INDRODUCTION

Tamsulosin, a selective α-blocker with both α 1-A and α 1-D antagonist, has been studied by various authors in several recent studies but the results of studies are variable, and most of them were carried out on patients with lower ureteric calculi. Other alpha blockers studied and found to be effective in medical expulsive therapy are doxazosin, terazosin and selective α 1-D antagonist naftopidil.Edema is an important factor in arresting ureteral stone passage. Edema at the level of the stone may explain why even small stones cause obstruction, as demonstrated in human and animal studies. Antiedema agents such as corticosteroids are commonly used in conjunction with calcium channel blockers or α-blockers to treat patients with ureteral stones. Although very few studies have specifically evaluated corticosteroids, these agents have good antiedema activity, are well tolerated, and cause limited side effects when given for short periods. only a few studies have defined the contribution of tamsulosin and deflazacort after ESWL for renal and upper ureteric stones. In this prospective study we will evaluate the role of tamsulosin with or without deflazacort vs no treatment after ESWL for ureteric and renal stones. An outcome analysis of factors like stone clearance, expulsion time and analgesia requirement will be done.

AIMS AND OBJECTIVES

1.      To evaluate the efficacy of tamsulosin with or without deflazacort vs no treatment in terms of expulsion rate and expulsion time of stone fragments in renal or ureteric calculus after ESWL.

2.         To evaluate the effect of tamsulosin with or without deflazacort administration on frequency of analgesic use for relief of ureteric colic in renal or ureteric calculus after ESWL.

Methodology: 

After clearance from ethical committee we started our study to recruit patients of Renal or ureteric calculus, who fulfill inclusion criteria and exclusion criteria. Initially patients were informed regarding the study and consent was taken.  After informed consent patients were recruited in one of the three groups (A, B and C) randomly with the help of computer generated random number table. Patient in Group A was prescribed tamsulosin (0.4 mg once daily) with deflazacort (30 mg once daily), Group B was given tamsulosin (0.4 mg once daily) and Group C received No treatment (analgesics SOS and hydration therapy) after undergoing ESWL. The benefits, drawbacks, and side effects of each drug were thoroughly described to the patients.

Initial evaluation included a detailed clinical history, blood and urine investigations including a complete hemogram, kidney function test, urine routine microscopy and urine culture sensitivity. Preoperative plain X-ray of the kidneys, ureter and bladder (KUB) and ultrasonography or excretory urography or CT scan were  performed in all cases to document stone size, location, and hydronephrosis. The ureter between the pelviureteral junction and the upper border of the sacroiliac joint was defined as the upper ureter. The stone size was defined as the maximal diameter.

ESWL was performed using the electromagnetic Siemens Lithotripter (Siemens modularis variostar uro, USA) as an outpatient procedure. Five grams of eutectic mixture of lidocaine and prilocaine was applied on an approximately 30cm² skin area corresponding to the entry site of the shockwaves, 60 minutes before the procedure. A maximum of 2500 shocks were delivered for each session or until complete fragmentation of the stone had occurred as judged by fluoroscopy. Following each session, the patient was observed for 2 hours in recovery. Repeat session of ESWL was performed after 10 days if inadequate fragmentation of the stone was observed. Tamsulosin with or without deflazacort were prescribed for 7 days after every ESWL session in respective groups.

Patients were evaluated every 10 days post ESWL with Plain Radiography KUB / fluoroscopy and USG KUB. Patients were followed for maximum 60 days for stone clearance. If stone clearance wouldn’t occur within 60 days, he/she was considered as incomplete clearance.

Under analgesia protocol patients were prescribed tablet aceclofenac 100mg with drotaverine 80 mg on SOS basis. If pain persisted, tablet Ketorolac 10 mg was advised. Injection diclofenac 50 mg was given after failure of both above drugs. Patients were asked to maintain the diary of analgesic intake. In hydration therapy patients were asked to drink at least 1 glass of water every hourly.

In the end we compared efficacy of all three groups in terms of stone clearance, expulsion time and analgesia requirements after ESWL.

Results :

1.   Tamsulosin with and without deflazacort has no significant effect on stone clearance rate of renal and ureteric calculi after ESWL.

2.   Tamsulosin with deflazacort facilitates early stone clearance of stone size 10.1 – 15 mm after ESWL with statistically significant difference with no treatment group.

3.      Requirement of mean number of analgesic tablets after ESWL are decreased by tamsulosin with deflazacort in comparison to no treatment groupsignificantly.

4.      Tamsulosin with and without deflazacort does not decrease the required ESWL sessions significantly in comparison to no treatment group.

  5. Tamsulosin with or without deflazacort does not decreases the incidence of       steinstrasse after ESWL in renal and ureteric calculi.