Effectiveness and Safety Profile of Urethral Bulking with Bulkamid® for Stress Urinary Incontinence: A French Multi-Center Cohort Study.

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.