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

Journal of Urology

Volumn 181, Issue 1, 2009, Pages 204-210

  Ghoniem, Gamal ^a   Corcos, Jacques ^c   Comiter, Craig ^e   Bernhard, Peter ^b   Westney, O Lenaine ^f   Herschorn, Sender ^d  

^a DEPARTMENT OF COLORECTAL SURGERY   (United States)

^b Urology Associates Ltd   (United States)

^c Douglas Institute Research Center   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF TEXAS   (United States)

Author keywords

female; injections; prostheses and implants; stress; urethra; urinary incontinence

Indexed keywords

DIMETICONE; GLUTARALDEHYDE CROSS LINKED COLLAGEN; MACROPLASTIQUE; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BLADDER EMPTYING; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTALGIA; DRUG EFFICACY; DRUG SAFETY; DYSURIA; FEMALE; FOLLOW UP; HEADACHE; HEMATURIA; HUMAN; INJECTION SITE PAIN; KIDNEY INFECTION; MAJOR CLINICAL STUDY; MICTURITION; MULTICENTER STUDY; MYCOSIS; NAUSEA; NOCTURIA; OVERACTIVE BLADDER; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE BLIND PROCEDURE; STRESS INCONTINENCE; TREATMENT OUTCOME; URETHRA DISEASE; URGE INCONTINENCE; URINARY HESITANCY; URINARY TRACT INFECTION; URINARY URGENCY; URINE RETENTION;

BIOCOMPATIBLE MATERIALS; COLLAGEN; DIMETHYLPOLYSILOXANES; FEMALE; HUMANS; INJECTIONS; MIDDLE AGED; SINGLE-BLIND METHOD; URINARY INCONTINENCE, STRESS;

EID: 57149109555     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2008.09.032     Document Type: Article

References (20)

1. Fultz N.H., Burgio K., Diokno A.C., Kinchen K.S., Obenchain R., and Bump R.C. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol 189 (2003) 1275
2. Hannestad Y.S., Rortveit G., Sandvik H., and 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 53 (2000) 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.pdf Accessed September 22, 2008
4. ®) therapy for stress urinary incontinence in adult women. Eur Urol 44 (2003) 573
5. Harriss D.R., Iacovou J.W., and Lemberger R.J. Peri-urethral silicone microimplants (Macroplastique) for the treatment of genuine stress incontinence. Br J Urol 78 (1996) 722
6. Buckley J.F., Azmy A.A., Fyfe A.B., Scott R., Kirk D., Deane R.F., et al. Endoscopic correction of vesico-ureteric reflux with injectable silicone microparticles. J Urol, suppl. 149 (1993) 259A abstract 182
7. Tamanini J.T., D'Ancona C.A.L., Tadini V., and Netto Jr. N.R. Macroplastique implantation system for the treatment of female stress urinary incontinence. J Urol 169 (2003) 2229
8. Soliman S., and Evans C. Endoscopic Macroplastique injection for the treatment of female stress incontinence: role and efficacy. African J Urol 7 (2001) 45
9. Abrams P., Blaivas J.G., Stanton S.L., and Andersen J.T. The standardization of terminology of lower urinary tract function. International Continence Society Committee on Standardization of Terminology. Scand J Urol Nephrol, suppl. 114 (1988) 5
10. Bushnell D.M., Martin M.L., Summers K.H., Svihra J., Lionis C., and Patrick D.L. Quality of life of women with urinary incontinence: cross-cultural performance of 15 language versions of the I-QOL. Qual Life Res 14 (2005) 1901
11. Hwang I.K., and Morikawa T. Design issues in non-inferiority/equivalence trials. Drug Inform J 33 (1999) 1205
12. Kiilholma P., and Mäkinen J. Disappointing effect of endoscopic Teflon injection for female stress incontinence. Eur Urol 20 (1991) 197
13. Stenberg A., Larsson G., Johnson P., Heimer G., and Ulmsten U. DiHA Dextran Copolymer, a new biocompatible material for endoscopic treatment of stress incontinent women. Acta Obstet Gynecol Scand 78 (1999) 436
14. Lightner D., Calvosa C., Andersen R., Klimberg I., Brito C.G., 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 58 (2001) 12
15. Hurtado E., McCrery R., and 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 18 (2007) 869
16. Radley S.C., Chapple C.R., Mitsogiannis I.C., and Glass K.S. Transurethral implantation of Macroplastique for the treatment of female stress urinary incontinence secondary to intrinsic sphincter deficiency. Eur Urol 39 (2001) 383
17. Muller M., Koebele A., and Deval B. Determinants of success and recurrence after suburethral free tape procedure for female urinary incontinence. J Gynecol Obstet Biol Reprod 36 (2007) 19
18. Bullock T.L., Ghoniem G.M., Klutke C.G., and Staskin D.R. Advances in female stress urinary incontinence: mid-urethral slings. BJU Intl, suppl. 98 (2006) 32
19. Levin I., Groutz A., Gold R., Pauzner D., Lessing J.B., and Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn 23 (2004) 7
20. Bhargava S., and Chapple C.R. Rising awareness of the complications of synthetic slings. Curr Opin Urol 14 (2004) 317