Symptom-guided reduction of BCG dwell time: findings from the north-REG randomized trial
In brief
Symptom-guided BCG dwell-time cuts urgency by up to one-third and halves systemic side effects
In a trial of 225 NMIBC patients, shortening BCG dwell time to 60 or 30 minutes when symptoms rose lowered urgency from 47% to 34% at week 3 and from 49% to 32% at week 6, and reduced systemic symptoms during maintenance from 61% to 30% and fatigue from 47% to 22%. Completion rates were unchanged, suggesting personalized dwell-time improves tolerability without compromising treatment adherence.
- Journal
- BJU international (Q1)
- Published
- 31 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Lene Munk, Josephine Maria Hyldgaard, Vanaja Kumasegaram, Rikke Vilsbøl Milling, Simone Buchardt Brandt, Juan Luis Vásquez, et al.
- PMID
- 42538302
- DOI
- 10.1111/bju.70396
Why clinicians should know about it
- Picked for Urology (top studies of the week, 2 August 2026): Symptom‑guided BCG dwell‑time reductions lower urgency and toxicity
Abstract
OBJECTIVES: To 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). METHODS: Within 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. RESULTS: At 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. CONCLUSION: Daily 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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.