Deflux® (NASHATM/Dx) urethral bulking injections: Outcomes over a decade in women with stress urinary incontinence

Abstract

Objectives: Urethral bulking injections are thought to be a low risk minimally invasive but temporary treatment option for women with stress urinary incontinence (SUI) with increasing prominence especially in the current era of the mesh controversy. However, little is known about their long-term effects. This study aims to evaluate the efficacy and long-term outcomes of Deflux®, a non-animal stabilised hyaluronic acid/dextranomer (NASHATM/Dx) gel, when used as a urethral bulking agent in the treatment of SUI in women. Methods: All women with SUI treated with Deflux® from 2001 to 2007 were analysed. The success rates, duration of efficacy and short- and long-term complications of the treatment were recorded. Results: A total of 142 women with a follow-up of up to 13 years (mean 8.8 years) were included. Subjective treatment success was achieved in 92/142 (65%) patients. In those who achieved continence, the mean efficacy was 4.7 years. Side effects were uncommon with 12 (6%) of 209 experiencing transient urinary retention and 11 (5%) of 209 experiencing pseudocyst formation. All pseudocysts were treated successfully with an incision and drainage under either general or local anaesthetic. Sixty (42%) of 142 patients went on to have subsequent definitive incontinence surgery, and Deflux® treatment was found not to have negatively impacted the operation. Conclusion: Deflux® urethral bulking injections appear to be efficacious and safe when used as a treatment for SUI in women with a longer duration of efficacy than previously thought and a low side effect profile. This study provides a valuable timeline to help manage the expectations of patients considering urethral bulking treatment. Level of evidence: 4