Solifenacin to relieve ureteral stent-related symptoms: A randomized, double-blinded placebo-controlled study

Ureteral stents have been an important tool in ureteral procedures. However, indwelling ureteral stents produce varying degrees of complications and discomfort. Although manufacturers have responded with novel stent shapes, materials and drug coatings, no ideal stent has been designed to date that significantly improves these complications. Many investigators have attempted to improve stent-related symptoms by using various agents, including oral anticholinergics. However, the roles of these medications in the treatment of ureteral stent-related symptoms remained unclear. We therefore propose to conduct a randomized, placebo-controlled study to evaluate the possible role of the antimuscarinics Solifenacin for improving stent-related symptoms after ureteroscopic procedures. The study is designed as a prospective, randomized, double blind, placebo- controlled trial. From 01/10/2010 to 30/09/2011, all patients with unilateral ureteral stones or stricture to be treated with ureteroscopy where temporary stenting is indicated will be considered for enrollment in the study. Patients will be randomly assigned in a concealed fashion to 1 of 2 groups. In group 1 (placebo group), patients will receive placebo orally once daily for two weeks. In group 2, patients will receive Solifenacin 10 mg orally once daily for two weeks. Randomization will be performed in a 1:1 ratio. Investigators and patients will be blinded to the randomization scheme and investigators will be blinded to the medication until study termination. We estimated 100 patients will be enrolled in this study. Semirigid ureteroscopy will be performed in all patients using a Wolf 6Fr/7.5Fr dual operating channel semirigid ureteroscope to passively dilate the ureteral orifice and address distal ureteral pathology. Intracorporeal lithotripsy will be performed using a 0.8 J 10 Hz holmium laser. All stents will be placed under ureteroscopic guidance. Ureteral stent-related symptoms will be measured at various time points via telephone interview by using a 10-cm linear visual analogue scale (VAS) for evaluating suprapubic pain and voiding flank pain, and irritative domain of International Prostate Symptom Scale (IPSS), in which 0 represented no pain and 10 represented extreme pain. Patients will be asked to complete the questionnaires on postoperative day 1, day 3, and on the day of stent removal. The median absolute symptom and VAS scores will be compared for each group at each time point. The primary outcome measure will be the assessment of the difference in ureteral stent symptoms in the treatment group compared with the placebo group. Statistical analysis will be performed with computer software.