Efficacy of tamsulosin hydrochloride in relieving "double-J ureteral stent-related morbidity": a randomized placebo controlled clinical study.

OBJECTIVES: To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ, IPSS, QOL and VAS (primary objective) and to evaluate the morbidity and or complication(s) associated with indwelling double-J ureteral stent(s) and to evaluate the safety of tamsulosin therapy for "morbidity associated with double-J stents" by evaluating its tolerability, side effects and adverse events if any (secondary objective) as per protocol.

METHODS: After institutional review board approval, 60 consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin 0.4 mg, or a placebo for 4 weeks. The validated USSQ, VAS and IPSS were completed before stent insertion, at 3 days and 4 weeks after stent insertion and at 2 weeks after stent removal. Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test, Mann-Whitney test and Student's t test.

RESULTS: Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score, pain index score, work performance score, VAS score at loin area, VAS score at flank, VAS score at suprapubic area, average VAS score, need for antibiotics, number of hospital visits (P < 0.05) at the end of fourth weeks. Decrease in values were also observed in IPSS score, general health score, quality of sex score and IPSS-quality of life (QOL) score in patients taking tamsulosin but, however, the decrease was not significant. No patients discontinued medication because of side effects.

CONCLUSION: We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated, safe, effective and significantly beneficial in reducing stent morbidity in the majority of our patients. We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity.