Innovation: Reshaping the NMIBC Care Continuum

NMIBC is often defined by repeated cycles of evaluation, recurrence, and intervention that can span many years. Improving outcomes for patients requires more than a single therapeutic breakthrough—it requires progress across the entire disease management pathway. Today, advances in detection, diagnosis, surveillance, and treatment are collectively reshaping how NMIBC is managed and monitored.1-3

Key Areas of Progress in NMIBC Care

Icon of magnifying glass looking at a gear, indicating improved detection and diagnostic tools in NMIBC

Innovation across the care pathway: Advances in NMIBC management are occurring across multiple stages of care—from improved detection and diagnostic tools to evolving surveillance strategies and new therapeutic options.1-3

Compass icon reflecting NMIBC care developments in 4 directions: visualization, pathology, surveillance, and therapy

A more coordinated approach to progress: Together, these developments reflect a broader shift in NMIBC care. Improvements in visualization, pathology, surveillance, and therapy are working in concert to improve outcomes and support more personalized, patient-centered approaches to disease management.1-3

Enhancing Visualization in NMIBC Detection

Accurate visualization is critical to detecting bladder tumors and achieving a complete resection during transurethral resection of bladder tumor (TURBT). While white-light cystoscopy remains the standard approach, enhanced visualization technologies are helping clinicians identify lesions that may otherwise be difficult to detect.4

Limited: White-light Cystoscopy (WLC)
  • Current gold standard for visualizing bladder tumors during diagnosis and TURBT5
  • Tumor morphology can vary widely, making some lesions difficult to detect1
  • Flat lesions, particularly carcinoma in situ (CIS), may be harder to visualize1
  • Up to 20% of lesions may be missed with WLC alone5
Enhanced: Blue-light Cystoscopy (BLC)
  • Also known as fluorescence cystoscopy or photodynamic diagnosis5
  • Enhances visualization of bladder tumors during cystoscopy5
  • Improves detection of lesions not visible with white light5
  • In a phase 3 study, 21% of intermediate or high-risk NMIBC tumors were identified only via BLC5
Enhanced: Narrow Band Imaging (NBI)
  • Improves the visualization of small, flat, or otherwise difficult-to-detect lesions6-7
  • No specialist equipment required, or dye instillation8
Improved detection can enable more complete tumor resection and may reduce residual disease and recurrence following TURBT
A team of uro-uncologists gathered around a laptop screen, reviewing non-muscle-invasive bladder cancer pathology results  Not an actual physician interaction.

The Central Role of Pathology in NMIBC Care

Accurate pathology is foundational to NMIBC management. Pathologic evaluation informs tumor staging, grading, and risk stratification—factors that directly influence treatment selection, surveillance intensity, and eligibility for certain therapies.1,10

However, assessing clinical and pathologic features can involve a degree of interpretation, subjectivity, and variability between pathologists, which can affect diagnostic consistency. Inaccurate initial pathology results may lead to differences in staging or grading, which can influence the treatment path or restrict access to potentially impactful treatments.11,12

Supporting Pathologists with AI-assisted Analysis

By providing additional analytical insights, AI-assisted tools may help improve diagnostic consistency and strengthen the accuracy of risk stratification used in clinical decision-making.13

AI is emerging as a tool to:

  • Help improve the reproducibility and consistency of pathological evaluation
  • Analyze complex tissue patterns, segment regions of interest, and identify neoplastic areas
  • Assist with grading and staging assessments of bladder cancer specimens
The goal of these technologies is to support existing practices and enable more informed decisions13

Moving Beyond Traditional Cytology

Although cystoscopy remains the gold-standard tool for surveillance in NMIBC,4 evolving developments in cytology may soon help complement or even reduce the frequency of cystoscopy-based surveillance.1 This could minimize the negative impact of invasive surveillance on patient quality of life.14

Newer biomarker tests (such as NMP22 or BTA) or more advanced genetic and epigenetic panels may improve test sensitivity.4

Enhanced image of a bladder cell as if under a microscope to indicate better detection of non-muscle-invasive bladder cancer
Image of a uro-uncologist’s gloved hands scanning a urinary biomarker test to help detect non-muscle-invasive bladder cancer

Increasing Sensitivity of Urine Testing with Biomarkers

Developments in cytology have yielded several FDA-approved approaches to improve detection sensitivity. These approaches are less like traditional cytology and more like liquid biopsy and biomarker testing.15 Currently available FDA-approved urinary biomarker tests demonstrate sensitivities in the range of ~60%–80%, while newer genomic assays under development are approaching sensitivities greater than 90%.1

As these technologies continue to evolve, they may help clinicians detect disease recurrence earlier and potentially complement, or in some cases reduce, the frequency of cystoscopy-based surveillance—minimizing the impact to patient quality of life from invasive disease surveillance.

Exploring New Approaches in Intravesical Therapy

Intravesical therapies can be effective in NMIBC but may be limited by the bladder environment itself. Because these treatments are delivered directly into the bladder, dwell time can be short, and passive diffusion and dilution may reduce urothelial exposure to therapeutic agents, potentially limiting antitumor activity.16,17

Emerging treatment strategies are expanding bladder-preserving options by improving both the delivery and the mechanism of action of intravesical therapies.3

  • Novel drug-delivery systems are being developed to increase the residence time of intravesical therapies within the bladder. Sustained-release devices, for example, use semi-permeable materials to release medication osmotically over several weeks, helping improve local drug retention and urothelial exposure
  • Other approaches explore ways to increase bladder permeability, which may enhance the penetration and retention of therapeutic agents within the urothelium
  • Studies evaluating these strategies are beginning to show promise in patients with NMIBC
Over time, emerging technologies may help extend recurrence-free intervals and reduce the need for repeat intervention3
References: 1. Holzbeierlein J, Chang SS, James AC, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;1-50. 2. Comparat E, Amin MB, Cathomas R, et al. Current best practice for bladder cancer: a narrative review of diagnostics and treatments. Lancet. 2022;400(10364):1712-1721. 3. Ghodoussipour S, Bivalacqua T, Bryan RT, et al. A systematic review of novel intravesical approaches for the treatment of patients with non-muscle invasive bladder cancer. Eur Urol. 2025;88:33-35. 4. Gontero P, Comperat AB, Dominguez Escrig JL, et al. EAU guidelines on non-muscle-invasive bladder cancer (TaT1 and CIS). Eur Urol. Presented at EAU Annual Congress 2025; Madrid, Spain. 5. Lotan Y, Bivalacqua TJ, Downs T, et al. Blue light flexible cystoscopy with hexaminolevulinate in non-muscle-invasive bladder cancer: a review of the clinical evidence and consensus statement on optimal use in the USA—update 2018. Nat Rev Urol. 2019;16:377-386. 6. Hsueh TY, Chiu AW. Narrow band imaging for bladder cancer. Asian J Urol. 2016;3:126-129. 7. National Cancer Institute website. Accessed April 5, 2026. http://cancer.gov/types/bladder/stages 8. Tatsugami K, Kuroiwa K, Kamoto T, et al. Evaluation of narrow band imaging as a complementary method for the detection of bladder cancer. J Endourol. 2010;11:1807. 9. Russo GI, Sholklapper TN, Cocci A, et al. Performance of narrow band imaging (NBI) and photodynamic diagnosis (PDD) fluorescence imaging compared to white light cystoscopy (WLC) in detecting non-muscle invasive bladder cancer: a systematic review and lesion-level diagnostic meta-analysis. Cancers. 2021;13(17):4378. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer. V.1.2026. National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed April 5, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. 11. Jordan B, Meeks JJ. T1 bladder cancer: current considerations for diagnosis and management. Nat Rev Urol. 2019;16(1):23-34. 12. Giunchi F, Panzacchi R, Capizzi E, et al. Role of inter-observer variability and quantification of muscularis propria in the pathological staging of bladder cancer. Clin Genitourin Cancer. 2016;14(4):e307-312. 13. Khoraminia F, Fuster S, Kanwal N, et al. Artificial intelligence in digital pathology for bladder cancer: hype or hope? A systematic review. Cancers. 2023;15:4518. 14. Tan WS, Teo CH, Chan D, et al. Mixed-methods approach to exploring patients’ perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance. BJU Int. 2019;124:408-417. 15. Ng K, Stenzl A, Sharma A, et al. Urinary biomarkers in bladder cancer: a review of the current landscape and future directions. Urol Oncol. 2021;39(1):41-51. 16. Maffezzini M, Campodonico F, Puntoni M, et al. Systemic absorption and pharmacokinetics of single-dose intravesical gemcitabine after transurethral resection of the bladder in non-muscle-invasive bladder cancer. Urology. 2009;74:1078-1084. 17. Daneshmand S, Van der Heijden MS, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin–unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025;43(33):3578-3588.
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