Urethral bulk injection therapy for female stress urinary incontinence A multiperspective evaluation

We evaluated the efficacy, safety and effect on sexual function of a relative new urethral bulking agent (polydimethylsiloxane Urolastic® (PDMS-U)) for female stress urinary incontinence (SUI) through a high power post-market clinical follow-up study and demonstrated the value of PDMS-U economically and from the patients’ perspective. Lastly, we analyzed to what extent the physicians learning-curve influenced safety outcomes. We showed that patients want to be informed about PDMS-U as primary treatment option for SUI. Next, we showed that when patients had to choose between bulk injection therapy and mid-urethral sling surgery (MUS-surgery) personal factors play also a role and not only efficacy and procedural factors. Some patients even preferred bulk injection therapy although it was associated with a lower cure rate. In a treatment trade-off model, however, we showed that the majority of patients are not willing to give up much efficacy (0-6%) to prefer bulk injection therapy over MUS-surgery. In our comparative two-armed cohort study we reported that the objective and subjective efficacy of PDMS-U at one year follow-up is lower than MUS-surgery. PDMS-U was associated with a 20% chance of excision of the bulk material. The sexual function after both MUS-surgery and PDMS-U equally improved. In a learning curve study we showed that the experience of the physician did not influence the chance of complications. The cost-effectiveness analysis showed that, depending on the outcome measure, MUS-surgery was the most cost-effective treatment option in improving disease specific QoL, whereas PDMS-U was more cost-effective in improving generic quality of life.