Two-year Follow-Up of an Open-Label Multicenter Study of Polyacrylamide Hydrogel (Bulkamid®) for Female Stress and Stress-Predominant Mixed Incontinence

Int Urogynecol J. 2012 Oct;23(10):1373-8. doi: 10.1007/s00192-012-1761-8. Epub 2012 Apr 25.

Abstract

Introduction and hypothesis: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence.

Methods: Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24 months postinjection.

Results: At 24 months, the subjective responder rate was 64 % (a statistically non-significant reduction from 67 % at 12 months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred.

Conclusions: PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.

Publication types

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

MeSH terms

  • Acrylic Resins / administration & dosage
  • Acrylic Resins / adverse effects*
  • Acrylic Resins / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Humans
  • Hydrogels / administration & dosage
  • Hydrogels / adverse effects*
  • Hydrogels / therapeutic use*
  • Injections
  • Longitudinal Studies
  • Middle Aged
  • Prevalence
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome
  • Urinary Incontinence, Stress / classification*
  • Urinary Incontinence, Stress / drug therapy*
  • Urinary Incontinence, Stress / epidemiology

Substances

  • Acrylic Resins
  • Bulkamid
  • Hydrogels
  • polyacrylamide gels