Åström G, Ahlström H, Graf W (2001) Endoanal ultrasound or magnetic resonance imaging for preoperative assessment of anal fistula: a comparative study. Colorectal Dis 3:189–197PubMedCrossRefGoogle Scholar
  8. 8.
    Stenberg A, Larsson E, Läckgren G (2003) Endoscopic treatment with dextranomer-hyaluronic acid for vesicoureteral reflux: histological findings. J Urol 169:1109–1113PubMedCrossRefGoogle Scholar
  9. 9.
    Stenberg Å, Larsson E, Lindholm A, Ronneus B, Stenberg A, Läckgren G (1999) Injectable dextranomer-based implant: histopathology, volume changes and DNA-analysis. Scand J Urol Nephrol 33:355–361PubMedCrossRefGoogle Scholar
  10. 10.
    Österberg A, Graf W, Karlbom U, Påhlman L (1996) Evaluation of a questionnaire in the assessment of patients with faecal incontinence and constipation. Scand J Gastroenterol 31:575–580PubMedCrossRefGoogle Scholar
  11. 11.
    Miller R, Bartolo DC, Locke-Edmunds JC, Mortensen NJ (1988) Prospective study of conservative and operative treatment for faecal incontinence. Br J Surg 75:101–105PubMedCrossRefGoogle Scholar
  12. 12.
    Sullivan M, Karlsson J, Taft C (2002) SF-36 hälsoenkät: Svensk Manual och Tolkningsguide, 2:a upplagan (Swedish manual and interpretation guide, 2nd edn. Sahlgrenska University Hospital, GothenburgGoogle Scholar
  13. 13.
    de la Portilla F, Vega J, Rada R et al (2009) Evaluation by three-dimensional anal endosonography of injectable silicone biomaterial (PTQ) implants to treat fecal incontinence: long-term localization and relation with the deterioration of the continence. Tech Coloproctol 13:195–199PubMedCrossRefGoogle Scholar
  14. 14.
    Bartlett L, Ho YH (2009) PTQ™ anal implants for the treatment of faecal incontinence. Br J Surg 96:1468–1475PubMedCrossRefGoogle Scholar
  15. 15.
    Tjandra JJ, Lim JF, Hiscock R, Rajendra P (2004) Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. Dis Colon Rectum 47:2138–2146PubMedCrossRefGoogle Scholar
  16. 16.
    Soerensen MM, Lundby L, Buntzen S, Laurberg S (2009) Intersphincteric injected silicone biomaterial implants: a treatment for faecal incontinence. Colorectal Dis 11:73–76PubMedCrossRefGoogle Scholar
  17. 17.
    Altomare DF, La Torre F, Rinaldi M, Binda GA, Pescatori M (2008) Carbon-coated microbeads anal injection in outpatient treatment of minor fecal incontinence. Dis Colon Rectum 51:432–435PubMedCrossRefGoogle Scholar
  18. 18.
    Ratto C, Parello A, Donisi L et al (2011) Novel bulking agent for faecal incontinence. Br J Surg 98:1644–1652PubMedCrossRefGoogle Scholar
  19. 19.
    Maeda Y, Vaizey CJ, Kamm MA (2007) Long-term results of perianal silicone injection for faecal incontinence. Colorectal Dis 9:357–361PubMedCrossRefGoogle Scholar
  20. 20.
    Gourcerol G, Gallas S, Michot F, Denis F, Denis P, Leroi AM (2007) Sacral nerve stimulation in fecal incontinence: are there factors associated with success? Dis Colon Rectum 50:3–12PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2012

Authors and Affiliations

  • J. Danielson
    • 1
    • 2
    • 3
  • U. Karlbom
    • 1
    • 4
  • T. Wester
    • 5
  • W. Graf
    • 1
    • 4
  1. 1.Institution of Surgical SciencesUppsala UniversityUppsalaSweden
  2. 2.Institution of Women’s and Children’s HealthUppsala UniversityUppsalaSweden
  3. 3.Department of Pediatric SurgeryAkademiska SjukhusetUppsalaSweden
  4. 4.Department of SurgeryAkademiska SjukhusetUppsalaSweden
  5. 5.Department of Pediatric SurgeryKarolinska University Hospital and Karolinska InstitutetStockholmSweden

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