TY - JOUR

T1 - Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor

T2 - SOLUSION Trial

AU - Azawi, Nessn

AU - Vásquez, Juan Luis

AU - Dreyer, Thomas

AU - Guldhammer, Cathrine Silberg

AU - Saber Al-Juboori, Rami Muthanna

AU - Nielsen, Anna Munk

AU - Jensen, Jørgen Bjerggaard

N1 - Publisher Copyright: © 2023 by the authors.

PY - 2023

Y1 - 2023

N2 - Background: The surveillance of non-muscle invasive bladder cancer (NMIBC) requires frequent cystoscopies, which are costly and uncomfortable for patients. Uromonitor is a validated non-invasive urinary test for detecting NMIBC recurrence. However, data on its clinical benefit in an NMIBC surveillance program is limited. Objective: To assess the diagnostic accuracy of Uromonitor in NMIBC surveillance and its potential to limit the number of cystoscopies. Design, Setting, and Participants: The study included 202 patients with previous low-grade (LG) NMIBC tumors. Newly diagnosed patients were scheduled for flexible cystoscopy and Uromonitor test at 4, 12, and 24 months from the time of diagnosis. Patients with tumors diagnosed before entering the study underwent cystoscopy and Uromonitor test at the start of the study and 12 and 24 months from inclusion in the study. Outcome Measurements and Statistical Analysis: Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV). Results and Limitations: Between February 2020 and October 2022, 202 patients were enrolled in the study. Of these patients, 171 met the eligibility criteria to perform the analysis, with a median age of 69 years, IQR (62–74), and 380 flexible cystoscopies with simultaneous Uromonitor tests. Overall, 39/171 (22.8%) patients had recurrences. Uromonitor showed a sensitivity of 89.7%, specificity of 96.2%, PPV of 72.9%, and NPV of 98.8%. In 28 cases, flexible cystoscopy was falsely positive, leading to surgery, where Uromonitor showed negative results. There were 13 cases of possible false positives for Uromonitor where flexible cystoscopy was negative. Conclusions: Uromonitor displays high diagnostic accuracy in detecting NMIBC recurrence with the potential for reducing the number of flexible cystoscopies in the follow-up of low- and intermediate-risk NMIBC. Patient Summary: We followed up on newly and previously diagnosed patients with LG NMIBC. We concluded that Uromonitor could potentially reduce the number of cystoscopies in NMIBC surveillance programs.

AB - Background: The surveillance of non-muscle invasive bladder cancer (NMIBC) requires frequent cystoscopies, which are costly and uncomfortable for patients. Uromonitor is a validated non-invasive urinary test for detecting NMIBC recurrence. However, data on its clinical benefit in an NMIBC surveillance program is limited. Objective: To assess the diagnostic accuracy of Uromonitor in NMIBC surveillance and its potential to limit the number of cystoscopies. Design, Setting, and Participants: The study included 202 patients with previous low-grade (LG) NMIBC tumors. Newly diagnosed patients were scheduled for flexible cystoscopy and Uromonitor test at 4, 12, and 24 months from the time of diagnosis. Patients with tumors diagnosed before entering the study underwent cystoscopy and Uromonitor test at the start of the study and 12 and 24 months from inclusion in the study. Outcome Measurements and Statistical Analysis: Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV). Results and Limitations: Between February 2020 and October 2022, 202 patients were enrolled in the study. Of these patients, 171 met the eligibility criteria to perform the analysis, with a median age of 69 years, IQR (62–74), and 380 flexible cystoscopies with simultaneous Uromonitor tests. Overall, 39/171 (22.8%) patients had recurrences. Uromonitor showed a sensitivity of 89.7%, specificity of 96.2%, PPV of 72.9%, and NPV of 98.8%. In 28 cases, flexible cystoscopy was falsely positive, leading to surgery, where Uromonitor showed negative results. There were 13 cases of possible false positives for Uromonitor where flexible cystoscopy was negative. Conclusions: Uromonitor displays high diagnostic accuracy in detecting NMIBC recurrence with the potential for reducing the number of flexible cystoscopies in the follow-up of low- and intermediate-risk NMIBC. Patient Summary: We followed up on newly and previously diagnosed patients with LG NMIBC. We concluded that Uromonitor could potentially reduce the number of cystoscopies in NMIBC surveillance programs.

KW - follow-up cystoscopy

KW - low-grade recurrence

KW - non-muscle invasive bladder cancer

KW - surveillance

KW - urinary test

KW - Uromonitor

U2 - 10.3390/cancers15082341

DO - 10.3390/cancers15082341

M3 - Journal article

C2 - 37190269

AN - SCOPUS:85153877168

VL - 15

JO - Cancers

JF - Cancers

SN - 2072-6694

IS - 8

M1 - 2341

ER -