The Journal of Urology
Volume 181, Issue 1 , Pages 204-210 , January 2009

Cross-Linked Polydimethylsiloxane Injection for Female Stress Urinary Incontinence: Results of a Multicenter, Randomized, Controlled, Single-Blind Study

  • Gamal Ghoniem

      Affiliations

    • Cleveland Clinic Florida, Weston, Florida
    • Corresponding Author InformationCorrespondence: Section of Voiding Dysfunction, Female Urology and Reconstruction, Cleveland Clinic Florida, (telephone: 954-659-5188; FAX: 954-659-5189)
    • Financial interest and/or other relationship with Astellas, Coloplast, Uroplasty and Bulkamid.
    • ,
  • Jacques Corcos

      Affiliations

    • McGill Urology Associates, Montreal, Quebec, Canada
    • Financial interest and/or other relationship with Johnson&Johnson, Astellas, Purdue, Triton and Allergan.
    • ,
  • Craig Comiter

      Affiliations

    • Stanford University Medical School, Stanford, California
    • Financial interest and/or other relationship with Coloplast and Astellas.
    • ,
  • Peter Bernhard

      Affiliations

    • Urology Associates, Minneapolis, Minnesota
    • ,
  • O. Lenaine Westney

      Affiliations

    • University of Texas, Houston, Texas
    • Financial interest and/or other relationship with American Medical Systems.
    • ,
  • Sender Herschorn

      Affiliations

    • University of Toronto, Toronto, Ontario, Canada
    • Financial interest and/or other relationship with Pfizer, Astellas, Johnson&Johnson, Allergan and Lilly.

Received 19 May 2008

References 

  1. Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003;189:1275
  2. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the Country of Nord-Trondelag. J Clin Epidemiol. 2000;53:1150
  3. Lewin Group. National Women's Health Resource Center. Prevalence and Treatment Patterns of Pelvic Health Disorders Among U.S. Women. June 2007 http://www.healthywomen.org/Documents/NWHRC.PrevalenceandTreatmentPatternsPelvicHealthDisorders.report.pdfAccessed September 22, 2008
  4. Ter Muelen PH, Berghmans LCM, van Kerrebroeck PEV. A systematic review: efficacy of silicone microimplants (Macroplastique®) therapy for stress urinary incontinence in adult women. Eur Urol. 2003;44:573
  5. Harriss DR, Iacovou JW, Lemberger RJ. Peri-urethral silicone microimplants (Macroplastique) for the treatment of genuine stress incontinence. Br J Urol. 1996;78:722
  6. Buckley JF, Azmy AA, Fyfe AB, Scott R, Kirk D, Deane RF, et al. Endoscopic correction of vesico-ureteric reflux with injectable silicone microparticles. J Urol, suppl. 1993;149:259A;abstract 182
  7. Tamanini JT, D'Ancona CAL, Tadini V, Netto NR. Macroplastique implantation system for the treatment of female stress urinary incontinence. J Urol. 2003;169:2229
  8. Soliman S, Evans C. Endoscopic Macroplastique injection for the treatment of female stress incontinence: role and efficacy. African J Urol. 2001;7:45
  9. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract function (International Continence Society Committee on Standardization of Terminology). Scand J Urol Nephrol, suppl. 1988;114:5
  10. Bushnell DM, Martin ML, Summers KH, Svihra J, Lionis C, Patrick DL. Quality of life of women with urinary incontinence: cross-cultural performance of 15 language versions of the I-QOL. Qual Life Res. 2005;14:1901
  11. Hwang IK, Morikawa T. Design issues in non-inferiority/equivalence trials. Drug Inform J. 1999;33:1205
  12. Kiilholma P, Mäkinen J. Disappointing effect of endoscopic Teflon injection for female stress incontinence. Eur Urol. 1991;20:197
  13. Stenberg A, Larsson G, Johnson P, Heimer G, Ulmsten U. DiHA Dextran Copolymer, a new biocompatible material for endoscopic treatment of stress incontinent women. Acta Obstet Gynecol Scand. 1999;78:436
  14. Lightner D, Calvosa C, Andersen R, Klimberg I, Brito CG, Synder J, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere. Urology. 2001;58:12
  15. Hurtado E, McCrery R, Appell R. The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:869
  16. Radley SC, Chapple CR, Mitsogiannis IC, Glass KS. Transurethral implantation of Macroplastique for the treatment of female stress urinary incontinence secondary to intrinsic sphincter deficiency. Eur Urol. 2001;39:383
  17. Muller M, Koebele A, Deval B. Determinants of success and recurrence after suburethral free tape procedure for female urinary incontinence. J Gynecol Obstet Biol Reprod. 2007;36:19
  18. Bullock TL, Ghoniem GM, Klutke CG, Staskin DR. Advances in female stress urinary incontinence: mid-urethral slings. BJU Intl, suppl. 2006;98:32
  19. Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn. 2004;23:7
  20. Bhargava S, Chapple CR. Rising awareness of the complications of synthetic slings. Curr Opin Urol. 2004;14:317

 Study received institutional review board approval at each participating site.

PII: S0022-5347(08)02452-X

doi: 10.1016/j.juro.2008.09.032

The Journal of Urology
Volume 181, Issue 1 , Pages 204-210 , January 2009

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