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

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: = 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.