A Phase III, Multicenter, Randomized, Controlled, Double-Blind Study Comparing the Efficacy and Safety of High-Dose (4%) versus Standard (2%) Lidocaine Gel for Local Anesthesia in Transurethral Procedures

Placement or exchange of double-J (DJ) ureteral stent

Intraoperative pain intensity, defined as the participant’s strongest procedure-related pain experienced during placement or exchange of the DJ ureteral stent, assessed retrospectively within 5 minutes after completion of the transurethral procedure using a 100 mm VAS (Day 1).

Postoperative pain intensity, assessed using a 100 mm VAS, 1 hour after placement or exchange of DJ ureteral stent (Day 1)., Participant-reported acceptability of the current procedure-related symptom state assessed using the Patient Acceptable Symptom State (PASS) question, within 5 minutes after placement or exchange of DJ ureteral stent (Day 1)., Participant-reported acceptability of the current procedure-related symptom state assessed using the PASS question, 1 hour after placement or exchange of DJ ureteral stent (Day 1)., Procedure duration, defined as the time (in minutes) from cystoscope insertion to completion of DJ ureteral stent placement or exchange, recorded by the Physician (Day 1)., Physician’s global assessment of procedural ease, assessed using a 5-point Likert rating scale (1 = very difficult to 5 = very easy), within 5 minutes after placement or exchange of DJ ureteral stent (Day 1)., Incidence, seriousness and causality of AEs., Change from baseline in vital signs.

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