Nurse-led hematuria (blood in urine) clinic – a prospective trial
| ISRCTN | ISRCTN15685750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15685750 |
- Submission date
- 04/01/2023
- Registration date
- 20/02/2023
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
We want to study how well a new test for bladder cancer (the IB-test) works when used by nurses to quickly check for bladder cancer in people who have blood in their urine (hematuria). We also want to see if using nurses to do this test instead of doctors can save time and money. We will study this in women who are 50 or older and have blood in their urine in two different hospitals. We will also look at how well the test works and the cost of using it.
Who can participate?
All females above 50 years of age subject to investigation for visible hematuria in two hospitals.
What does the study involve?
Patients attending different centres will either undergo standardized care pathways or the nurse-led rapid access clinic and the use of diagnostic test (IB-test). Follow-up is for a minimum of 3 months.
What are the possible benefits and risks of participating?
No risks, but a possible benefit from earlier cystoscopy compared to urologist-led outpatient clinic examination.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
October 2022 to June 2026
Who is funding the study?
Skåne University Hospital (Sweden)
Who is the main contact?
Prof. Liedberg, anki.rosberg@med.lu.se
Contact information
Principal Investigator
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
20502
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46 40-33 10 00 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Prospective interventional cluster crossover |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Other cluster crossover design |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | CYstoskopi av kontaktsjuksköterska vid utredning för SynligT blod i urinEn hos kvinnoR – CYSTER-studien |
| Study acronym | CYSTER |
| Study hypothesis | Shortened time to bladder cancer diagnosis in a nurse-led rapid access clinic compared to standardized care pathways for females with visible hematuria. |
| Ethics approval(s) | Approved 22/12/2022, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se): ref: Dnr 2022-06049-01 |
| Condition | Macroscopic hematuria |
| Intervention | Intervention clusters: nurse-led rapid access clinic and the use of diagnostic test (IB-test). Control clusters: standardized care pathways Patients are included prior to diagnostic cystoscopy for macroscopic hematuria. The total duration of follow-up is until study closure with minimum of 3 months of follow-up to have full information on all outcomes related to the macroscopic hematuria evaluation. |
| Intervention type | Other |
| Primary outcome measure | Time from hematuria to cystoscopy/bladder cancer diagnosis measured using patient records. |
| Secondary outcome measures | 1. Patient reported experience measures (PREM): urography or cystoscopy PREM - Validated national questionnaire for patient-reported outcomes - filled in by patient after cystoscopy 2. Cost effectiveness measured using EQ-5D-5L and direct costs extracted from patient charts at the end of the study 3. Sensitivity and specificity for the IB-test to detect bladder cancer measured by comparing the IB test result to the actual outcome (positive or negative) at the end of the study |
| Overall study start date | 26/10/2022 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Female |
| Target number of participants | 800 |
| Participant inclusion criteria | 1. Female 2. Hematuria referral 3. Aged 50 years or older |
| Participant exclusion criteria | 1. Age below 50 years 2. Lack of informed consent |
| Recruitment start date | 25/01/2023 |
| Recruitment end date | 30/06/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Växjö
35234
Sweden
Malmö
20502
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Jan Waldenströmsgata 5
Malmö
20502
Sweden
| Phone | +46-40 333751 |
|---|---|
| anki.rosberg@med.lu.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Skåne University Hospital, SUS
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Not expected to be available due to confidentiality. |
Editorial Notes
19/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 30/06/2026.
2. The overall study end date was changed from 31/12/2025 to 30/06/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/05/2027.
13/01/2023: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
