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.
OBJECTIVE
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.
Lightner
Deborah
D
Mayo Clinic, 200 First Street, SW, Rochester, MN 55905, USA. lightner.deborah@mayo.edu
Rovner
Eric
E
Corcos
Jacques
J
Payne
Christopher
C
Brubaker
Linda
L
Drutz
Harold
H
Steinhoff
Gary
G
D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D003558:Cystoscopy; D003911:Dextrans / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007267:Injections; D008875:Middle Aged; D011446:Prospective Studies; D014521:Urethra; D014550:Urinary Incontinence, Stress / Q000628:therapy*
D001672:Biocompatible Materials; D003911:Dextrans; C487487:dextranomer-hyaluronic acid copolymer; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen