An open, multicentre study of NASHA/Dx gel (Zuidex™) for the treatment of stress urinary incontinence

Objective: The Zuidex (TM) system facilitates non-endoscopic urethral injection for stress urinary incontinence (SUI). It comprises four pre-filled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and an Implacer (TM) device. This open, 12-month study was performed to evaluate the safety and efficacy of this system in women with SUI. Methods: Patients were aged >= 18 years with a history of SUI for >= 12 months (hypermobility and/or intrinsic sphincter deficiency), had failed prior non-invasive therapy and were invasive-therapy naive. Up to two treatments with NASHA/Dx gel were permissible (re-treatment was offered at week 8). Positive response to treatment was defined as a reduction in provocation test leakage of >= 50% compared with baseline. Efficacy was also measured by 24-hour pad weight test leakage, and number of incontinence episodes/24 hours. Results: A total of 142 patients were enrolled, with a mean age of 55.7 years. The response rate was 78% at week 12, and 77% at month 12. Significant reductions in median provocation test leakage, 24-hour pad-weight test leakage and number of incontinence episodes/24 hours were observed at all time-points. At month 12, the median decreases from baseline in these three variables were 93%, 89% and 67%, respectively. Treatment-related adverse events were of a nature expected with urethral injection - most were transient, and of mild or moderate intensity. Conclusions: Treatment with NASHA/Dx gel produced large, statistically significant reductions in urinary leakage sustained over 12 months and was well tolerated. These findings suggest that NASHA/Dx gel could be considered as an early intervention in treatment-naive cases of SUI. (c) 2005 Elsevier B.V. All rights reserved.