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Emerging periurethral bulking agents for female stress urinary incontinence: is new necessarily better?

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Abstract

Bulking therapy for stress urinary incontinence in women continues to evolve from the standpoint of material science. Several new materials have recently been subjected to clinical trials with the aim of assessing efficacy and safety of these agents for possible device registration. These new additions run the gamut of biologic to synthetic materials, including re-engineered carbon-coated zirconium beads, ethylene vinyl copolymer, calcium hydroxylapatite, silicone, and hyaluronic acid. Trial design and results reporting for bulking agents has also evolved, with the addition of quality-of-life and patient approbation assessments now being included with outcomes for incontinence reduction and adverse events recording. The new agents and recent studies are reviewed within a context of the prior evidence that has supported the use of the bulking strategy for management of symptomatic stress incontinence. Several recent trials have also compared bulking agents with surgical interventions from effectiveness, approbation, and cost vantage points so as to better determine the reasonability of bulking agent use in an era of minimally invasive incontinence surgery.

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References and Recommended Reading

  1. Gasquet I, Tcherny-Lessenot S, Gaudebout P, et al.: Influence of the severity of stress urinary incontinence on quality of life, health care seeking, and treatment: a national cross-sectional survey. Eur Urol 2006, in press.

  2. Subak LL, Brown JS, Kraus SR, et al.: The “costs” of urinary incontinence for women. Obstet Gynecol 2006, 107:908–916.

    PubMed  Google Scholar 

  3. Lightner DJ, Itano NB, Sweat SD, et al.: Injectable agents: present and future. Curr Urol Rep 2002, 3:408–413.

    Article  PubMed  Google Scholar 

  4. Corcos J, Collet JP, Shapiro S, et al.: Multicenter, randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology 2005, 65:898–904. Important recent article evaluating the role of bulking agents in women considering surgery.

    Article  PubMed  CAS  Google Scholar 

  5. Murless BC: The injection treatment of stress incontinence. J Obstet Gynaecol Br Emp 1938, 45:521–524.

    Google Scholar 

  6. Quackles R: Deux incontinences apres adenomectomie gueries par injection de paraffine dans le perinee. Acta Urol Belg 1955, 23:259–262.

    Google Scholar 

  7. Sachse S: Treatment of urinary incontinence with sclerosing solutions: indications, results, complications. Urol Int 1963, 15:225–229.

    Article  PubMed  CAS  Google Scholar 

  8. Politano VA, Small MP, Harper JM, Lynne CM: Periurethral teflon injection for urinary incontinence. J Urol 1974, 111:180–183.

    PubMed  CAS  Google Scholar 

  9. van Kerrebroeck P, ter Meulen F, Farrelly E, et al.: Treatment of stress urinary incontinence: recent developments in the role of urethral injection. Urol Res 2003, 30:356–362.

    PubMed  Google Scholar 

  10. Dmochowski R, Appell RA: Advancements in minimally invasive treatments for female stress urinary incontinence: radiofrequency and bulking agents. Curr Urol Rep 2003, 4:350–355.

    Article  PubMed  Google Scholar 

  11. Itano NB, Sweat SD, Lightner DJ: The use of bulking agents for stress incontinence. AUA Update Series 2002, XXI:34–39.

    Google Scholar 

  12. Yokoyama T, Huard J, Chancellor MB: Myoblast therapy for stress urinary incontinence and bladder dysfunction. World J Urol 2000, 18:56–61.

    Article  PubMed  CAS  Google Scholar 

  13. Leach GE, Dmochowski RR, Appell RA, et al.: Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol 1997, 158:875–880.

    Article  PubMed  CAS  Google Scholar 

  14. Winters JC, Appell R: Periurethral injection of collagen in the treatment of intrinsic sphincteric deficiency in the female patient. Urol Clin North Am 1995, 22:673–678.

    PubMed  CAS  Google Scholar 

  15. Monga AK, Stanton SL: Urodynamics: prediction, outcome, and analysis of mechanism for cure of stress incontinence by periurethral collagen. Br J Obstet Gynaecol 1997, 104:158–162.

    PubMed  CAS  Google Scholar 

  16. Corcos J, Fournier C: Periurethral collagen injection for the treatment of female stress urinary incontinence: 4-year follow-up results. Urology 1999, 54:815–818.

    Article  PubMed  CAS  Google Scholar 

  17. Elsergany R, Ghoniem GM: Collagen injection for intrinsic sphincteric deficiency in men: a reasonable option in selected patients. J Urol 1998, 159:1504–1506.

    Article  PubMed  CAS  Google Scholar 

  18. Faerber GJ: Endoscopic collagen injection therapy in elderly women with type I stress urinary incontinence. J Urol 1996, 155:512–514.

    Article  PubMed  CAS  Google Scholar 

  19. Eckford SD, Abrams P: Para-urethral collagen implantation for female stress incontinence. Br J Urol 1991, 68:586–589.

    Article  PubMed  CAS  Google Scholar 

  20. Kieswetter H, Fischer M, Wober L, Flamm J: Endoscopic implantation of collagen (GAX) for the treatment of urinary incontinence. Br J Urol 1992, 69:22–25.

    PubMed  CAS  Google Scholar 

  21. Monga AK, Robinson D, Stanton SL: Periurethral collagen injections for genuine stress incontinence: a 2-year followup. Br J Urol 1995, 76:156–160.

    PubMed  CAS  Google Scholar 

  22. O’Connell HE, McGuire EJ, Aboseif S, Usui A: Transurethral collagen therapy in women. J Urol 1995, 154:1463–1465.

    Article  PubMed  CAS  Google Scholar 

  23. Blaivas JG, Olsson CA: Stress incontinence: classification and surgical approach. J Urol 1988, 139:727–731.

    PubMed  CAS  Google Scholar 

  24. McGuire EJ, Lytton B, Kohorn EI, Pepe V: The value of urodynamic testing in stress urinary incontinence. J Urol 1980, 124:256–258.

    PubMed  CAS  Google Scholar 

  25. English SF, Amundsen CL, McGuire EJ: Bladder neck competency at rest in women with incontinence. J Urol 1999, 161:578–580.

    Article  PubMed  CAS  Google Scholar 

  26. Steele AC, Kohli N, Karram MM: Periurethral collagen injection for stress incontinence with and without urethral hypermobility. Obstet Gynecol 2000, 95:327–331.

    Article  PubMed  CAS  Google Scholar 

  27. Herschorn S, Radomski SB: Collagen injections for genuine stress urinary incontinence: patient selection and durability. Int Urogynecol J Pelvic Floor Dysfunct 1997, 8:18–24.

    Article  PubMed  CAS  Google Scholar 

  28. Contigen® Bard® Collagen Implant (Package Insert). Covington, GA: CR Bard; 1998.

  29. Kershen RT, Atala A: New advances in injectable therapies for the treatment of incontinence and vesicoureteral reflux. Urol Clin North Am 1999, 26:81–94, viii.

    Article  PubMed  CAS  Google Scholar 

  30. Kligman AM, Armstrong RC: Histologic response to intradermal Zyderm and Zyplast (glutaraldehyde crosslinked) collagen in humans. J Dermatol Surg Oncol 1986, 12:351–357.

    PubMed  CAS  Google Scholar 

  31. Stegman SJ: Injectable collagen. Plast Reconstr Surg 1987, 80:866.

    Article  PubMed  CAS  Google Scholar 

  32. Stegman SJ, Chu S, Bensch K, Armstrong R: A light and electron microscopic evaluation of Zyderm collagen and Zyplast implants in aging human facial skin: a pilot study. Arch Dermatol 1987, 123:1644–1649.

    Article  PubMed  CAS  Google Scholar 

  33. Kershen RT, Dmochowski RR, Appell RA: Beyond collagen: injectable therapies for the treatment of female stress urinary incontinence in the new millennium. Urol Clin North Am 2002, 29:559–574.

    Article  PubMed  Google Scholar 

  34. Agency for Health Care Policy and Research: Clinical Practice Guidelines. Urinary Incontinence in Adults. Rockville, MD: Department of Health and Human Services; 1996.

  35. Dmochowski RR, Appell RA: Injectable agents in the treatment of stress urinary incontinence in women: Where are we now? Urology 2000, 56(suppl 1):32–40.

    Article  PubMed  CAS  Google Scholar 

  36. Cross CA, English SF, Cespedes RD, McGuire EJ: A followup on transurethral collagen injection therapy for urinary incontinence. J Urol 1998, 159:106–108.

    Article  PubMed  CAS  Google Scholar 

  37. Khullar V, Cardozo LD, Abbott D, Anders K: GAX collagen in the treatment of urinary incontinence in elderly women: a 2-year follow up. Br J Obstet Gynaecol 1997, 104:96–99.

    PubMed  CAS  Google Scholar 

  38. Winters JC, Chiverton A, Scarpero HM, Prats LJ Jr: Collagen injection therapy in elderly women: long-term results and patient satisfaction. Urology 2000, 55:856–861.

    Article  PubMed  CAS  Google Scholar 

  39. Stothers L, Goldenberg SL, Leone EF: Complications of periurethral collagen injection for stress urinary incontinence. J Urol 1998, 159:806–807.

    Article  PubMed  CAS  Google Scholar 

  40. Santarosa RP, Blaivas JG: Periurethral injection of autologous fat for the treatment of sphincteric incontinence. J Urol 1994, 151:607–611.

    PubMed  CAS  Google Scholar 

  41. Haab F, Zimmern PE, Leach GE: Urinary stress incontinence due to intrinsic sphincteric deficiency: experience with fat and collagen periurethral injections. J Urol 1997, 157:1283–1286.

    Article  PubMed  CAS  Google Scholar 

  42. Lee PE, Kung RC, Drutz HP: Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized, double-blind, controlled trial. J Urol 2001, 165:153–158.

    Article  PubMed  CAS  Google Scholar 

  43. Pannek J, Brands FH, Senge T: Particle migration after transurethral injection of carbon coated beads for stress urinary incontinence. J Urol 2001, 166:1350–1353.

    Article  PubMed  CAS  Google Scholar 

  44. Madjar S, Covington-Nichols C, Secrest CL: New periurethral bulking agent for stress urinary incontinence: modified technique and early results. J Urol 2003, 170:2327–2329.

    Article  PubMed  Google Scholar 

  45. Lightner D, Calvosa C, Andersen R, et al.: A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, doubleblind study of Durasphere. Urology 2001, 58:12–15.

    Article  PubMed  CAS  Google Scholar 

  46. Chrouser KL, Fick F, Goel A, et al.: Carbon coated zirconium beads in beta-glucan gel and bovine glutaraldehyde cross-linked collagen injections for intrinsic sphincter deficiency: continence and satisfaction after extended follow-up. J Urol 2004, 171:1152–1155. Long-term durability trial results of initial registration study for carbon-coated zirconium beads.

    Article  PubMed  CAS  Google Scholar 

  47. Ghoniem GM, Khater U: Urethral prolapse after durasphere injection. Int Urogynecol J Pelvic Floor Dysfunct 2006, 17:297–298.

    Article  PubMed  Google Scholar 

  48. Radley SC, Chapple CR, Lee JA: Transurethral implantation of silicone polymer for stress incontinence: evaluation of a porcine model and mechanism of action in vivo. BJU Int 2000, 85:646–650.

    Article  PubMed  CAS  Google Scholar 

  49. Henly DR, Barrett DM, Weiland TL, et al.: Particulate silicone for use in periurethral injections: local tissue effects and search for migration. J Urol 1995, 153:2039–2043.

    Article  PubMed  CAS  Google Scholar 

  50. Henalla SM, Hall V, Duckett JR, et al.: A multicentre evaluation of a new surgical technique for urethral bulking in the treatment of genuine stress incontinence. BJOG 2000, 107:1035–1039.

    Article  PubMed  CAS  Google Scholar 

  51. Tamanini JT, D’Ancona CA, Tadini V, Netto NR Jr: Macroplastique implantation system for the treatment of female stress urinary incontinence. J Urol 2003, 169:2229–2233.

    Article  PubMed  Google Scholar 

  52. Harriss DR, Iacovou JW, Lemberger RJ: Peri-urethral silicone microimplants (Macroplastique) for the treatment of genuine stress incontinence. Br J Urol 1996, 78:722–728.

    PubMed  CAS  Google Scholar 

  53. Usman F, Henalla S: A single transurethral Macroplastique injection as primary treatment for stress incontinence in women. J Obstet Gynaecol 1998, 18:56–60.

    Article  PubMed  CAS  Google Scholar 

  54. Sheriff MK, Foley S, McFarlane J, et al.: Endoscopic correction of intractable stress incontinence with silicone micro-implants. Eur Urol 1997, 32:284–288.

    PubMed  CAS  Google Scholar 

  55. Maher CF, O’Reilly BA, Dwyer PL, et al.: Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective, randomized, controlled trial. BJOG 2005, 112:797–801. Randomized trial evaluating bulking strategies compared with surgical intervention.

    Article  PubMed  Google Scholar 

  56. Drobeck HP, Rothstein SS, Gumaer KI, et al.: Histologic observation of soft tissue responses to implanted, multifaceted particles and discs of hydroxylapatite. J Oral Maxillofac Surg 1984, 42:143–149.

    Article  PubMed  CAS  Google Scholar 

  57. Misiek DJ, Kent JN, Carr RF: Soft tissue responses to hydroxylapatite particles of different shapes. J Oral Maxillofac Surg 1984, 42:150–160.

    Article  PubMed  CAS  Google Scholar 

  58. Pettis GY, Kaban LB, Glowacki J: Tissue response to composite ceramic hydroxyapatite/demineralized bone implants. J Oral Maxillofac Surg 1990, 48:1068–1074.

    Article  PubMed  CAS  Google Scholar 

  59. Mayer R, Lightfoot M, Jung I: Preliminary evaluation of calcium hydroxylapatite as a transurethral bulking agent for stress urinary incontinence. Urology 2001, 57:434–438.

    Article  PubMed  CAS  Google Scholar 

  60. Lightner DJ: Review of the available urethral bulking agents. Curr Opin Urol 2002, 12:333–338.

    Article  PubMed  Google Scholar 

  61. Solomon LZ, Birch BR, Cooper AJ, et al.: Nonhomologous bioinjectable materials in urology: ‘size matters’? BJU Int 2000, 85:641–645.

    Article  PubMed  CAS  Google Scholar 

  62. Dmochowski RR, Appell RA, Klimberg I, Mayer R: Initial clinical results from coaptite injection for stress urinary incontinence comparative clinical study. Presented at the International Continence Society 32nd Annual Meeting. Heidelberg, Germany: August 28–30, 2002.

  63. Mayer RD, Appell RA, Dmochowski RR: A 52-week trial of calcium hydroxylapatite vs. bovine dermal collagen for treatment of stress urinary incontinence. Presented at the Society of Female Urology and Urodynamics Annual Meeting. Grand Bahamas: February 22–26, 2006.

  64. Palma PC, Riccetto CL, Martins MH, et al.: Massive prolapse of the urethral mucosa following periurethral injection of calcium hydroxylapatite for stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2005:1–2 [Epub ahead of print].

  65. Dmochowski RR, Appell RA, Bent AE, et al.: Multicenter, randomized, controlled study to evaluate Uryx urethral bulking agent in treating female stress urinary incontinence. Presented at the American Urological Association Annual Meeting. San Francisco: May 8–13, 2004.

  66. Tegress Urethral Implant, Package Insert. Covington, GA: Bard; 2005.

  67. Stenberg A, Larsson E, Lindholm A, et al.: Injectable dextranomer-based implant: histopathology, volume changes and DNA-analysis. Scand J Urol Nephrol 1999, 33:355–361.

    Article  PubMed  CAS  Google Scholar 

  68. Lackgren G, Wahlin N, Skoldenberg E, Stenberg A:Long-term follow-up of children treated with dextranomer/ hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2001, 166:1887–1892.

    Article  PubMed  CAS  Google Scholar 

  69. Lackgren G, Wahlin N, Stenberg A: Endoscopic treatment of children with vesico-ureteric reflux. Acta Paediatr Suppl 1999, 88:62–71.

    Article  PubMed  CAS  Google Scholar 

  70. Stenberg AM, Sundin A, Larsson BS, et al.: Lack of distant migration after injection of a 125iodine labeled dextranomer based implant into the rabbit bladder. J Urol 1997, 158:1937–1941.

    Article  PubMed  CAS  Google Scholar 

  71. van Kerrebroeck P, ter Meulen F, Larsson G, et al.: Efficacy and safety of a novel system (NASHA/Dx copolymer using the Implacer device) for treatment of stress urinary incontinence. Urology 2004, 64:276–281.

    Article  PubMed  Google Scholar 

  72. van Kerrebroeck P, ter Meulen F, Larsson G, et al.: Treatment of stress urinary incontinence using a copolymer system: impact on quality of life. BJU Int 2004, 94:1040–1043. Analysis of quality-of-life impact of bulking therapy in patients receiving a new bulking agent.

    Article  PubMed  Google Scholar 

  73. Chapple CR, Haab F, Cervigni M, et al.: An open, multicentre study of NASHA/Dx Gel (Zuidex) for the treatment of stress urinary incontinence. Eur Urol 2005, 48:488–494. Multcentric trial of a new agent, using active comparator randomization.

    PubMed  CAS  Google Scholar 

  74. Stenberg AM, Larsson G, Johnson P: Urethral injection for stress urinary incontinence: long-term results with dextranomer/hyaluronic acid copolymer. Int Urogynecol J Pelvic Floor Dysfunct 2003, 14:335–338.

    Article  PubMed  CAS  Google Scholar 

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Correspondence to Roger R. Dmochowski MD.

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Starkman, J.S., Scarpero, H. & Dmochowski, R.R. Emerging periurethral bulking agents for female stress urinary incontinence: is new necessarily better?. Curr Urol Rep 7, 405–413 (2006). https://doi.org/10.1007/s11934-006-0012-2

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