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  • Cystoscopic injections of dextranomer hyaluronic acid into proximal urethra for urethral incompetence: efficacy and adverse outcomes.

Cystoscopic injections of dextranomer hyaluronic acid into proximal urethra for urethral incompetence: efficacy and adverse outcomes.

Urology (2010-03-20)
Deborah J Lightner, Janelle Fox, Christopher Klingele
ABSTRACT

To determine whether dextranomer/hyaluronic acid would be more efficacious or would produce fewer complications when using the material in a standard proximal-urethra cystoscopically-directed injection technique. Injectable periurethral bulking agents are an alternative to stress incontinence surgery. Dextranomer, a highly hydrophilic dextran polymer, solubilized in a base of nonanimal stabilized hyaluronic acid, has been approved as an injectable agent for the treatment of childhood vesicoureteric reflux (Deflux, Q-Med AB, Uppsala, Sweden), and in Europe for women with stress urinary incontinence (SUI) (Zuidex, Q-Med AB, Uppsala, Sweden). A previous multicenter trial demonstrated nonequivalence compared with bovine glutaraldehyde cross-linked collagen with a high complication rate. We sought to determine whether the failure of the treatment lay in the material itself or the use of a blind, midurethral injection technique. A retrospective case series of 56 patients undergoing cystoscopically guided bladder neck injections of dextranomer/hyaluronic acid with follow-up in 42, included 35 women with intrinsic sphincter deficiency (ISD), 4 men with postprostatectomy incontinence, 2 men with sphincteric denervation secondary to spinal cord injury, and 1 woman with sphincteric failure after a neobladder. Outcome assessment used gender-appropriate International Consultation on Incontinence Questionnaire, clinical records, and/or urodynamic assessment. Of 35 women with ISD, 4 developed pseudoabscess formation with outlet obstruction requiring multiple operative interventions. Patient-defined treatment failure occurred in all 4 carefully selected postprostatectomy incontinent men, and in 23 of 35 females with ISD. Complications with cystoscopically injected dextranomer hyaluronic acid at the bladder neck occurred at a high rate, and using a validated questionnaire, the efficacy of dextranomer hyaluronic acid applied in this manner for ISD was poor.

MATERIALS
Product Number
Brand
Product Description

Dextranomer, European Pharmacopoeia (EP) Reference Standard