Maurizio Serati1, Alessandro Giammò2, Roberto Carone2, Enrico Ammirati2, Marilena Gubbiotti3,4, Alessandro Ruffolo5, Stefano Salvatore5, Chiara Scancarello1, Fabiana Castronovo6, Giorgio Caccia6, Andrea Braga7,8. 1. Department of Obstetrics and Gynecology, Del Ponte Hospital, University of Insubria, Varese, Italy. 2. Department of Neuro-Urology, CTO/Unipolar Spinal Cord Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy. 3. Department of Urology, San Donato Hospital, Arezzo, Italy. 4. Serafico Institute of Assisi, Research Centre "InVita", Assisi, Perugia, Italy. 5. Department of Obstetrics and Gynecology, IRCSS San Raffaele Scientific Institute, Milan, Italy. 6. Department of Obstetrics and Gynecology, EOC - Beata Vergine Hospital, Mendrisio, Switzerland. 7. Department of Obstetrics and Gynecology, EOC - Beata Vergine Hospital, Mendrisio, Switzerland - andrea.braga@eoc.ch. 8. Faculty of biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.
Abstract
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 3yr 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-yr follow-up, all women were available for the evaluation. At 3 yr after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-yr evaluation, 39 of 47 patients (83%) were objectively cured. Only 5 patients (10.6 %) required reoperation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH2O (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-yr 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.
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 3yr 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-yr follow-up, all women were available for the evaluation. At 3 yr after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-yr evaluation, 39 of 47 patients (83%) were objectively cured. Only 5 patients (10.6 %) required reoperation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH2O (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-yr 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.