A double-blind, randomized, placebo-controlled study to evaluate the efficacy of Oxybutynin Chloride Extended-Release tablets on the double-J stent related symptoms following uncomplicated ureteroscopic lithotripsy.

Abstract

To evaluate the effects of Oxybutynin Chloride Extended-Release Tablets (Oxbu) on double-J stent-related symptoms following uncomplicated ureterosocpic lithotripsy (URSL). This is a double-blind, randomized, placebo-controlled study with a total of 120 subjects with ureteral calculi receiving double-J stent insertion following URSL. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to Oxbu or placebo group. All patients completed a structured questionnaire assessing the stent-related symptoms one week after operation. The clinical data and stent characteristics were recorded as well. The severity of stent-related symptoms was compared between two groups. The mean age were 58.2 years both in Oxbu group and control group, and the demographic data were all comparable between the two groups. Oxbu group had significant improvement for stent related pain score (-0.47 points, P < 0.01) and quality of life score (-0.17 points, P < 0.01) compared to the control group. The male subgroup showed that Oxbu had less urgency item score (-0.59 points, P < 0.05). The subgroup analysis for female showed that Oxbu had more decrease in the intermittency item score (-0.89 points, P = 0.043) and aged < 50 showed Oxbu had more decrease in Overactive Bladder Symptoms Score total score and urgency item score (-0.8 and - 0.6 points, all P < 0.05). This study showed that Oxbu decreases the severity of double-J stent related pain and the quality of life score for patients received URSL. In the IPSS and OABSS item, the intermittency and urgency are improved in the Oxbu group. In conclusion, Oxbu treatment had beneficial effects to improve the severity of stent related symptoms.