Patient experiences with UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC): Insights for shared decision making.

Abstract

4602 Background: Recurrent LG-IR-NMIBC can be managed using various approaches, including repeat transurethral resection of bladder tumor (TURBT) and non-surgical intravesical therapies. One option is UGN-102, a reverse thermal hydrogel containing 75mg mitomycin. Given LG-IR-NMIBC tends to recur, understanding patients’ experiences/preferences across management strategies is essential to support clinical shared decision making. Methods: The ENVISION study (NCT05243550) assessed patient-reported outcomes via EORTC-QLQ-NMIBC24. Patients with biopsy-confirmed LG-IR-NMIBC and ≥1 previous NMIBC episode at baseline had 6 once-weekly intravesical instillations of UGN-102 in an outpatient setting. 32 US-based patients had semi-structured prospective phone interviews that compared experiences of prior TURBT (at enrollment) vs UGN-102 at 3 months. Results: 232 patients were included; 94.8% received all 6 doses of UGN-102. Mean change from baseline (CfB) scores at 3- and 12-months post-treatment did not reach minimal clinically important difference (MCID) thresholds for any of the EORTC-QLQ-NMIBC24 domains (Table). Patients perceived more interference with routines/responsibilities with TURBT vs UGN-102, similar urinary symptoms, expressed concern regarding more bleeding with TURBT, and would recommend UGN-102 as a less invasive, painful, and time-consuming procedure than TURBT. A small number of patients preferred surgery as a 1-day procedure vs 6 weekly intravesical instillations. Conclusions: UGN-102 maintained stable quality-of-life scores across NMIBC24 domains and was generally preferred by patients over surgical resections. These important insights support shared decision making, enabling clinicians to discuss trade-offs between procedural convenience and treatment invasiveness in recurrent LG-IR-NMIBC management. Clinical trial information: NCT05243550 . EORTC-QLQ-NMIBC24 domain MCID Baseline, mean (SD) n 3-month CfB, mean (SD) n 12-month CfB, mean (SD) n Urinary symptoms 6.34 13.7 (14.50) 231 0.8 (13.30) 217 −0.6 (10.71) 154 Malaise 4.37 4.0 (8.79) 231 0.2 (10.57) 217 1.2 (9.55) 154 Intravesical treatment issues 9.38 12.8 (18.74) 231 −0.8 (20.14) 217 0.2 (20.34) 154 Future worries 11.08 35.6 (22.49) 231 −4.1 (21.71) 217 −7.1 (22.84) 154 Bloating and flatulence 7.59 9.2 (15.35) 231 1.1 (16.24) 217 0.8 (15.52) 154 Risk of contaminating partner 13.66 10.9 (23.74) 141 −1.6 (17.45) 106 −7.5 (20.78) 67 Female sexual problems 12.87 9.6 (22.04) 45 −2.1 (18.81) 32 −3.5 (15.29) 19 Male sexual problems 16.29 21.9 (32.77) 144 1.2 (23.71) 134 0 (26.89) 94 Sexual intimacy 8.69 8.0 (17.27) 142 1.3 (22.35) 103 2.9 (20.55) 68 Sexual function 10.61 79.4 (25.01) 231 4.0 (15.25) 218 4.1 (16.97) 154 Sexual enjoyment 11.64 60.5 (33.11) 140 8.0 (25.23) 104 10.4 (29.71) 67 SD, standard deviation. A positive CfB indicates worsening across all scales/items.