An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

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 wit...

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Bibliographic Details
Published in:INTERNATIONAL UROGYNECOLOGY JOURNAL 2010-12, Vol.21 (12), p.1471-1477
Main Authors: Lose, Gunnar, Sørensen, Helle Christina, Axelsen, Susanne M., Falconer, Christian, Lobodasch, Kurt, Safwat, Tosson
Format: Article
Language:English
Subjects:
Acrylic Resins - adverse effects
Acrylic Resins - therapeutic use
Adult
Aged
Aged, 80 and over
Cohort Studies
Denmark
Female
Finland
Follow-Up Studies
Germany
Gynecology
Humans
Hydrogels - adverse effects
Hydrogels - therapeutic use
Medicin och hälsovetenskap
Medicine
Medicine & Public Health
Middle Aged
Original
Original Article
Sweden
Treatment Outcome
United Kingdom
Urinary Incontinence - therapy
Urinary Incontinence, Stress - therapy
Urology
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Summary: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.
ISSN:0937-3462
1433-3023
1433-3023
DOI:10.1007/s00192-010-1214-1