Introduction and hypothesis: Various treatment options are currently available for the management of stress urinary incontinence (SUI). This study was aimed at determining the effectiveness and safety profile of Bulkamid®, and identify predictive factors of clinical success.
Methods: This retrospective study conducted in two French urogynecology university centers between September 2019 and December 2023 included all patients with urinary incontinence who received Bulkamid®.
Results: Among the 320 patients included (median age 58.2 years), the median follow-up was 24 months. Urethral hypermobility was found in 93.4% of patients (n = 282) and 92% (n = 275) had a positive cough test. At 1 month, 68.7% of patients (n = 220) achieved clinical success, 25.6% (n = 82) improved, and 5.6% (n = 18) reported failure. At last follow-up, 63.7% of patients (n = 204) were still cured, 21.9% (n = 70) had improved, and 14.4% (n = 46) reported failure. Among the 16 patients with overactive bladder (OAB) 43.7% had a Patient Global Improvement (PGI) score of 1-2 at 1 month and 50.0% at last follow-up, with significant difference compared with patients without OAB, 81.0% had a PGI score of 1-2 at 1 month and 74.8% at last follow-up (p = 0.0006 and p = 0.04 respectively). Regarding complications, acute urinary retention occurred in 3.1% of patients (n = 10), urinary infections in 2.2% (n = 7), and transient hematuria in 7.2% (n = 23). In multivariate analysis, follow-up time was significantly associated with failure compared with improvement/cure (OR = 1.05, 95% CI 1.02-1.08, p = 0.0002).
Conclusion: The present large series of patients reported the effectiveness of Bulkamid® injection, a minimally invasive procedure providing good clinical outcomes at 2 years' follow-up.
Keywords: Intrinsic sphincter deficiency; Mid-urethral sling; Polyacrylamide hydrogel; Stress urinary incontinence; Treatment preference; Urethral bulking agent.
© 2024. The International Urogynecological Association.