Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid(®)) in the management of stress and mixed urinary incontinence: three year follow up outcomes

Cent European J Urol. 2015;68(4):428-33. doi: 10.5173/ceju.2015.647. Epub 2015 Nov 13.

Abstract

Introduction: There are a myriad of treatment options available for patients suffering with the increasingly prevalent condition of stress urinary incontinence (SUI). The minimally invasive nature of periurethral bulking agents makes them an attractive proposition in the correctly selected patient. There is, however, limited data available on the medium to long term safety and efficacy of this procedure. The aim of our study is to evaluate the outcomes of Polyacrylamide Hydrogel (PAHG) (Bulkamid(®)) as a periurethral bulking agent at our institution.

Material and methods: From 2006 to 2011, two hundred and fifty six women underwent periurethral bulking with PAHG in the management of SUI or mixed urinary incontinence (MUI). Women were assessed with at least yearly quality of life and ICIQ questionnaires.

Results: The majority of patients had the procedure under a local anaesthetic, with a median operative time of 9 minutes. Median follow up was 38 months. 82% of patients reported cure/significant improvement at 3 months. Importantly, this high satisfaction rate was maintained at final follow up and was reflected in both VAS and ICIQ scores. There were no reported adverse reactions and no significant safety concerns.

Conclusions: We conclude that Bulkamid(®) injection is an efficacious, minimally invasive, and safe procedure for a selected group of patients with stress incontinence. In our study, PAHG has been shown to be durable and safe.

Keywords: Bulkamid®; polyacrylamide hydrogel; stress urinary incontinence; trans-urethral injection.