Safely reduce cystoscopic evaluations for microscopic Hematuria patients (SeARCH Trial).

Safely reduce cystoscopic evaluations for microscopic Hematuria patients (SeARCH Trial). - SeARCH Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56042

Enrollment

1100

Registered

2022-12-12

Start date

2023-05-31

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic hematuria red blood cells in urine

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study a written informed consent is required. Thereby, a subject must meet the following criteria based on the most recent American Urological Association guideline on microscopic hematuria 2020. - Microscopically confirmed microscopic hematuria of voided urine defined as >=3 erythrocytes per high power field - Male patients >=40 years - Female patients >=50 years

Exclusion criteria

Exclusion criteria: - History of urothelial bladder- or urinary tract cancer - Presence of macroscopic (visible) hematuria - Woman who is or may be pregnant

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the net benefit of the urine-first strategy versus the care-as-usual, which is a cystoscopy in all patients presenting with microscopic hematuria. The net benefit is a decision analytic measure to evaluate the clinical implementation of an intervention commonly used in health.(17) In clinical decision models, the net benefit calculation determines whether implementing an intervention would do more good or harm (a positive value indicates a positive effect). This is achieved by putting the benefits (detection of a bladder tumor) and harms (performing diagnostic evaluation without any abnormal finding) on the same scale and multiplying the harms with a decision threshold. The decision threshold represents the estimated harms of the diagnostic intervention, such as the risk for a urinary tract infection, patients* burden, and use of available resources, against the harms of an outcome event, i.e. missing a bladder tumor. As previously reported, the decision threshold for evaluation of microscopic hematuria patients is determined at 3% (1 divided by 30). Meaning that a urologist is willing to conduct 30 cystoscopies to detect 1 bladder tumor.	—

Measure

Time frame

The primary endpoint is the net benefit of the *urine-first* strategy versus the *care-as-usual*, which is a cystoscopy in all patients presenting with microscopic hematuria. The net benefit is a decision analytic measure to evaluate the clinical implementation of an intervention commonly used in health.(17) In clinical decision models, the net benefit calculation determines whether implementing an intervention would do more good or harm (a positive value indicates a positive effect). This is achieved by putting the benefits (detection of a bladder tumor) and harms (performing diagnostic evaluation without any abnormal finding) on the same scale and multiplying the harms with a decision threshold. The decision threshold represents the estimated harms of the diagnostic intervention, such as the risk for a urinary tract infection, patients* burden, and use of available resources, against the harms of an outcome event, i.e. missing a bladder tumor. As previously reported, the decision threshold for evaluation of microscopic hematuria patients is determined at 3% (1 divided by 30). Meaning that a urologist is willing to conduct 30 cystoscopies to detect 1 bladder tumor.

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Secondary

Measure	Time frame
The secondary outcomes are I) the number of cystoscopies and upper tract imaging modalities (CT or ultrasound) II) cost-effectiveness and III) patient burden. These outcomes will be directly compared between the care-as-usual arm, a cystoscopy and upper tract imaging for all patients presenting with microscopic hematuria versus the urine-first strategy, in which only patients with an abnormal test result undergo diagnostic evaluation.	—

Measure

Time frame

The secondary outcomes are I) the number of cystoscopies and upper tract imaging modalities (CT or ultrasound) II) cost-effectiveness and III) patient burden. These outcomes will be directly compared between the *care-as-usual* arm, a cystoscopy and upper tract imaging for all patients presenting with microscopic hematuria versus the *urine-first* strategy, in which only patients with an abnormal test result undergo diagnostic evaluation.

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Countries

Netherlands

Outcome results