Evidence map›Paper›PMID 40048558›Full record

Trial reportThe Journal of urology2025

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.

Angela M Stover, Dana Mueller, Jessica Carda-Auten, Alison Hilton, Victoria Tsurutis, Angela B Smith

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

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. An erratum has been issued. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT05243550 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorUroGen Pharma Ltd.Ran2022 to 2028Enrolled240ConditionsBladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma BladderArmsUGN-102
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Editorial Comment.The Journal of urology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Angela M StoverDepartment of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.ORCID 0000-0003-0983-686X
Dana MuellerDepartment of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Jessica Carda-AutenLineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
Alison HiltonLineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
Victoria TsurutisUroGen Pharma, Ltd, Princeton, New Jersey.
Angela B SmithLineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Venkata Saroja Voruganti · 1999 to 2026
$31.6M
NCI NIH HHS P30 CA016086NIDDK NIH HHS P30 DK056350
6 · The paper itself

Abstract

purposeAdults with low-grade intermediate-risk nonmuscle-invasive bladder cancer commonly ask urologists how their routine/responsibilities will be affected by treatments, including the standard of care, transurethral resection of bladder tumor (TURBT). We asked patients in the ENVISION trial to compare TURBT with a nonsurgical primary treatment (UGN-102 containing mitomycin) for acceptability and impact on their routine/responsibilities. MATERIALS AND

methodsENVISION is a phase 3, single-arm trial where UGN-102 was administered as 6 weekly intravesical instillations. Interviews with US patients were conducted at enrollment (before instillations) and 3 months (primary trial end point). Transcripts were coded by 3 coders using the gold standard of content analysis to derive interview themes.

resultsForty-one US patients from 31 sites were eligible, and 29 of 41 completed both interviews. Most of the participating patients were male (62%), White (83%), and of age 65+ years (69%). Three themes were derived: (1) Patients perceived that TURBT interfered more with their routine/responsibilities. (2) Urinary symptoms were perceived to be similar, but bleeding, catheter issues, and time to resuming sexual activity lasted longer with TURBT. For UGN-102, uncommon reports were internal itching and difficulty keeping gel in the bladder during instillations. (3) Patients would recommend UGN-102 to other patients because it was perceived to be less invasive, painful, and time-consuming than TURBT.

conclusionsPatients perceived UGN-102 to be a favorable primary treatment alternative to traditional surgical resections for low-grade intermediate-risk nonmuscle-invasive bladder cancer. By focusing on the underexplored area of patient perceptions, this study provides key information urologists will need to conduct shared decision-making conversations.

trial registrationClinicalTrials.gov Identifier: NCT05243550.

Indexed as

Antibiotics, AntineoplasticCystectomyMitomycinNeoplasm Recurrence, LocalNon-Muscle Invasive Bladder NeoplasmsAdministration, IntravesicalAgedDrug CombinationsFemaleHumansMaleMiddle AgedNeoplasm GradingAntibiotics, AntineoplasticDrug CombinationsMitomycinclinical trialdrug-related side effectsintravesicalNMIBC neoplasmsurinary bladder diseases

Identifiers

PMID40048558
PMCPMC12708022

What OpenQuestion holds

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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.