Flexible cystoscopy is often associated with discomfort, particularly during passage through the external urethral sphincter. Various interventions have been trialled to reduce procedural pain. While the manual “bag-squeeze” method has been endorsed by the EAU Guidelines due to its analgesic effect, it introduces variability in pressure delivery. This study aims to evaluate a pressure bag system as a controlled, reproducible method of irrigation and compare its efficacy in reducing procedural pain to existing techniques.

This prospective, randomised, double-blinded controlled trial was conducted at Westmead Hospital. Eligible male patients (>18 years) undergoing routine flexible cystoscopy were randomised into three groups: Gravity irrigation (current standard), Manual bag-squeeze (EAU-endorsed), Pressure bag set to 350mmHg (proposed intervention). Patients and proceduralists were blinded to irrigation type (manual and pressure bag). Exclusion criteria included prior complications, additional concurrent procedures, and recent analgesia use. Pain was assessed using a Visual Analogue Scale (VAS). Secondary outcomes included PROMIS pain/anxiety scores at 7 days and complication rates within 30 days.

Interim analysis showed no statistically significant difference between gravity and bag-squeeze groups (mean difference: 0.0, 95% CI [-0.9 to 0.9]), nor between gravity and pressure bag (0.7, 95% CI [-0.1 to 1.5]). However, pressure bag irrigation demonstrated a statistically significant reduction in mean VAS pain scores compared to the bag-squeeze method (-0.7, 95% CI [-1.4 to -0.01]). Patient follow-up at 30 days for complications was limited, impacting assessment of safety outcomes.

Preliminary findings suggest that pressure bag irrigation may offer superior pain reduction compared to current gold standard bag-squeeze irrigation during flexible cystoscopy. The pressure bag method also provides consistent, reproducible flow rates and reduces operator-dependent variability. This low-cost, easily implementable approach could enhance patient comfort. Ongoing data collection and potential multi-centre expansion are planned to strengthen findings and evaluate longer-term outcomes.