Trial reportBJU international2026
Symptom-guided reduction of BCG dwell time: findings from the north-REG randomized trial.
Trial report in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04701151 (Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC), which is not on this map. Not yet cited in PubMed.
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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
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Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
Who cites it
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Authors and funding
16 authors.
Funding
Abstract
objectivesTo evaluate the impact of personalized dwell-time (DT) reductions on symptom prevalence and systemic toxicities in patients undergoing Bacillus Calmette-Guérin (BCG) instillation for non-muscle invasive bladder cancer (NMIBC).
methodsWithin a multinational randomized controlled trial (North-REG Dwell Time Study [NCT04701151]), 225 patients provided daily electronic patient-reported outcomes data during BCG induction and maintenance cycles. Participants were randomized 1:1, stratified by clinical site, sex, and concomitant carcinoma in situ, to either a standard care arm (control) or an intervention arm. Toxicity was analysed using a 'worst-day' principle to capture peak symptom burden. All patients initially received a standard 120-min DT. In the intervention group, algorithm-guided DT reductions (to 60 or 30 min) were triggered by real-time symptom severity, whereas the control group maintained a 120-min DT.
resultsAt baseline, 69% vs. 71% (control vs. intervention) of participants reported pre-existing symptoms, primarily lower urinary tract symptoms such as pollakiuria and urgency. During induction, the intervention group experienced significantly lower rates of urgency at week 3 (34% vs. 47%, P = 0.04) and week 6 (32% vs. 49%, P = 0.01). Significant reductions were also observed during maintenance at week 9 for systemic symptoms (30% vs. 61%, P < 0.001) and fatigue (22% vs. 47%, P = 0.001). Total adherence to the 15-instillation protocol was 38% in the intervention group and 40% in the control group.
conclusionDaily electronic patient-reported outcomes monitoring revealed that patients with NMIBC have a high baseline symptom burden prior to BCG therapy. Symptom-guided DT reductions may reduce local urgency and systemic toxicity and improve treatment tolerability. However, treatment completion does not seem to be affected.
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