A Study to Evaluate Efficacy and Safety of Hydeal Cyst Intravesical Instillations in Non–muscle Invasive Bladder Cancer Patients Treated With Intravesical Chemotherapy or Immunotherapy

In non-muscle-invasive bladder cancer (NMIBC), patients undergo adjuvant local therapies such as chemotherapy (mitomycin C [MMC]) or immunotherapy (Bacillus Calmette-Guérin [BCG]) to reduce the risk of relapse and local/systemic progression. The main issue related to these topic therapies is their toxicity that is mainly local with rare systemic events. Hyaluronic acid is recommended in cases where it is necessary to restore and/or protect the layer of glycosaminoglycans damaged by local therapies. The Hydeal Cyst (HC) trial is a multicenter, randomized, controlled, open-label clinical investigation that aims to evaluate if HC intravesical instillations could mitigate lower urinary tract symptoms (LUTS) and improve oncological outcomes. Overall, 200 patients affected by NMIBC (naïve or recurrent) underwent transurethral resection (TURB/re-TURB when indicated) in the 4 wk before enrolment, and candidates to BCG or MMC intravesical induction therapy with an International Prostrate Symptom Score ≤10 will be randomized to HC intravesical instillations or control. The primary objective is to investigate if multiple HC intravesical instillations decrease the LUTS. Secondary objectives are recurrence-free survival, progression-free survival, safety, and quality of life. This study has potential to change the current LUTS treatment approaches, reducing the rate of early treatment discontinuation and thereby leading to a higher rate of therapeutic response.