Randomized Controlled Multisite Trial of Injected Bulking Agents for Women With Intrinsic Sphincter Deficiency: Mid-urethral Injection of Zuidex Via the Implacer Versus Proximal Urethral Injection of Contigen Cystoscopically - 06/08/11
, Eric Rovner b, Jacques Corcos c, Christopher Payne d, Linda Brubaker e, Harold Drutz f, Gary Steinhoff gZuidex Study Group
Reprint requests: Deborah J. Lightner, M.D., Mayo Clinic, 200 First Street, SW, Rochester, MN 55905Résumé |
Objectives |
To determine whether Zuidex using a non-cystoscopy mid-urethral injection technique produces as good a result (i.e. was not inferior) as Contigen injected endoscopically at the bladder neck in the treatment of urinary stress incontinence secondary to intrinsic sphincter deficiency in adult women.
Methods |
A prospective 2:1 randomized trial of mid-urethral injections of Zuidex-Implacer vs proximal urethral cystoscopic injections of Contigen was performed in 344 women with intrinsic sphincter deficiency at 23 North American sites, and followed up for >1 year from last treatment.
Results |
Outcomes at 12 months from last treatment failed to demonstrate that mid-urethral injected Zuidex was equivalent to cystoscopically injected Contigen in primary and secondary outcome variables. The primary outcome, the proportion of women who achieved a 50% reduction in urinary leakage on provocation testing, was achieved in 84% of Contigen-treated women vs 65% of Zuidex-treated women.
Conclusions |
Confounding multiple variables inherent in the study design make a detailed analysis of study outcomes difficult.
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| This study was sponsored and supported by Q-Med AB, Inc., Uppsala, Sweden. |
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| Zuidex Study Group: Rodney Appell, MD, Baylor College of Medicine, Houston, TX; Stanley H. Galansky, MD, Urology Associates, Denver, Colorado; Gamal Ghoniem, MD, Cleveland Clinic, Florida, Weston, Florida; G. Willy Davila, MD, Cleveland Clinic, Weston, Westin, FL; Sender Herschorn, MD, Sunnybrook and Women's College, Toronto, Canada; Saad Juma, MD, Incontinence Research Institute, Encinitas, CA; Jeffrey L. Cornella, MD, Mayo Clinic, Arizona, Phoenix, Arizona; Steven P. Petrou, MD, Mayo Clinic, Jacksonville, Jacksonville, FL; M. Louis Moy, MD, University of Pennsylvania, Philadelphia, PA; Arthur Tarantino, MD, Connecticut Surgical Group, Hartford, CT; J. Christian Winters, MD, Ochsner Urology Institute, New Orleans, LA; Karny Jacoby, MD, Urology North-West, Seattle, WA; David J. Vaughan, Jr, MD, Winter Park Urology Associates, Orlando, FL; Norris Whitlock, MD, Whitlock and Devore Urology Group, Greer, South Carolina; R. Douglas Devore, MD, Whitlock and Devore Urology Group, Greer, South Carolina; Rafael Wurzel, MD, Grove Hill Medical Center, New Britain, Connecticut; Alfred E. Bent, MD, Greater Baltimore Medical Center, Baltimore, MD; Roger Dmochowski, MD, Vanderbilt University School of Medicine, Nashville, TN; Linda Dalin, MSc, Statistician, Q-Med AB, Uppsala, Sweden. |
Vol 74 - N° 4
P. 771-775 - octobre 2009 Retour au numéro
Article précédent
- Ineffectiveness of Associating a Suburethral Tape to a Transobturator Mesh for Cystocele Correction on Concomitant Stress Urinary Incontinence
- Fabrice Sergent, Gaëlle Gay-Crosier, Violène Bisson, Benoît Resch, Eric Verspyck, Loïc Marpeau
- Editorial Comment
- David A. Ginsberg
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