Abstract：
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.
journal_name
Urologyjournal_title
Urologyauthors
Lightner D,Rovner E,Corcos J,Payne C,Brubaker L,Drutz H,Steinhoff G,Zuidex Study Group.doi
10.1016/j.urology.2009.05.034subject
Has Abstractpub_date
2009-10-01 00:00:00pages
771-5issue
4eissn
0090-4295issn
1527-9995pii
S0090-4295(09)00692-Xjournal_volume
74pub_type
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