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.
European urology open science. 2026 Apr 01*** epublish ***
Francesco Callegarin, Antonio Amodeo, Francesco Claps, Alessandro Crestani, Alessandro Antonelli, Gian Maria Busetto, Fabrizio Dal Moro, Nicola Zanovello, Nicola Pavan, Giovanna Magni, Ilaria Buran, Luca Di Gianfrancesco, Gian Luca De Salvo, Angelo Porreca
Clinical Research Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy., Oncological Urology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy., Department of Urology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy., Department of Urology, University of Verona, Verona, Italy., Department of Medical and Surgical Sciences, Ospedale Riuniti, University of Foggia, Foggia, Italy., Urology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy., Urology Unit, Madre Teresa di Calcutta Hospital, AULSS 6, Ospedali Riuniti Padova Sud, Monselice, Italy., Urology Clinic, Department of Precision Medicine in Medical, Surgical and Critical Care, University of Palermo, Palermo, Italy., Department of Urology, Humanitas Gavazzeni Hospital, Bergamo, Italy.