title: An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev, Denmark. gulo@heh.regionh.dk
authors.forename: Gunnar
authors.initials: G
authors.lastname: Lose
authors.forename: Helle Christina
authors.initials: HC
authors.lastname: Sørensen
authors.forename: Susanne M
authors.initials: SM
authors.lastname: Axelsen
authors.forename: Christian
authors.initials: C
authors.lastname: Falconer
authors.forename: Kurt
authors.initials: K
authors.lastname: Lobodasch
authors.forename: Tosson
authors.initials: T
authors.lastname: Safwat
mesh_terms: 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*
chemical_list: D000180:Acrylic Resins; C528271:Bulkamid; D020100:Hydrogels; C016680:polyacrylamide gels