Bladder cancer is the most common malignancy of the urinary tract, and approximately 75% of cases are non-muscle invasive (NMIBC) at diagnosis. The standard treatment is transurethral resection of the bladder tumor (TURBT). En bloc resection (EBR-T), in which the tumor is removed in one intact piece rather than fragmented, offers superior pathological specimen quality and may reduce the need for repeat resections. However, extracting the intact specimen from the bladder through the urethra remains a critical technical challenge, particularly for larger tumors.
CURTIS (Urotech GmbH) is a CE-marked retrieval device consisting of a hydrophilic-coated bag that can be opened and closed via a handpiece, enabling controlled capture and safe transurethral extraction of the resected tumor specimen.
This study aims to evaluate the technical feasibility of CURTIS-assisted intact specimen retrieval following en bloc transurethral resection of primary NMIBC. The central question the study seeks to answer is: in what proportion of cases can CURTIS successfully retrieve an intact en bloc resected bladder tumor, and what is the maximum tumor size for which intact retrieval remains feasible?
Age ≥18 years at the time of enrollment
Suspected primary non-muscle invasive bladder cancer (NMIBC; stage pTa or pT1) based on cystoscopic assessment, with no radiological or clinical evidence of muscle-invasive disease
Solitary or multiple bladder tumors with an estimated largest diameter of ≤50 mm based on flexible or rigid cystoscopic assessment (or cross-sectional imaging if available)
Clinical indication for elective transurethral resection of the bladder tumor, planned to be performed as en-bloc resection
Known or clinically suspected muscle-invasive bladder cancer (MIBC; cT2 or higher) based on cystoscopy or imaging
Recurrent bladder tumor (prior history of bladder tumor resection within the past 24 months)
Active untreated urinary tract infection at the time of surgery (requiring postponement and re-evaluation)
Uncorrectable coagulopathy or anticoagulation that cannot be safely paused perioperatively
Single group
CURTIS retrieval device
DeviceAfter successful en-bloc resection, the tumor is retrieved using the novel retrieval device, where the tumor is catched with a bag and removed through the urethra
Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
Proportion of enrolled patients in whom the CURTIS device enables complete, intact retrieval of the en-bloc resected bladder tumor specimen without fragmentation within the bladder or urethra. A case is classified as a technical success if the entire resected specimen is extracted through the urethra in one piece using the CURTIS device. Cases requiring conversion to an alternative retrieval method (e.g., piecemeal extraction, Ellik evacuator, endoscopic bag) are classified as technical failures.
Maximum Retrievable Tumor Size
Largest tumor diameter (in mm) at which successful intact retrieval using CURTIS was achieved, used to define a clinically meaningful upper size limit for CURTIS-assisted EBR-T.
Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)
Proportion of retrieved specimens containing detrusor muscle on pathological examination.
Proportion of Specimens Permitting Complete Pathological T-Stage Assessment
Proportion of retrieved specimens allowing complete pathological T-stage assessment (pTa/pT1/pT2+).
Proportion of Specimens Permitting Histological Grading
Proportion of retrieved specimens permitting grading according to WHO 2022 classification.
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