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An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence
Gunnar Lose1, Helle Christina Sørensen, Susanne M Axelsen
1Department of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev, Denmark. gulo@heh.regionh.dk
Introduction:
Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.
Methods:
Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%).
Results:
At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen.
Conclusions:
Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.
