ABSTRACT
The purpose of the work is to evaluate the effectiveness of Tamsulosin for patients with distal ureteral calculi with respect to its effect on stone expulsion and time to stone expulsion. This prospective randomized controlled study included a total of 70 patients with distal ureteral calculi, who presented to the outpatient clinic of El-Sahel Teaching Hospital between March 2009 and May 2011. Their age range was between 19-65 years in the Tamsulosin group and 20 - 68 years in the control group. Selection criteria included a ureteral calculus located in the distal ureter [Juxtavesical or Intramural], single, size less than 1 cm with no or minimal ipsilateral hydronephrosis and normal contralateral kidney. Patients with solitary kidney, renal insufficiency and high grade obstruction, were excluded. All patients were initially assessed by appropriate physical examination followed by plain UT and I.V.U to locate site and size of the calculus. Urinary tract ultrasound was done to exclude solitary kidney or high grade obstruction and for follow up of patients during the study. Renal functions in the form of blood urea and serum creatinine, were done. Patients with ipsilateral ureteral surgical manipulation, serious medical conditions,pregnancy and those receiving calcium channel blockers or corticosteroids, were excluded. A written informed consent was signed by all patients included in the study. The patients were randomlly categorized into 2 groups, each group consists of 35 patients: Group I [Control Group] included 35 patients who were given oral sodium diclofenac 50 mg twice/day for 10 days. Group II [Tamsulosin group] included 35 patients, who were given Tamsulosin 0.4 mg once/day for 28 days or until stone expulsion [whoever is nearer] in addition to oral sodium diclofenac 50 mg twice/day for 10 days. All patients in both groups were instructed to drink a minimum of 2 liters of water every day and for follow up including number of pain episodes, serum creatinine, KUB and urinary ultrasound. The primary endpoint of the study was the determination of the stone passage time, episodes of renal colic, need for analgesia, drug adverse effects, stone size and distal ureteral stone site whether Juxtavesical or Intramural. Sex distribution was 24 males and 11 females in group 1 [control group] compared to 22 males and 13 females in group 2 [Tamsulosin group]. Age ranges were 20 - 68 years [mean 41.2 +/- 10.55 years] and 19 - 65 years [mean 39.3 +/- 10.67years] for groups 1 and 2 respectively. Stone sizes ranged bet ween 4-10 mm in both groups [mean of 5.3 +/- 1.24 and 5.8 +/- 1.58 mm in groups 1 and 2 respectively].In both groups, no significant statistical differences,were noted as regards patients age,sex distribution or laterality [P= 0.453, P= 0.615 and P= 0.461 respectively]. The overall stone expulsion rate was 60% and 94.3% in groups 1 and 2 respectively. For stones < 6 mm, expulsion rates were 76.2% and 95.7% in groups 1 and 2 respectively. For stones 7-10 mm, the expulsion rates were 35.7% and 91.7% in groups 1 and 2 respectively.The improvements percentages in stone expulsion attained were 37.5% and 120% for stones < 6mm and 7-10 mm respectively. Episodes of renal colic were reported in 26 patients [74.3%] in the control group versus 8 patients [22.9%] in the Tamsulosin group [P< 0.001]. Tamsulosin is an effective and safe therapy for uncomplicated distal ureteral calculi as it improves stone passage rates,shortens passage time,decreases analgesia requirements and decreases the need for intervention. Moreover, these results allowed home management without hospitalization and allowed the patient to almost regularly perform everyday activities. Tamsulosin augments stone passage rates for all stone sizes especially for larger stones than smaller ones.Moreover,Tamsulosin shortens the time of stone passage especially for smaller stones than larger ones