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.

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.

• Authors: Deborah Lightner, Eric Rovner, Jacques Corcos, Christopher Payne, Linda Brubaker, Harold Drutz, Gary Steinhoff, Zuidex Study Group
• Journal: Urology (Urology) Vol. 74 Issue 4 Pg. 771-5 (Oct 2009) ISSN: 1527-9995 [Electronic] United States
• PMID: 19660800 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biocompatible Materials
• Dextrans
• dextranomer-hyaluronic acid copolymer
• glutaraldehyde-cross-linked collagen
• Hyaluronic Acid
• Collagen

Topics

• Biocompatible Materials (administration & dosage)
• Collagen (administration & dosage)
• Cystoscopy
• Dextrans (administration & dosage)
• Female
• Humans
• Hyaluronic Acid (administration & dosage)
• Injections
• Middle Aged
• Prospective Studies
• Urethra
• Urinary Incontinence, Stress (therapy)