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

Abstract

Purpose: Adults 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 methods: ENVISION 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.

Results: Forty-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.

Conclusions: Patients 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 registration: ClinicalTrials.gov Identifier: NCT05243550.

Keywords: NMIBC neoplasms; clinical trial; drug-related side effects; intravesical; urinary bladder diseases.

Figure.

Visual abstract.

Figure.

Data flow for US interviews in the ENVISION phase 3 trial.