Current urology · 2026
Efficacy of early intravesical instillation of hyaluronic acid after transurethral resection of non-muscle-invasive bladder cancers: An open-label, prospective, single-center, randomized, controlled and parallel-group pilot study.
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Casale Paolo, Hurle Rodolfo, Buffi Nicolò M, Lughezzani Giovanni, Saita Alberto, Fasulo Vittorio, Paciotti Marco, Benetti Alessio, Peschechera Roberto, Pasini Luisa, Zandegiacomo Silvia, Arena Paola, Uleri Alessandro, Lazzeri Massimo
Аннотация
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 efficacy 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 HydealCyst (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 HydealCyst. The efficacy of HydealCyst 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 HydealCyst. These patients also showed a significant 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 HydealCyst, supporting this intervention as a potentially effective treatment for LUTS and pain after TURBT.
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 HydealCyst. The efficacy of HydealCyst 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 HydealCyst. These patients also showed a significant 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 HydealCyst, supporting this intervention as a potentially effective treatment for LUTS and pain after TURBT.