Hematuria is among the most common presenting abnormalities in urology practice and poses a diagnostic dilemma as the etiology of hematuria can be very diverse and may be a clinically insignificant or life-threatening condition, such as a urinary tract malignancy. Hematuria can be either visible (gross, macroscopic) or invisible (microscopic). While visible hematuria is more of a concern for important urological disease, microscopic hematuria can be the first symptom of a bladder cancer, upper urinary cancer or renal cancer. Today, microscopic hematuria is defined as the detection of 3 or more RBCs in a high-power field of a properly collected urine specimen on microscopic examination, but presence of a positive urine dipstick alone is not enough to make the diagnosis [1,2]. The task for the clinician is not just to detect blood in the urine, but to be able to identify those patients who need comprehensive investigation and those who can safely be repeated tested of assessed for potential further investigation.

Differential diagnosis of hematuria is quite a wide one which encompasses urinary tract infection, urolithiasis, benign prostatic hyperplasia, renal parenchymal disease, trauma-related hematuria, medication-related hematuria and genitourinary malignancies. In many patients with hematuria, bladder cancer is by far the most significant malignant diagnosis to exclude, and renal cell carcinoma and upper tract urothelial carcinoma are less common but important causes [3,4]. Patients with hematuria who underwent a systematic review showed that the overall incidence of urinary tract malignancy is widely ranging, depending on the patient characteristics and type of hematuria. The likelihood of malignancy is significantly higher for visible than microscopic hematuria, and for older age, male sex, smoking history, and other known risk factors for urothelial cancer, the number of cancers is significantly higher [3]. Treatment for all patients who present with hematuria as having the same potential risk of cancer could result in unnecessary invasive testing in patients who have low risk or delayed diagnosis in those who have high risk.

A major focus in the assessment of modern hematuria is thus the concept of risk stratification. The American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (AUA/SUFU) guideline recommends classification of patients with microscopic hematuria according to age, sex, smoking exposure, degree of hematuria, persistence of hematuria, history of gross hematuria, and additional urothelial cancer risk factors [1,2]. Further refinement of the risk categories was done in the 2025 guideline amendment, where the estimated risk of malignancy is increased along the low/negligible-, intermediate-, and high-risk categories [1]. This method takes into account that comprehensive diagnostic testing is not likely to yield the same benefit to all patients. Repeat urinalysis and shared decision making is a good option for low-risk patients, while intermediate-risk patients typically require cystoscopic evaluation and renal ultrasound. In high-risk patients, more extensive evaluation is needed and is frequently performed with cystoscopy and computed tomography urography [1] of the axial upper tract.

The rationale for risk based investigation is based on evidence that unselected patients with microscopic hematuria have relatively low diagnostic yield. In a systematic review and meta-analysis of over 24,000 patients evaluated for microscopic hematuria, pooled diagnostic yields were around 2.0% for bladder cancer, 0.02% for upper tract urothelial carcinoma and 0.18% for renal cell carcinoma [5]. In populations where there were known high-risk characteristics, however, the diagnostic yields rose significantly, favoring the use of an imaging test on a more selective basis than indiscriminately. Overuse of computed tomography urography can result in unnecessary health care costs, repeated investigations, incidental findings, intravenous (IV) contrast exposure, and excessive ionizing radiation exposure for the patient without proportional diagnostic value [6,7]. On the other hand, failing to investigate high risk hematuria may lead to under diagnosis or late diagnosis of malignancy.

Despite the availability of imaging modalities that may not detect small, flat or mucosal bladder cancers, cystoscopy is an important part of bladder cancer detection. Cystoscopy in adults with hematuria remains a fundamental diagnostic tool for direct evaluation of the bladder, as shown by a recent systematic review performed by the European Association of Urology [8]. Upper-tract imaging can be used in conjunction with cystoscopy to help assess the kidney and ureters, but the choice of which imaging modality to use (ultrasound or CT) should be based on the estimated malignancy risk of the patient [1,5]. Additionally, there is some evidence that indiscriminate use of CT urography has a relatively low diagnostic yield in the upper tract in younger patients with negative cystoscopy [6]. These results highlight the need to consider the right investigation for the right person and to not follow an escalating diagnostic pathway.

Another important issue is the possibility of seemingly innocent explanations to being able to postpone the investigation of malignant disease. Common diagnoses such as urinary tract infection, nephrolithiasis, or others seen in the presence of hematuria can coexist or be the precursor to hematuria and these should be considered when evaluating the patient, but if hematuria persists or occurs in a recurrent fashion after treatment, other diseases should be considered and re-assessment performed. Especially, hematuria in women can be misinterpreted as a urinary infection, which can cause a delay in the evaluation of bladder cancer [9]. Likewise, there is no strict rule that if a patient is on an anticoagulant or antiplatelet agent, this is always enough to explain the hematuria. Recent studies suggest that clinically relevant urological malignancy can be detected in patients with hematuria who are on anticoagulants, and therefore, the urinary tract should not be disregarded because of just the fact that the patient is on an anticoagulant [10,11].

More recently, prediction models have been shown to have potential utility to better clarify hematuria assessment. The IDENTIFY collaborative study prospectively analyzed over 10,000 patients who were referred with hematuria and showed that several easily available clinical parameters could be combined into a multivariable model that would estimate the likelihood of urinary tract cancer [12]. Likewise, the Hematuria Cancer Risk Score which includes history of smoking, hematuria type, and age and sex has been shown to have good discriminatory ability for the diagnosis of urinary tract malignancy [13,14]. More recent validation studies of risk-based approaches have shown that there may be potential to further decrease unnecessary cystoscopy without compromising the sensitivity for clinically significant malignancy when using risk-based approaches with ultrasound [14]. These advances present a foundation for determining whether a structured algorithm can enhance the diagnostic efficiency without compromising the detection of cancer.

Although the risk stratification has improved, there is considerable variation in clinical practice in terms of the threshold for investigation, imaging selection, cystoscopy and follow-up of apparently low-risk patients. In the context of limited resources in health care settings, balancing the risk of unnecessary procedures with the risk of missing malignancy is of particular importance, and may lead to the end of indiscriminate use of CT urography and cystoscopy. Such a prospective evaluation of patients presenting with hematuria can thus provide important real-world data on the association between clinical risk factors, diagnostic evaluations, and definitive diagnosis.

To assess the performance of a risk-stratified work-up algorithm for patients with hematuria, and to test whether clinical characteristics are effective in separating patients who need a prompt comprehensive urological evaluation from those who can be investigated by a conservative or targeted approach. For this study, the specific association of type of hematuria, age, sex, smoking, degree of hematuria, persistence of hematuria, urinary symptoms, relevant comorbidities and other risk factors with significant urological pathology was assessed. This study was designed to see if a structured approach would have a diagnostic yield when compared to the results of investigations conducted and final diagnoses made and to identify characteristics of clinical presentations that warrant escalation of investigation. This could be beneficial in the early diagnosis of malignancy in patients at higher risk and in reducing unnecessary investigations in low-risk patients.

It was a prospective observational study carried out in the Department of Urology, Ayub Teaching Hospital, Abbottabad for 6 months. Patients ≥18 years of age with gross and/or microscopic hematuria were consecutively enrolled as adults. Patients with a previous history of urinary tract malignancy, recent urological surgery or trauma, menstruation on the day of urine collection and those who refused participation were excluded. Demographic and clinical data, such as age, sex, smoking history, type of hematuria, duration of hematuria, recurrent UTI, urolithiasis, BPH, family history of urothelial malignancy, and use of anticoagulants were noted. Urine routine examination and microscopy, urine culture if indicated, complete blood count, serum creatinine and estimated glomerular filtration rate were among the initial investigations.

Patients were then divided into low, intermediate, and high-risk groups based on the following factors: age, sex, smoking exposure, extent and duration of hematuria, history of gross hematuria, and other known risk factors for urinary tract malignancy. Repeat urinalysis and clinical follow-up was performed for low-risk patients, while intermediate-risk patients had cystoscopy and renal/bladder ultrasonography. Cystoscopy with upper urinary tract imaging (preferably CT urography) was performed in patients at high risk. Cystoscopy and imaging identified suspicious lesions that were then resected and/or biopsied and sent to the histopathological lab. The primary outcome was the presence of clinically relevant urologic disease, specifically genitourinary malignancy. Secondary outcomes were diagnostic yield by risk category and the clinical factors that were associated with significant pathology. The data were analyzed using SPSS, and appropriate parametric and non-parametric tests were used for the assessment of the categorical and continuous variables respectively. The criteria for statistical significance was p value < 0.05. The institutional committee approved the study and informed written consent was obtained from all participants.

A total of 120 patients with hematuria were enrolled. The mean age was 52.6 ± 15.8 years, with 72 (60.0%) males and 48 (40.0%) females. The most common presentation was visible hematuria (68, 56.7%) and microscopic hematuria (52, 43.3%). 38(31.7%) patients were identified by the pre-defined risk-stratification algorithm as low risk, 44 (36.7%) as intermediate risk, and 38 (31.7%) as high risk. The most common associated risk factors were smoking history, recurrent urinary tract infection, and history of urolithiasis.

Table 1. Baseline demographic and clinical characteristics of patients

*Among male participants.

The diagnostic pathway varied according to risk category. Repeat urinalysis was sufficient for initial management in most low-risk patients, whereas cystoscopy and renal/bladder ultrasonography were predominantly used in the intermediate-risk group. High-risk patients underwent cystoscopy with upper urinary tract imaging, with CT urography performed in 34 (89.5%) high-risk patients. Overall, cystoscopy was performed in 82 (68.3%) patients.

Table 2. Investigations and major diagnostic findings according to risk category

Patients by hematuria risk category

Distribution of the 120 study participants according to the predefined risk-stratification algorithm.

Histopathological examination of suspicious lesions identified 12 cases of genitourinary malignancy (10.0%). Bladder urothelial carcinoma was the most frequent malignant diagnosis, accounting for 9 cases (7.5%), followed by renal cell carcinoma in 2 (1.7%) and upper tract urothelial carcinoma in 1 (0.8%). Malignancy was strongly concentrated in the high-risk group: 9 of 38 high-risk patients (23.7%) had malignancy compared with 3 of 44 (6.8%) intermediate-risk patients and none of the 38 low-risk patients. The difference between risk categories was statistically significant (p = 0.003).

Table 3. Final diagnoses according to risk category

Detection of genitourinary malignancy by risk category

Malignancy detection increased progressively with hematuria risk category.

In general, the risk stratified approach was effective in picking up all 12 cases of malignancy in the intermediate and high-risk groups and in reducing additional extensive investigations for the majority of low-risk groups. In patients who had seen blood in the urine, 11 (16.2%) had malignancy, but only 1 (1.9%) those with microscopic hematuria (p = 0.012). History of smoking was also significantly related to malignancy, with 8 (20.5%) smokers having malignancy versus 4 (4.9%) nonsmokers (p = 0.009). These results confirmed that visible hematuria, the risk categories and smoking were significant factors in predicting clinically significant urological disease.

In this prospective observational study, the authors demonstrated that a risk-stratified approach for evaluation of hematuria could identify patients with a relatively low risk of clinically significant urological disease and the patients with a high risk of clinically significant urological disease. In 120 patients evaluated, a malignancy was found in 12 (10.0%), none of the patients in the low risk group were malignant, 6.8% of patients in the intermediate risk group were malignant and 23.7% of patients in the high risk group were malignant. This fact that the rate of malignancy detection increases with the risk category helps to confirm the principle behind current guidelines for the management of hematuria that the level of investigation should match the level of risk and not be the same for all patients [17]. The revised AUA/SUFU guideline also highlights new risk stratification and risk stratification directed approach to cystoscopy and upper tract imaging. Visible hematuria was significantly associated with malignancy in the present study. Hematuria was also observed in 16.2% of people with visible blood in the urine, and 1.9% of people with only microscopic blood in the urine. This is clinically significant as visible hematuria continues to be one of the best presenting signs of urinary tract malignancy and the urological evaluation should be done promptly and is warranted in most cases, especially for older patients and those with other risk factors. New literature also favors the separation of visible and non-visible hematuria in estimating the risk of cancer and deciding to investigate [18]. But the presence of microscopic hematuria cannot be ignored, especially in the presence of other risk factors like smoking and advanced age.

Another significant factor which was related to malignancy in our population of smokers was smoking. About one-fifth of the smokers were diagnosed with a malignant condition, compared with less than 5% of the nonsmokers. Exposure to tobacco is a well-established risk factor for urothelial carcinoma and is included as a component in modern urothelial carcinoma risk-stratification models. Age, male sex, smoking exposure, and amount of haematuria all play a significant role in the prediction of urothelial malignancy and have been validated recently [19]. Therefore, it's important to document smoking history systematically at initial assessment, not as a background demographic data.

The distribution of malignant diagnoses in our study was also comparable to that of bladder urothelial carcinoma being the predominant diagnosis in patients who underwent investigation for hematuria, as would be expected. Bladder cancer was seen in 9 of 12 cases and renal cell and upper tract urothelial cancer were seen less often. This finding underscores the need for cystoscopy as a core element in the workup of patients at high risk. The systematic review recently performed by the European Association of Urology (EAU) also validated the use of cystoscopy for bladder cancer diagnosis in adults with hematuria [20]. In our study, cystoscopy was done in all the high risk cases and we found the bladder lesions to be suspicious mostly in these cases. Also, imaging of the upper tract was directed by the risk category. In high risk patients, CT urography was the method of choice and in intermediate risk patients, ultrasound was employed more. This may decrease unnecessary radiation exposure and contrast related risks, while maintaining access to more sensitive upper tract imaging when clinically indicated. Evidence assessing risk-based approaches has shown that in all patients with hematuria, the use of CT urography offers little benefit in terms of diagnosis compared to its potential harm and cost [21]. So selective imaging seems to be especially relevant in situations where resources are limited in health care. One of the key results of the present study was the absence of malignancy in the low-risk patients, despite the fact that they did have hematuria present. This is in line with the notion that selected low-risk patients might benefit from repeat urinalysis and clinical follow-up before embarking on invasive investigation. Structured risk stratification has been shown to be effective in other contemporary studies for reducing the extent of evaluation in patients with a low likelihood of malignancy [22]. However, low risk is not synonymous with absence of malignancy; if hematuria persists or recurs, it should cause a re-evaluation of the situation, with further investigation and possibly a more aggressive approach.

The findings also warrant the potential benefit of clinical prediction tools. The Hematuria Cancer Risk Score uses risk factors like age, gender, type of hematuria, and smoking status to calculate the risk of urinary tract cancer. Recent studies showed that this score when coupled with ultrasound, could influence the decision for cystoscopy and decrease unnecessary procedures without compromising clinically valuable cancer detection [23]. Other recent studies using external validation have investigated the use of risk calculators and machine learning techniques for patients referred with hematuria, indicating that individualised prediction in the future may be more important in diagnostic pathways [24]. The clinical significance of these findings cannot be neglected especially in the context of limited health care resources. The use of a common protocol with all patients having cystoscopy and CT urography will lead to excess radiation, invasive procedures, patient stress, and higher healthcare costs. On the other hand, a very conservative approach could result in the delayed diagnosis of high-risk patients. The present results indicate that a well-defined pathway, based on age, type of hematuria, smoking history, persistence and other clinical criteria, may offer a pragmatic compromise between these conflicting interests.

There were a number of limitations in this study. It was carried out in a single tertiary-care hospital and a relatively small sample size which may not represent other populations. Six months follow-up was also a short period to assess for delayed malignancy in patients who initially had negative investigations. Furthermore, the risk stratification algorithm was tested in a real-world clinical setting, in which the use of imaging and clinician judgment may affect the decision on what investigations to pursue. The algorithm needs to be further validated in larger multicenter prospective studies with longer follow-up, and cost-effectiveness and safety needs to be established. The overall results of the findings are in favor of a “risk first, investigation second” strategy for hematuria. All patients with visible blood should be evaluated in detail by a urologist, but for carefully selected low-risk patients, wait-and-watch management may be appropriate. The malignancy rates seen in the intermediate- and high-risk groups indicate that risk-stratified assessment might avoid investigations in patients where they are not clinically necessary without missing the diagnosis of clinically significant urinary tract malignancy.

This is a prospective observational study that showed a risk-stratified approach offered a clinically useful and pragmatic tool to assess patients with hematuria. Malignancy was found in patients with intermediate-risk and high-risk features, such as visible hematuria and a smoking history, but not in those in the low-risk group. These results confirm that it is worthwhile to investigate patients with hematuria individually rather than by extensive testing of all patients with hematuria. A well-designed algorithm, combining age, hematuria type, smoking history, persistence of hematuria, and other clinical risk factors could allow for a reasonable balance between early detection of a urinary tract malignancy and unnecessary invasive procedures and advanced imaging.

Recommendations

The standardized risk-stratification algorithm should be used in the normal evaluation of patients with hematuria at urology clinics. Complete comprehensive urological evaluation should be performed promptly on patients with visible or persistent hematuria, advanced age, heavy smoking or other high-risk features, including cystoscopy and suitable imaging of the upper tract. Repeat urinalysis and clinical surveillance may be used to treat patients at low risk of the disease, although ongoing or recurrent hematuria should lead to further investigation. Hematuria must not be considered as a sole diagnosis of UTI or anticoagulant therapy and should be reassessed. This algorithm needs to be validated in larger multicenter prospective studies with more follow-up, assess its cost effectiveness and its effectiveness in reducing unnecessary investigations while maintaining high sensitivity for clinically important malignancy.

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