DUGi

Office fulguration versus conventional turbt in the management of recurrences and impact in quality of life in nonmuscle invasive bladder cancer of intermediate risk: a prospective randomized clinical trial

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Background: According to statistics bladder cancer has an incidence of 6–8 cases per 100,000 inhabitants, with about 500 new diagnoses annually in Catalonia. Most cases are non–muscle-invasive (NMIBC). Although prognosis is generally good, recurrences are frequent in intermediate-risk patients (30–50% within five years), representing a major challenge due to repeated procedures, patient discomfort, and healthcare costs. The standard treatment for recurrences, transurethral resection of the bladder tumor (TURBT), is effective but invasive, requiring anesthesia and operating room use. Office fulguration (OF), performed under flexible cystoscopy, has recently emerged as a less invasive alternative. Early evidence indicates good safety, tolerability, and patient acceptance, though data remain limited, particularly in intermediate-risk NMIBC where optimized management is most needed. Objectives: The primary objective of this study is to evaluate the efficacy and safety of OF compared with conventional TURBT measuring the number of recurrences in patients with IR-NMIBC. Secondary objectives of the project include to measure the time until the recurrence, evaluating patient-reported quality of life (QoL) and adverse events related of each procedure. Design: This is a multicentric prospective non-inferiority open-label randomized clinical trial, aiming to evaluate the outcomes of patients with IR-NMIBC recurrence who undergo OF compared with those treated with TURBT. Participants and methods: Non-anticoagulated patients with IR-NMIBC (TaLG recurrence or multiple TaLG) will be randomized in a 1:1 ratio to undergo either OF or TURBT

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