The use of a polycaprolactone based bulking agent for the treatment of female stress urinary incontinence (SUI); a pivotal trial.
In summary, the 12-month intermediate analysis shows Urolon™ as a safe and effective treatment option for woman with mild to moderate SUI who have attempted or failed pelvic floor muscle training. Results show improvements in SUI severity and QoL (see figure 1-3) with only few mild treatment-related AE’s which supports a high safety profile. The clinical study sites expressed their high satisfaction with the performance of Urolon™. The bioresorption profile of Urolon™ is an attractive characteristic and feedback from urologists, gynecologists and urogynecologists alike, suggest this is a highly sought-after feature of a UBA. As the study is ongoing additional data will be provided at 18- and 24-month follow-up to further confirm the safety and efficacy profile of Urolon™.
12 Month Follow-up
AQLANE Medical™ is pleased to announce that our 6-month clinical data abstract has been accepted for Poster Presentation at the ICS 2018 Meeting 28-31 August in Philadelphia, USA.
Concluding message: QoL measures are an essential end-point for measuring patients perceptions of the effects of incontinence treatments. Improvements in QoL shown here further demonstrate the efficacy of this PCL-based bulking agent. In addition to its efficacy, bioresorption is an attractive safety feature of the PCL-based bulking agent when compared to permanent materials. Preliminary results suggest that the bioresorbable PCL-based bulking agent is a promising safe and effective treatment option, and a valuable addition to the current treatment armament for female patients with mild to moderate SUI, who attempted and failed prior pelvic floor muscle training.
AQLANE Medical™ is pleased to announce that abstract entitled “Treatment with a polycaprolactone-based bioresorbable collagen stimulator (BCS) for mild to moderate SUI” showcasing interim data from our European pivotal trial was accepted for a poster presentation by the EUGA Scientific Committee.
AQLANE Medical™ is pleased to announce that patient enrollment is completed and all subjects are treated in their multicenter European clinical trial entitled “The use of a Polycaprolactone Based Bulking Agent for the Treatment of Female Stress Urinary Incontinence (SUI), a Pivotal Trial”.
AQLANE Medical™ is pleased to announce the first patient has been enrolled and treated in their multicenter clinical trial entitled “The use of a Polycaprolactone Based Bulking Agent for the Treatment of Female Stress Urinary Incontinence (SUI), a Pivotal Trial”.
AQLANE Medical™ received approval to start their multicenter clinical trial in the Netherlands. Following the University Hospital in Antwerp (UZA), Belgium, two Dutch sites will start patient enrollment; the Catharina Hospital in Eindhoven and the Laurentius Hospital in Roermond.
The clinical trial is registered in the Dutch Trial Register (NTR) under number 6002, please click here to read the trial info.
AQLANE Medical™ received approval to start their multicenter clinical trial in Belgium. The University Hospital in Antwerp (UZA) is the first hospital to enroll patients into this 2-year study.
AQLANE Medical™ initiated a prospective, pivotal trial to study the safety and efficacy of Urolon™, our PCL-based bulking agent for female stress urinary incontinence (SUI). Site selection is completed and patient enrollment is underway.