Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence

Neurourol Urodyn. 2021 Jan;40(1):502-508. doi: 10.1002/nau.24589. Epub 2021 Jan 7.

Abstract

Aims: Bulking agents are a minimally invasive treatment option for women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). The aim of this study was to evaluate long-term efficacy and safety following treatment with Bulkamid as a primary procedure for SUI or stress-predominant MUI.

Methods: This was an Institutional Review Board-approved single-center retrospective study of female patients with SUI or stress-predominant MUI who had undergone injection with Bulkamid since 2005 and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four-point scale as cured, improved, unchanged, or worse. Secondary outcomes included the number of incontinence pads used, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF) scores, Visual Analog Scale Quality of Life (VAS QoL), reinjection rates, and perioperative and postoperative complications.

Results: A total of 1,200 patients were treated with Bulkamid since 2005 and of these, 388 (32.3%) had completed 7 years of follow-up. A total of 67.1% of the patients reported feeling cured or improved if Bulkamid was a primary procedure, 11.1% reported no change, and 2.3% reported worsening of incontinence. A total of 19.5% of patients received a subsequent other incontinence procedure. The ICIQ-UI SF was reduced by 8.6 points. VAS QoL improved by a mean of 4.3 points. Postoperative complications were transient. Prolonged bladder emptying time was reported in 15.3% of patients and urinary tract infection in 3.5%.

Conclusions: Bulkamid injections are an effective and safe first-line treatment option for women with SUI or stress-predominant MUI providing durable outcomes at 7 years.

Keywords: Bulkamid; bulking agents; long-term follow-up; mixed urinary incontinence; stress urinary incontinence.

MeSH terms

  • Acrylic Resins / pharmacology
  • Acrylic Resins / therapeutic use*
  • Aged
  • Biocompatible Materials / pharmacology
  • Biocompatible Materials / therapeutic use*
  • Female
  • Humans
  • Hydrogels / pharmacology
  • Hydrogels / therapeutic use*
  • Male
  • Treatment Outcome
  • Urinary Incontinence, Stress / drug therapy*

Substances

  • Acrylic Resins
  • Biocompatible Materials
  • Bulkamid
  • Hydrogels