An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.
BACKGROUND
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.
Lose
Gunnar
G
Department of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev, Denmark. gulo@heh.regionh.dk
Sørensen
Helle Christina
HC
Axelsen
Susanne M
SM
Falconer
Christian
C
Lobodasch
Kurt
K
Safwat
Tosson
T
D000180:Acrylic Resins / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D003718:Denmark; D005260:Female; D005387:Finland; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D020100:Hydrogels / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013548:Sweden; D016896:Treatment Outcome; D006113:United Kingdom; D014549:Urinary Incontinence / Q000628:therapy*; D014550:Urinary Incontinence, Stress / Q000628:therapy*
D000180:Acrylic Resins; C528271:Bulkamid; D020100:Hydrogels; C016680:polyacrylamide gels