The Role of Tadalafil in Lower Ureteric Stone Expulsion


ABSTRACT:BACKGROUND:The Recent Studies have reported outstanding results concerning medical expulsive therapy (MET) for distal ureterolithiasis in terms of stone expulsion and control of colic pain. While ureteral intracorporeal lithotripsy and extracorporeal shock wave lithotripsy are recognized to be effective.OBJECTIVE:To evaluate the role of phosphodiesterase 5 inhibitor (tadalafil) 10mg in conservative therapy for patients with lower ureteral stones.PATIENTS AND METHODS:From December 2009 to October 2010, 60 consecutive symptomatic patients with juxtavesical unilateral lower ureterolithiasis from the urologic consultation department in Baghdad Medical City were enrolled in this randomized prospective placebo controlled study (pilot study). Patients were randomly divided into two groups, group 1 (n=30) and group 2 (n=30). Group 1 was given tadalafil 10mg. Group 2 was given placebo. Tadalafil 10mg or placebo was administered once daily. The treatment duration was until stone expulsion or 14 days. During this period, all patients were evaluated weekly by US and serum creatinine level, and were asked whether they experienced acute colic pain, to score the intensity of pain according to a visual analog scale, whether the calculus passed spontaneously, the day and time of stone expulsion, number of analgesic use, and any drug side effects.RESULTS:The mean stone size was 7.91mm for treatment group and 7.55mm for placebo group (p> 0.05) .The stone expulsion rate was 93% for treatment group and 67% for placebo group (P<0.05). Mean expulsion time was 5.5 days for treatment group and 8.84 days for placebo group (P=0.001). Mean VAS was 3.9 for treatment group and 7.9 for placebo group (P<0.0001). Mean number of indomethacin suppositories used was 1.33 for treatment group and 7.9 for placebo group (P<0.05). The univariate analysis using Cox proportional hazard model revealed that only therapy and stone size proved to be significantly predictive factors of stone expulsion (P<0.0001 and 0.001) respectively, while gender and age did not have any predictive value. Although side-effects occurred more in patients who were given tadalafil 10mg, no significant side-effect was detected so as to require exclusion of a patient from the study.CONCLUSION:Medical Expulsive Therapy (MET) for lower ureterolithiasis with tadalafil during conservative treatment period is safe and effective as demonstrated by the absence of serious side effects and increased stone expulsion rate with early time. Also MET with tadalafil 10mg affords an outstanding control of pain for patients while waiting for stone expulsion.