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Related Concept Videos

Urinary Tract Calculi III: Medical Management01:30

Urinary Tract Calculi III: Medical Management

23
The diagnosis of renal calculi involves several imaging techniques, including non-contrast CT scans and ultrasound. These methods help visualize kidney stones, assess their size and location, and detect possible obstructions. Additionally, Measuring urine pH is useful for diagnosing specific stone types, such as struvite (alkaline pH) and uric acid stones (acidic pH). Cystine stones are primarily linked to cystinuria, a genetic condition. A urinalysis helps detect blood in the urine (hematuria)...
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Urinary Tract Calculi VI: Surgical Management01:25

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Procedures for Kidney StonesMedical intervention is necessary when kidney stones or renal calculi are too large to pass spontaneously (typically greater than 5 millimeters) when stones are accompanied by symptomatic infection (such as fever or pyelonephritis), when they impair kidney function, or when they cause persistent symptoms like severe pain, nausea, or urinary retention. Additionally, patients with only one kidney or those who cannot be treated with medical management also require...
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Related Experiment Video

Updated: Sep 9, 2025

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Mitomycin Intravesical Solution: First Approval.

Susan J Keam1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. cdi@adis.com.

Clinical Drug Investigation
|August 31, 2025
PubMed
Summary
This summary is machine-generated.

ZUSDURI™, a novel hydrogel mitomycin formulation, is now approved in the USA for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) via intravesical instillation.

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Area of Science:

  • Oncology
  • Urology
  • Drug Development

Background:

  • Non-muscle invasive bladder cancer (NMIBC) requires effective intravesical treatments.
  • Low-grade intermediate-risk NMIBC (LG-IR-NMIBC) presents specific treatment challenges.
  • Existing treatments for LG-IR-NMIBC have limitations, necessitating novel approaches.

Purpose of the Study:

  • To summarize the development milestones of mitomycin intravesical solution (ZUSDURI™).
  • To highlight the journey leading to the FDA approval for LG-IR-NMIBC treatment.
  • To provide an overview of this new therapeutic option for bladder cancer.

Main Methods:

  • Review of development history and clinical data for mitomycin intravesical solution.
  • Analysis of regulatory submission and approval process.
  • Focus on the hydrogel formulation and intravesical instillation delivery method.

Main Results:

  • Mitomycin intravesical solution (ZUSDURI™) has been developed as a hydrogel formulation.
  • The U.S. FDA approved ZUSDURI™ in June 2025 for recurrent LG-IR-NMIBC.
  • This marks a significant advancement in intravesical therapy for this specific bladder cancer subtype.

Conclusions:

  • Mitomycin intravesical solution represents a significant advancement in bladder cancer treatment.
  • The hydrogel formulation offers a novel approach for intravesical drug delivery.
  • FDA approval signifies a new therapeutic option for patients with recurrent LG-IR-NMIBC.