An observational study in Urologic Diseases, Hematuria and Hematuria; Benign, sponsored by British Urology Researchers in Surgical Training. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by British Urology Researchers in Surgical Training · Observational
This multicenter, prospective observational study will evaluate national and international practice variations (if present) in the emergency management of patients admitted to hospital with haematuria, inform a consensus guideline for best practice and provide evidence to design an implementation study to optimise haematuria management pathway.
The WASHOUT study is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria. The study will utilise a collaborative methodology using the BURST model. Data on demographics, comorbidities, management practices, and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover diagnosis time, 90-day mortality, readmission rates, and resource use.
Patient and public involvement has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern
Study design and aim WASHOUT is an international, multicentre prospective observational study aiming to describe the management of haematuria emergency admissions.
Objectives:
Our objectives are:
Establish the incidence of causative diagnoses in patients being admitted with emergency haematuria.
Describe demographics, comorbidities, management and clinical outcomes of patients undergoing emergency admission to hospital with haematuria.
Identify factors associated with adverse outcomes and/or increased resource use.
Identify if variation in management and outcomes exists at local, regional and international levels.
Assess the impact different management pathways have on clinical outcomes (in terms of length of stay, health resource utilisation, readmission, 30-day and 90-day mortality rates Provide information to design a future randomised trial, for example control group outcomes and estimates of intra-cluster correlations.
Inclusion criteria Patients will be included consecutively if they are over 18 years of age and admitted to a participating secondary care centre as an emergency with haematuria under the primary or joint care of the urology team.
In the UK, individual consent is not necessary as this study has been considered a service evaluation.
Exclusion criteria any patients with catheter-related urethral trauma (defined as haematuria immediately after insertion of a urethral catheter without a preceding history of haematuria on this admission including traumatic catheter removal by patients), urological trauma (abdominal/pelvic) as well as patients who are in hospital less than 24 hours.
Primary outcome Length of stay, measured as the number of calendar days between the day of admission in the index hospital admission episode and the day of discharge from the hospital.
Secondary outcomes Time to definitive diagnosis measure, defined as the number of days between original presentation and final diagnosis.
30-day and 90-day mortality rate measured as the number of patients who died from the day of admission to the 30-day and 90-day follow-up period.
30-day and 90-day readmission rate, measured as the number of patients who were readmitted to the hospital with the same issue in the 30 days and 90-day after the date of discharge.
Number of days alive and out of hospital at 90 days. Healthcare costs, measured by calculating the cost of the stay, investigations, procedures, the patient underwent during the admission and in the 90-day follow-up period including readmissions.
The study will also assess current pathways that exist in hospitals, including acute care pathways and specific pathways for management of haematuria. Details will be obtained through a questionnaire distributed to each participating site.
Study delivery The study will utilise the The British Urology Researchers in Surgical Training (BURST) collaborative model. The design of the current study has been supported by input from the Centre for Healthcare Randomised Trials (CHaRT) (i.e. The Urology Foundation trials unit), who will be involved in designing and conducting the next study, which we anticipate will be an implementation randomised controlled trial.
Recruitment Patients will be recruited consecutively. The recruitment target for this study is based pragmatically on the prevalence of inpatient haematuria. Target recruitment per participating site is 15 patients across a 12-month period from 70 centres. The cumulative recruitment target from all sites is 1,050 patients. We want to recruit as many participants as possible during the 12-month period. The sample size is also based on the anticipated wide variation of practice and the heterogeneous nature of the presentation in terms of patient demographics and the underlying cause of the haematuria ranging from benign causes to malignant urological conditions. This sample size is also adequately powered to detect a meaningful difference in length of stay (defined as at least 1 day by study authors) using ANOVA to analyse any binary variable (spanning both clinicopathological features and management factors). This 1-day difference in length of stay is based on a calculated sample size of 1,054 patients, obtaining a power of 0.90 with a significance level of 0.05, and taking a standard deviation of length of stay as 5 days obtained from original data of a retrospective review covering this study population [2].
221 studies on the registry are indexed under Urologic Diseases; 48 are open to participants now.
This study's planned enrollment of 1,050 is above the median of 200 across 49 observational studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →British Urology Researchers in Surgical Training is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be included consecutively if they are over 18 years of age and admitted to a participating secondary care centre as an emergency with haematuria under the primary or joint care of the urology team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients meeting above defined inclusion and exclusion criteria. This study will take place in urological secondary and tertiary care centres internationally. The study will be conducted in centres that agree to participate in the study and meet the study's inclusion criteria below.
Other: Inpatient work-up and management
The study hypothesis is that there is significant international and national variation in the diagnostic workup and management of patients requiring admission to the hospital with haematuria. Increased length of stay and poor outcomes in terms of mortality and healthcare costs are associated with management practices. The CRF will collect datapoints on inpatient work-up and management.
Length of inpatient stay
Number of calendar days between the day of admission in the index hospital admission episode and the day of discharge from the hospital.
Time frame: At 90 days
Mortality rate
Time frame: At 90 days
Readmission rate
Time frame: At 90 days
Time to definitive diagnosis
Defined as the number of days between original presentation and final diagnosis.
Time frame: At 90 days
Number of days alive and out of hospital
Composite endpoint - cumulative days alive and out of hospital
Time frame: At 90 days.
Resource use
Calculating the cost of the inpatient stay, investigations, procedures, the patient underwent during the admission and in the follow-up period
Time frame: At 90 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Apr 2026, 27 months after the start.
Of 36 observational studies under Urologic Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 20. This study's planned 27 months is below that.
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British Urology Researchers in Surgical Training