Background:Lower urinary tract symptoms(LUTS)and pain are clinically relevant problems after transurethral resection(TURBT)of nonmuscle-invasive bladder cancer.Although intravesical instillation of hyaluronic acid has...Background:Lower urinary tract symptoms(LUTS)and pain are clinically relevant problems after transurethral resection(TURBT)of nonmuscle-invasive bladder cancer.Although intravesical instillation of hyaluronic acid has already been proven to be a valid treatment for storage LUTS and pain in patients with inflammatory bladder syndrome,its effcacy in patients who undergo TURBT is unknown.This study aimed to present the results of a prospective,randomized,controlled,clinical pilot study on the safety and clinical performance of Hydeal Cyst(Fidia Farmaceutici S.p.A.,Italy),a device formulated to provide progressive,long-lasting intravesical release of hyaluronic acid.Materials and methods:Adults diagnosed with nonmuscle-invasive bladder cancer and scheduled for TURBT were included and underwent 4 visits up to 25 days after TURBT.Of the 47 patients who completed the investigation,25 participants received 2 postoperative intravesical instillations with Hydeal Cyst.The effcacy of Hydeal Cyst on storage LUTS,pain,urinary symptoms,and patients'quality of life was evaluated using validated questionnaires.Results:Although the overall LUTS were similar in the 2 experimental groups,lower micturition frequency and fewer daytime micturitions were observed in patients treated with Hydeal Cyst.These patients also showed a signifcant reduction in pain(p=0.03)3 days after catheter removal and better quality of life at the end of the study.The device was well tolerated,with no treatment-emergent adverse events of severe intensity.Conclusion:The results from this pilot study indicate a clinically meaningful improvement of symptoms after 2 instillations of Hydeal Cyst,supporting this intervention as a potentially effective treatment for LUTS and pain after TURBT.展开更多
文摘Background:Lower urinary tract symptoms(LUTS)and pain are clinically relevant problems after transurethral resection(TURBT)of nonmuscle-invasive bladder cancer.Although intravesical instillation of hyaluronic acid has already been proven to be a valid treatment for storage LUTS and pain in patients with inflammatory bladder syndrome,its effcacy in patients who undergo TURBT is unknown.This study aimed to present the results of a prospective,randomized,controlled,clinical pilot study on the safety and clinical performance of Hydeal Cyst(Fidia Farmaceutici S.p.A.,Italy),a device formulated to provide progressive,long-lasting intravesical release of hyaluronic acid.Materials and methods:Adults diagnosed with nonmuscle-invasive bladder cancer and scheduled for TURBT were included and underwent 4 visits up to 25 days after TURBT.Of the 47 patients who completed the investigation,25 participants received 2 postoperative intravesical instillations with Hydeal Cyst.The effcacy of Hydeal Cyst on storage LUTS,pain,urinary symptoms,and patients'quality of life was evaluated using validated questionnaires.Results:Although the overall LUTS were similar in the 2 experimental groups,lower micturition frequency and fewer daytime micturitions were observed in patients treated with Hydeal Cyst.These patients also showed a signifcant reduction in pain(p=0.03)3 days after catheter removal and better quality of life at the end of the study.The device was well tolerated,with no treatment-emergent adverse events of severe intensity.Conclusion:The results from this pilot study indicate a clinically meaningful improvement of symptoms after 2 instillations of Hydeal Cyst,supporting this intervention as a potentially effective treatment for LUTS and pain after TURBT.
