Trial reportThe Journal of urology2025
Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).
Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05243550 (A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
Who cites it
24 citing papers in PubMed.
- UGN-102 for Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial.The Journal of urology · 2026Trial
- Pharmacokinetics of UGN‑102, an investigational mitomycin‑containing reverse thermal gel for the treatment of non-muscle invasive bladder cancer.Cancer chemotherapy and pharmacology · 2025Trial
- Perceived Impact on Patient Routines/Responsibilities for Surgery and a Nonsurgical Primary Treatment Option in Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: Findings From the ENVISION Phase 3 Trial.The Journal of urology · 2025Trial
- Diagnosis, evaluation, and management of patients with non-muscle invasive bladder cancer.Future science OA · 2026Review
- [Non-muscle-invasive urothelial carcinoma of the bladder: time for a de-escalation of treatment and aftercare].Urologie (Heidelberg, Germany) · 2026Review
- Early Efficacy and Exploratory Biomarker Data of Bel-sar in Patients with Intermediate-risk and High-risk Non-muscle-invasive Bladder Cancer.European urology open science · 2026Article
- FDA approval of mitomycin hydrogel (Zusduri): a new non-surgical era for non-muscle-invasive bladder cancer (NMIBC).Annals of medicine and surgery (2012) · 2026Article
- [Advances in intravesical therapy for nonZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026Review
- Clinical translation and landscape of stimuli-responsive nanomedicines and microscale therapeutics.Chemical Society reviews · 2026Review
- Functional hydrogel biomaterials for urological diagnosis and treatment-design strategies and application progress: a review.Journal of materials science. Materials in medicine · 2026Review
- STEAP2-associated modulation of PI3K/AKT/mTOR signaling contributes to ginkgetin-induced apoptosis in bladder cancer cells.Hereditas · 2026Article
- Use of Shared Decision-Making in Non-Muscle-Invasive Bladder Cancer: Protocol for a Scoping Review.JMIR research protocols · 2026Article
- Advances in the management of localized bladder cancers.Nature reviews. Clinical oncology · 2026Review
- Patient-Reported Outcomes Following UGN-102 Treatment in Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: An Analysis of 3 Clinical Trials.Urology practice · 2026Article
- Review
- Psychometric Validation of the QLQ-NMIBC24 in Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer.Research and reports in urology · 2026Article
- Real-world safety profile of mitomycin: signal detection and time-to-onset analysis from FDA adverse event reporting system and VigiAccess databases.International journal of clinical pharmacy · 2025Article
- Low-grade non-muscle-invasive bladder cancer: molecular landscape, treatment strategies and emerging therapies.Nature reviews. Urology · 2025Review
- Mitomycin Intravesical Solution: First Approval.Clinical drug investigation · 2025Review
- The Future of Bladder Cancer Therapies: Integrating Hydrogel Scaffolds for Epigenetic Regulator Delivery.Cureus · 2025Review
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer. MATERIALS AND
methodsENVISION is an ongoing, multinational, single-arm, phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR; negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future.
resultsOf 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (80%; 95% CI, 73.9-84.5) achieved CR at 3 months, with an 82% (95% CI, 75.9-87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, UTI, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%); 2 were treatment related (urinary retention/urethral stenosis), and both resolved.
conclusionsPrimary chemoablation with UGN-102 in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer resulted in an 80% CR rate. Patients achieving a CR had an 82% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a nonsurgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy.
trial registrationClinicalTrials.gov Identifier: NCT05243550.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.