Efficacy and safety of a novel system (NASHA/Dx copolymer using the Implacer device) for treatment of stress urinary incontinence.

OBJECTIVES: To investigate the efficacy and safety of non-animal-stabilized hyaluronic acid/dextranomer (NASHA/Dx) copolymer for transurethral injection using a new guiding instrument (the Implacer) for stress urinary incontinence.

METHODS: In an open, prospective, multicenter study, 42 invasive therapy-naive female patients with stress urinary incontinence were given 4 x 1.0 mL or 4 x 0.7 mL of NASHA/Dx copolymer using the Implacer. The efficacy parameters, measured at baseline and 1, 3, 6, and 12 months after treatment, included cough-induced leak point pressure, urine leakage by provocation test, number of incontinence episodes in 24 hours, and patient perception of bladder condition, rated on a 6-point scale.

RESULTS: The collected cough-induced leak point pressure data were not judged to be valid and reliable. Statistically significant reductions in median urine leakage were observed (P <0.0001), from 36 g (range 0.0-300) after 20 "jumping jacks" or vigorous coughs at baseline to 5.5 g (range 0.0-98) at 3 months and sustained at 12 months (7.0 g, range 0.0-98). Of the 42 patients, 32 (76%) demonstrated a degree of improvement in urine leakage at 3 and 12 months. The median number of incontinence episodes in 24 hours decreased significantly from 1.9 (range 0.0-24) at baseline to 0.4 (range 0.0-24) at 12 months (P <0.0001). At both 3 and 12 months, 29 patients (69%) had improved by at least one category on the 6-point patient perception scale. Treatment was well tolerated, and no complications were reported with use of the Implacer.

CONCLUSIONS: The results of this study indicate that a novel system (NASHA/Dx copolymer insertion using the Implacer) is an effective and well-tolerated treatment for invasive therapy-naive patients with stress urinary incontinence, with improvement sustained for at least 12 months. These encouraging results warrant additional study.