Impact of Patient‐Controlled Bag Squeeze on Pain and Anxiety in Male Patients Undergoing Flexible Cystoscopy: A Double‐Blind Randomized Control Study

INTRODUCTION: The aim of this randomized control trial is to evaluate the effect of patient-controlled irrigation on pain and anxiety during outpatient flexible cystoscopy in male patients. MATERIALS AND METHODS: From April to June 2025, a prospective, double-blind randomized controlled trial was conducted. Male outpatients undergoing diagnostic flexible cystoscopy were randomly allocated to either squeeze a functioning water bag connected to the irrigation system (patient-controlled bag squeeze group) or a disconnected sham bag (standard irrigation group). The primary outcome was Visual Analogue Scale for pain. Secondary outcomes included changes in the State-Trait Anxiety Inventory, Visual Analogue Scale for satisfaction, physiological metrics, and patient preference regarding self-involvement in bag squeezing. RESULTS: A total of 50 patients were randomized to the patient-controlled bag squeeze (n = 24) or standard irrigation (n = 26) group. Baseline characteristics were similar between groups. The patient-controlled bag squeeze group demonstrated significantly higher irrigation volume and flow rate, with no difference in procedure duration. Pain scores were significantly lower (p = 0.0001) and satisfaction scores higher (p = 0.006) in the patient-controlled bag squeeze group. A significantly greater proportion of patients in the patient-controlled bag squeeze group reported a favorable preference for the intervention (p = 0.002). No differences were seen in physiological measures or anxiety reduction, and no infections occurred. CONCLUSIONS: Patient-controlled bag squeeze appears to be a safe and effective analgesia method comparable to caregiver-assisted methods, and demonstrates favorable patient preference. TRIAL REGISTRATION: University Hospital Medical Information Network clinical trials registry, Japan: UMIN000057485.