Skip to main content

Advertisement

SpringerLink
Log in

Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature

  • Review Article
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

Introduction and hypothesis

Polyacrylamide hydrogel (PAHG, Bulkamid®) is one of several injectable agents currently used for the treatment of women with urinary stress incontinence. Although bulking agents appear to have lower efficacy rates compared to other surgical treatments, current evidence based on large prospective or comparative studies as well as systematic reviews is limited. The purpose of this study was to conduct a systematic review on the efficacy of PAHG in the treatment of female patients with stress urinary incontinence with regard to reproducibility, feasibility, safety and clinical outcome.

Methods

We searched MEDLINE (1966–2015), Scopus (2004–2015), POPLINE (1974–2015) and ClinicalTrials.gov (2008–2015) along with reference lists of electronically retrieved studies. Observational studies, prospective, retrospective and randomized controlled studies were included. Two reviewers independently selected studies, assessed the risk of bias and tabulated data to structured forms.

Results

We included 8 studies, which enrolled a total of 767 patients who received treatment with PAHG. We found that 186 of 767 women (24.3 %, range 12–35 %) required reinjection in order to achieve adequate efficacy. The most frequent adverse effects were pain at the site of injection (4–14 %) and urinary tract infections (3–7 %). Both the number of incontinence episodes/24 h and the number of ml/24 h were significantly reduced 1 year following treatment and the quality of life of patients was significantly improved.

Conclusions

PAHG is a safe intervention for treating women with stress urinary incontinence, but repeat injections are often required. Further research is mandated in the field in order to compare its efficacy to other bulking agents.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. National Institute for Health and Care Excellence (2013) NICE guidelines [CG171]. Urinary incontinence: the management of urinary incontinence in women. http://guidance.nice.org.uk/CG171

  2. Kirchin V, Page T, Keegan PE, Atiemo K, Cody JD, McClinton S (2012) Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev 2:CD003881. doi:10.1002/14651858.CD003881.pub3

    PubMed  Google Scholar 

  3. Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girão MJ (2014) Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J 25(10):1343–1348

    Article  PubMed  Google Scholar 

  4. Committee Opinion No. 603: Evaluation of uncomplicated stress urinary incontinence in women before surgical treatment (2014). Obstet Gynecol 123(6):1403–1407

  5. Ter Meulen PH, Berghmans LC, van Kerrebroeck PE (2003) Systematic review: efficacy of silicone microimplants (Macroplastique) therapy for stress urinary incontinence in adult women. Eur Urol 44(5):573–582

  6. Klarskov N, Lose G (2008) Urethral injection therapy: what is the mechanism of action? Neurourol Urodyn 27(8):789–792

    Article  PubMed  Google Scholar 

  7. Fatton B, Savary D, Velemir L (2009) Obstructive suburethral mass following injection of dextranomer/hyaluronic acid copolymer. Int J Gynaecol Obstet 104(1):73–74

    Article  PubMed  Google Scholar 

  8. Loisel C, Secco M, Rocher-Barrat A, Caremel R, Grise P (2008) Periurethral pseudocysts following urethral injections of Zuidex: review of the literature. Prog Urol 18(13):1038–1043

    Article  CAS  PubMed  Google Scholar 

  9. Madjar S, Sharma AK, Waltzer WC, Frischer Z, Secrest CL (2006) Periurethral mass formations following bulking agent injection for the treatment of urinary incontinence. J Urol 175(4):1408–1410

    Article  CAS  PubMed  Google Scholar 

  10. Kotb AF, Campeau L, Corcos J (2009) Urethral bulking agents: techniques and outcomes. Curr Urol Rep 10(5):396–400

    Article  PubMed  Google Scholar 

  11. Lose G, Mouritsen L, Nielsen JB (2006) A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. BJU Int 98(1):100–104

    Article  CAS  PubMed  Google Scholar 

  12. Zarini E, Supino R, Pratesi G, Laccabue D, Tortoreto M, Scanziani E, Ghisleni G, Paltrinieri S, Tunesi G, Nava M (2004) Biocompatibility and tissue interactions of a new filler material for medical use. Plast Reconstr Surg 114(4):934–942

    Article  PubMed  Google Scholar 

  13. Bello G, Jackson IT, Keskin M, Kelly C, Dajani K, Studinger R, Kim EM, Lincoln D, Silberberg B, Lee A (2007) The use of polyacrylamide gel in soft-tissue augmentation: an experimental assessment. Plast Reconstr Surg 119(4):1326–1336

    Article  CAS  PubMed  Google Scholar 

  14. Christensen LH, Breiting VB, Aasted A, Jørgensen A, Kebuladze I (2003) Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg 111(6):1883–1890

    Article  PubMed  Google Scholar 

  15. Christensen LH, Nielsen JB, Mouritsen L, Sørensen M, Lose G (2008) Tissue integration of polyacrylamide hydrogel: an experimental study of periurethral, perivesical, and mammary gland tissue in the pig. Dermatol Surg 34(Suppl 1):S68–S77, discussion S77

    CAS  PubMed  Google Scholar 

  16. Lose G, Sørensen HC, Axelsen SM, Falconer C, Lobodasch K, Safwat T (2010) An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence. Int Urogynecol J 21(12):1471–1477

    Article  PubMed Central  PubMed  Google Scholar 

  17. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 339:b2700

    Article  PubMed Central  PubMed  Google Scholar 

  18. Toozs-Hobson P, Al-Singary W, Fynes M, Tegerstedt G, Lose G (2012) Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence. Int Urogynecol J 23(10):1373–1378

    Article  PubMed Central  PubMed  Google Scholar 

  19. Leone Roberti Maggiore U, Alessandri F, Medica M, Gabelli M, Venturini PL, Ferrero S (2013) Outpatient periurethral injections of polyacrylamide hydrogel for the treatment of female stress urinary incontinence: effectiveness and safety. Arch Gynecol Obstet 288(1):131–137

    Article  PubMed  Google Scholar 

  20. Martan A, Masata J, Svabik K, Krhut J (2014) Transurethral injection of polyacrylamide hydrogel (Bulkamid®) for the treatment of female stress or mixed urinary incontinence. Eur J Obstet Gynecol Reprod Biol 178:199–202

    Article  CAS  PubMed  Google Scholar 

  21. Trutnovsky G, Tamussino K, Greimel E, Bjelic-Radisic V (2011) Quality of life after periurethral injection with polyacrylamide hydrogel for stress urinary incontinence. Int Urogynecol J 22(3):353–356

    Article  PubMed  Google Scholar 

  22. Beraru A, Droupy S, Wagner L, Soustelle L, Muyschondt C, Ben Naoum K, Grés P, Boukaram M, Costa P (2014) Efficacy of periurethral injections of polyacrylamide hydrogel (Bulkamid®) and quality of life of patients with urinary incontinence due to sphincter deficiency (IUE-IS). Prog Urol 24(8):501–510

    Article  CAS  PubMed  Google Scholar 

  23. Sokol ER, Karram MM, Dmochowski R (2014) Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol 192(3):843–849

    Article  CAS  PubMed  Google Scholar 

  24. Vecchioli-Scaldazza CV, Smaali C, Morosetti C, Azizi B, Giannubilo W, Ferrara V (2014) Polyacrylamide hydrogel (Bulkamid®) in female patients of 80 or more years with urinary incontinence. Int Braz J Urol 40(1):37–43

    PubMed  Google Scholar 

  25. Davis NF, Kheradmand F, Creagh T (2013) Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynecol J 24(6):913–919

    Article  PubMed  Google Scholar 

  26. Martan A, Masata J, Svabik K, El-Haddad R, Hubka P (2011) Transurethral injection of polyacrylamide hydrogel (Bulkamid®) for the treatment of female stress urinary incontinence and changes in the cure rate over time. Ceska Gynekol 76(6):476–481

    CAS  PubMed  Google Scholar 

  27. Cloutier J, Blais AS, Moore K, Bolduc S (2013) Prospective study using a new bulking agent for the treatment of vesicoureteral reflux: polyacrylamide hydrogel. J Urol 190(3):1034–1037

    Article  CAS  PubMed  Google Scholar 

  28. Mohr S, Siegenthaler M, Mueller MD, Kuhn A (2013) Bulking agents: an analysis of 500 cases and review of the literature. Int Urogynecol J 24(2):241–247

    Article  PubMed  Google Scholar 

  29. Leone Roberti Maggiore U, Alessandri F, Medica M, Gabelli M, Venturini PL, Ferrero S (2012) Periurethral injection of polyacrylamide hydrogel for the treatment of stress urinary incontinence: the impact on female sexual function. J Sex Med 9(12):3255–3263

    Article  PubMed  Google Scholar 

  30. Gopinath D, Smith ARB, Reid FM (2012) Periurethral abscess following polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence. Int Urogynecol J 23:1645–1648

    Article  CAS  PubMed  Google Scholar 

Download references

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Urogynaecology Unit, St. George’s University Hospitals NHS Foundation Trust, London, SW17 0QT, UK

    Anushuya Devi Kasi, Azar Khunda & Stergios K. Doumouchtsis

  2. Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Medical School, University of Athens, Athens, Greece

    Vasilios Pergialiotis, Despina N. Perrea & Stergios K. Doumouchtsis

Authors
  1. Anushuya Devi Kasi
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Vasilios Pergialiotis
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Despina N. Perrea
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Azar Khunda
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Stergios K. Doumouchtsis
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Anushuya Devi Kasi.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kasi, A.D., Pergialiotis, V., Perrea, D.N. et al. Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J 27, 367–375 (2016). https://doi.org/10.1007/s00192-015-2781-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00192-015-2781-y

Keywords

Search

Navigation