An Open Multicenter Study of Polyacrylamide Hydrogel (Bulkamid®) for Female Stress and Mixed Urinary Incontinence

Int Urogynecol J. 2010 Dec;21(12):1471-7. doi: 10.1007/s00192-010-1214-1. Epub 2010 Jul 20.

Abstract

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acrylic Resins / adverse effects
  • Acrylic Resins / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Cohort Studies
  • Denmark
  • Female
  • Finland
  • Follow-Up Studies
  • Germany
  • Humans
  • Hydrogels / adverse effects
  • Hydrogels / therapeutic use*
  • Middle Aged
  • Sweden
  • Treatment Outcome
  • United Kingdom
  • Urinary Incontinence / therapy*
  • Urinary Incontinence, Stress / therapy*

Substances

  • Acrylic Resins
  • Bulkamid
  • Hydrogels
  • polyacrylamide gels