Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial
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 surveillan...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-04-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/15/8/2341 |
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| author | Nessn Azawi Juan Luis Vásquez Thomas Dreyer Cathrine Silberg Guldhammer Rami Muthanna Saber Al-Juboori Anna Munk Nielsen Jørgen Bjerggaard Jensen |
| author_facet | Nessn Azawi Juan Luis Vásquez Thomas Dreyer Cathrine Silberg Guldhammer Rami Muthanna Saber Al-Juboori Anna Munk Nielsen Jørgen Bjerggaard Jensen |
| author_sort | Nessn Azawi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T05:10:30Z |
| format | Article |
| id | doaj.art-d7e85f80a02e43feb381f16a53b60bba |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-11T05:10:30Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-d7e85f80a02e43feb381f16a53b60bba2023-11-17T18:39:38ZengMDPI AGCancers2072-66942023-04-01158234110.3390/cancers15082341Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION TrialNessn Azawi0Juan Luis Vásquez1Thomas Dreyer2Cathrine Silberg Guldhammer3Rami Muthanna Saber Al-Juboori4Anna Munk Nielsen5Jørgen Bjerggaard Jensen6Department of Urology, Zealand University Hospital, Sygehusvej 6, 4000 Roskilde, DenmarkDepartment of Urology, Zealand University Hospital, Sygehusvej 6, 4000 Roskilde, DenmarkDepartment of Urology, Arhus University Hospital, 8200 Aarhus, DenmarkDepartment of Urology, Zealand University Hospital, Sygehusvej 6, 4000 Roskilde, DenmarkDepartment of Urology, Zealand University Hospital, Sygehusvej 6, 4000 Roskilde, DenmarkDepartment of Urology, Arhus University Hospital, 8200 Aarhus, DenmarkDepartment of Urology, Arhus University Hospital, 8200 Aarhus, DenmarkBackground: 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.https://www.mdpi.com/2072-6694/15/8/2341non-muscle invasive bladder cancerUromonitor<sup>®</sup>urinary testsurveillancefollow-up cystoscopylow-grade recurrence |
| spellingShingle | Nessn Azawi Juan Luis Vásquez Thomas Dreyer Cathrine Silberg Guldhammer Rami Muthanna Saber Al-Juboori Anna Munk Nielsen Jørgen Bjerggaard Jensen Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial Cancers non-muscle invasive bladder cancer Uromonitor<sup>®</sup> urinary test surveillance follow-up cystoscopy low-grade recurrence |
| title | Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial |
| title_full | Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial |
| title_fullStr | Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial |
| title_full_unstemmed | Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial |
| title_short | Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial |
| title_sort | surveillance of low grade non muscle invasive bladder tumors using uromonitor solusion trial |
| topic | non-muscle invasive bladder cancer Uromonitor<sup>®</sup> urinary test surveillance follow-up cystoscopy low-grade recurrence |
| url | https://www.mdpi.com/2072-6694/15/8/2341 |
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