Assessing the safety and effectiveness of a biopsy instrument when sampling tumours in the urinary bladder

ISRCTN	ISRCTN80990426
DOI	https://doi.org/10.1186/ISRCTN80990426
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CIV-20-05-032908
Sponsor	Skåne University Hospital
Funder	Skåne Region Health Care Fund for Development and Innovation

Submission date: 30/07/2020
Registration date: 10/09/2020
Last edited: 25/09/2025

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Muscle-invasive bladder cancer is cancer that has spread into the muscle wall of the bladder. Treatment is based on taking a biopsy (sample) of the tumor. Today a biopsy is retrieved by a surgical procedure called transurethral resection under anesthetic before treatment with either neoadjuvant chemotherapy (drug treatment) and cystectomy (removal of the bladder) or cystectomy only. The aim of this study is to investigate a new biopsy device (Urodrill) for diagnosing muscle-invasive bladder cancer under local anesthetic.

Who can participate?
Patients aged 18 and over with suspected muscle-invasive bladder cancer

What does the study involve?
Participants are randomly allocated to undergo either standard transurethral resection or an endoscopic biopsy under local anesthetic with the Urodrill instrument.

What are the possible benefits and risks of participating?
The benefit from participating is a chance to avoid a transurethral resection of the bladder tumor under anesthetic and instead have a local anesthetic procedure in the outpatient clinic. The risks are related to biopsying the tumor in the conventional and experimental group mainly relating to bleeding after the procedure and perforation.

Where is the study run from?
Skåne University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
November 2019 to June 2026

Who is funding the study?
Skåne Region Health Care Fund for Development and Innovation (Sweden)

Who is the main contact?
Prof. Fredrik Liedberg
fredrik.liedberg@med.lu.se

Contact information

Prof Fredrik Liedberg
Scientific

Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden

ORCID ID	0000-0001-8193-0370
Phone	+46 (0)40 33 19 41
Email	fredrik.liedberg@med.lu.se

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Safety and efficacy of the EndoDrill® Uro X biopsy instrument when sampling tumours in the urinary bladder
Study acronym	Urodrill study
Study objectives	Time from radiological suspicion to start of definitive treatment for muscle-invasive bladder cancer can be decreased by using the Urodrill pathway.
Ethics approval(s)	Approved 18/03/2020, National Ethical Committee (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2019-06537
Health condition(s) or problem(s) studied	Bladder cancer
Intervention	Method of randomisation: closed envelopes Conventional arm: standard transurethral resection Experimental arm: endoscopic biopsy under local anesthesia with the Urodrill instrument
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Time from radiological suspicion of MIBC to start of definitive treatment for MIBC (neoadjuvant chemotherapy and/or cystectomy): measured using prospective registration at day for radiological report stating suspicion of MIBC to starting day of neoadjuvant chemotherapy, or cystectomy for those operated without neoadjuvant chemotherapy by prospective registration
Key secondary outcome measure(s)	1. Complications from the EndoDrill biopsy procedure assessed by a structured telephone interview 2 weeks after the procedure 2. Proportion of patients with MIBC that the EndoDrill® Uro X -instrument failed to detect, but diagnosed with ordinary TURBT, measured using pathology at [at secondary procedure with TURBT for those in the experimental arm without verification of MIBC and with MIBC verified by TURBT 3. Proportion of patients with successful molecular classification based on RNA sequencing performed in real time with 6 weeks of sampling in both arms 4. Cancer-specific survival (CSS) measured using chart review at 24 months after initiating definitive treatment for MIBC 5. Overall proportion of patients who correctly followed the protocol and were staged as MIBC in the intervention arm, measured using chart review within 3 months of inclusion 6. Cost-effectiveness based on EQ5D5L at baseline and 2 weeks 7. Quality of life measured using FACT-G questionnaire preoperatively and FACT-VCI at 12 months 8. Adverse events assessed during a phone interview by a research nurse 2 weeks after the procedures 9. Sensitivity and specificity for CT-urography and MRI respectively to accurately determine muscle-invasive bladder cancer compared to the outcome of the combined measure of biopsy and cystectomy specimen, measured using sensitivity calculations compared to pathology within 3 months of inclusion
Completion date	30/06/2026
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	74
Key inclusion criteria	1. Provision of written informed consent 2. ≥18 years of age 3. Patients attending participating urology departments for haematuria investigation and CT-urography suspicious of muscle-invasive bladder cancer
Key exclusion criteria	1. Patients unable or unwilling to undergo EndoDrill biopsy 2. Bleeding diathesis prohibiting EndoDrill biopsies 3. Ongoing immunosuppression (except corticosteroids in moderate doses, less than 10 mg prednisolone or equivalent daily) 4. Patients not suitable/fit for radical treatment for MIBC 5. Pregnancy
Date of first enrolment	01/10/2020
Date of final enrolment	30/06/2026

Locations

Countries of recruitment

Sweden

Study participating centre

Skånes Universitetssjukhus

Department of Urology
Jan Waldenströms gata 7
Malmö
205 02
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated in the present study will not be stored in a publically available repository due to the small study size and mainly descriptive data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	Prior feasibility study results	02/06/2023	17/09/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/09/2025: The randomized trial in this record did not commence; the linked publication provides results from a proof-of-concept feasibility study with a date of final enrolment of 30/09/2022.
17/09/2025: Publication reference added.
19/12/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 30/06/2026.
2. The overall end date was changed from 31/12/2024 to 30/06/2026.
3. The intention to publish date was changed from 31/05/2025 to 31/05/2027.
04/01/2024: The study record was confirmed as being up to date.
15/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/12/2024.
2. The intention to publish date was changed from 31/05/2023 to 31/05/2025.
3. The plain English summary was updated to reflect these changes.
17/03/2022: The recruitment end date has been changed from 31/12/2022 to 31/12/2024.
04/08/2020: Trial's existence confirmed by the National Ethical Committee (Etikprövningsmyndigheten).