A fully bioresorbable polycaprolactone-based bioresorbable bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence (SUI) who attempted and failed prior pelvic floor muscle training.

Forty-four adult female subjects with mild or moderate SUI (Median age 60 and 57 respectively) were treated by transurethral sub-mucosal injection. The procedure was performed in an out-patient setting using local infiltration anesthesia (lidocaine 1%). Over a period of 24 months safety was evaluated at 6-, 12- and 24-monts follow-up visits. Efficacy was assessed with the same intervals with the Stamey Grading System (SGS). Due to the retrospective nature of the study, participants were not subjected to any study treatments or actions. The medical information used was registered as the standard of care in the medical records of the patients.

Stamey Grading Score (SGS) improvement was shown in both the mild and moderate SUI groups. At 12 months, 96.9% of the patients with mild SUI were still continent (n=31) versus 100% of patients with moderate SUI (n=12). At 24 months, most participants continued to be continent; 78.1% in the mild SUI group (n=25) and 66.7% in the moderate SUI group (n=8). Moreover, all participants in the moderate SUI group showed an improvement of the SGS grade versus baseline. 
Adverse events were few and mild in nature consisting of 5 urinary tract infections that were treated by antibiotics (3 in the mild SUI group vs. 2 in the moderate SUI group). One case of urinary retention occurred in the mild SUI group which was resolved within 24h by simple temporary catheterization.

The aim of the study was to evaluate the long-term safety and efficacy results of a PCL-based bioresorbable urethral filler used for the treatment of mild to moderate female SUI treated in a single hospital by a single physician in an out-patient setting. The safety and efficacy results suggest that the treatment can be safely performed in an out-patient setting while showing long-term efficacy results. Due to the nature of the out-patient setting (short-stay), use of local infiltration anesthesia and the minimally-invasive nature of the procedure, it may also lower the burden on both the patient and the healthcare system, while leaving the option for surgical intervention open as a future option.

The study shows that the polycaprolactone-based bioresorbable bulking agent treatment seems to be a safe and effective treatment option for women with mild to moderate stress urinary incontinence who attempted and failed prior pelvic floor exercises.