Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

INTRODUCTION AND HYPOTHESIS: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence. METHODS: Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24 months postinjection. RESULTS: At 24 months, the subjective responder rate was 64 % (a statistically non-significant reduction from 67 % at 12 months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred. CONCLUSIONS: PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.