Background: The management of recurrent female stress urinary incontinence (SUI) still needs worldwide standardization. Few data on the role of urethral bulking agents (UBA) for the treatment of recurrent stress urinary incontinence exist. The aim of this study is to assess the efficacy and safety of urethral bulking agents for the treatment of recurrent SUI.
Methods: A multicenter, prospective study was conducted in four tertiary referral centers in two countries. All consecutive women with urodynamically-proven recurrent SUI, and with a history of previous failed anti-incontinence surgical procedure (mid-urethral sling or single incision sling), treated by UBAs were included. We evaluated only patients who completed at least a 3-year follow-up. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, Urogenital Distress Inventory score and patient satisfaction score), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable and multivariable analyses was performed to investigate outcomes.
Results: Forty-seven consecutive patients were enrolled. At 3-year follow-up, all women were available for the evaluation. At 3 years after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-year evaluation, 39 of 47 patients (83%) were objectively cured. Only five patients (10.6%) required re-operation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH<inf>2</inf>O (hazard ratio: 2.74; 95% CI, 1.64-10.7; P=0.009 and 1.62; 95% CI, 1.11-3.42; P=0.04, respectively) were the only predictors of failure. Only four complications were reported (8.5%).
Conclusions: The 3-year results of this study showed that bulking agents is an appropriately effective and safe option for the treatment of recurrent SUI. The presence of preoperative concomitant detrusor overactivity is associated with a significant decrease of the efficacy of this procedure.