Bladder CancerBWashNCT05643807
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?
A study testing Flexible cystoscopy and Urinary catheter in people with Bladder Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Flexible cystoscopy and Urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Feb 2023to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged > or = 18 years
- Patients scheduled for a flexible cystoscopy and urinary cytology.
- Patients who have signed the informed consent.
- Patients who speak French
Who cannot join
- Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy
- Inability to give informed consent or without capacity of discernment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois, CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study
Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.
Read the detailed description
The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient.
Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.
Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).
- Conditions
- Bladder Cancer
- Being tested
- Flexible cystoscopy, Urinary catheter
- Keywords
- Bladder cancer, Urinary cytology
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible cystoscopyDevice
Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).
Urinary catheterDevice
Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| urinary catheter | Active comparator | Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level. Receives: Device: Urinary catheter |
| flexible cystoscope | Active comparator | Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present). Receives: Device: Flexible cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of urinary cytology according to the tool used for collection of both groups
Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure
Measured: 2 years
Secondary outcomes (2)
The sensitivity and sensibility of the urinary cytology of both groups
Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy
Measured: 2 years
The satisfaction of patients of both groups
The Faces Pain Scale will be used for each patient after the cytology to assess his satisfaction/pain (0= no pain and 10=the worst pain possible)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start8 Feb 2023
- Primary completion2 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Lucca, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643807
- Sponsor's protocol ID
- 2021-01124
- Acronym
- BWash
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05643807
- Acronym / sponsor ID
- BWash / 2021-01124
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Urinary cytology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.
Detailed description
The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient.
Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.
Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urinary catheter | Active comparator | Device: Urinary catheterUrinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level. |
| flexible cystoscope | Active comparator | Device: Flexible cystoscopyUrinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged > or = 18 years
- Patients scheduled for a flexible cystoscopy and urinary cytology.
- Patients who have signed the informed consent.
- Patients who speak French
Key exclusion criteria (2 listed)
- Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy
- Inability to give informed consent or without capacity of discernment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible cystoscopyUrinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present). | Device | flexible cystoscope |
| Urinary catheterUrinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy | Device | urinary catheter |
Primary outcome
The quality of urinary cytology according to the tool used for collection of both groups
Time frame: 2 years
Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure
2 secondary outcomes
The sensitivity and sensibility of the urinary cytology of both groups
Time frame: 2 years
The satisfaction of patients of both groups
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible cystoscopy and Urinary catheter in people with Bladder Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of urinary cytology according to the tool used for collection of both groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.