An open, multicentre study of NASHA/Dx Gel (Zuidex) for the treatment of stress urinary incontinence.
OBJECTIVE
The Zuidex 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 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 > or =18 years with a history of SUI for > or =12 months (hypermobility and/or intrinsic sphincter deficiency), had failed prior non-invasive therapy and were invasive-therapy naïve. 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 > or =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-naïve cases of SUI.
Chapple
Christopher R
CR
Sheffield Teaching Hospitals NHS Trust, Urology Research, Royal Hallamshire Hospital, South Yorkshire, UK. c.r.chapple@sheffield.ac.uk
Haab
François
F
Cervigni
Mauro
M
Dannecker
Christian
C
Fianu-Jonasson
Aino
A
Sultan
Abdul H
AH
D000328:Adult; D001672:Biocompatible Materials / Q000008:administration & dosage; D003911:Dextrans / Q000008:administration & dosage*; D004337:Drug Carriers; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007267:Injections / Q000295:instrumentation*; D008863:Microspheres; D011788:Quality of Life; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014521:Urethra; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
D001672:Biocompatible Materials; D003911:Dextrans; D004337:Drug Carriers; D005782:Gels; C496587:NASHA-Dx copolymer; D006820:Hyaluronic Acid