Role of alpha blocker and steroid in better and early clearance of kidney and ureteric stones after extracorporeal lithotripsy
- Conditions
- PATIENTS WITH RENAL AND URETERIC CALCULUS SEEKING ELECTIVE PROCEDURE
- Registration Number
- CTRI/2018/04/013187
- Lead Sponsor
- SIR GANGA RAM HOSPITAL
- Brief Summary
**INDRODUCTION**
Tamsulosin, a selective α-blocker withboth α 1-A and α 1-D antagonist, has been studied by various authors in severalrecent studies but the results of studies are variable, and most of themwere carried out on patients with lower ureteric calculi. Other alpha blockersstudied and found to be effective in medical expulsive therapy are doxazosin,terazosin and selective α 1-D antagonist naftopidil.Edema is an importantfactor in arresting ureteral stone passage. Edema at the level of the stone mayexplain why even small stones cause obstruction, as demonstrated in human andanimal studies. Antiedema agents such as corticosteroids are commonly used inconjunction with calcium channel blockers or α-blockers to treat patients withureteral stones. Although very few studies have specifically evaluatedcorticosteroids, these agents have good antiedema activity, are well tolerated,and cause limited side effects when given for short periods. only a fewstudies have defined the contribution of tamsulosin and deflazacort after ESWLfor renal and upper ureteric stones. In this prospective study we will evaluatethe role of tamsulosin with or without deflazacort vs no treatment after ESWLfor ureteric and renal stones. An outcome analysis of factors like stoneclearance, expulsion time and analgesia requirement will be done.
**AIMS AND OBJECTIVES**
1. To evaluate the efficacy of tamsulosin with or withoutdeflazacort vs no treatment in terms of expulsion rate and expulsion timeof stone fragments in renal or ureteric calculus after ESWL.
2. To evaluate the effect of tamsulosinwith or without deflazacort administration on frequency of analgesic use forrelief of ureteric colic in renal or ureteric calculus after ESWL.
**Methodology:**
After clearance from ethical committeewe started our study to recruit patients of Renal or ureteric calculus, whofulfill inclusion criteria and exclusion criteria. Initially patients wereinformed regarding the study and consent was taken. After informedconsent patients were recruited in one of the three groups (A, B and C)randomly with the help of computer generated random number table. Patient inGroup A was prescribed tamsulosin (0.4 mg once daily) with deflazacort (30 mgonce daily), Group B was given tamsulosin (0.4 mg once daily) and Group Creceived No treatment (analgesics SOS and hydration therapy) after undergoingESWL. The benefits, drawbacks, and side effects of each drug were thoroughlydescribed to the patients.
Initial evaluation included a detailedclinical 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) andultrasonography or excretory urography or CT scan were performed in allcases to document stone size, location, and hydronephrosis. The ureter betweenthe pelviureteral junction and the upper border of the sacroiliac joint wasdefined as the upper ureter. The stone size was defined as the maximaldiameter.
ESWL was performed using theelectromagnetic Siemens Lithotripter (Siemens modularis variostar uro, USA) asan outpatient procedure. Five grams of eutectic mixture of lidocaine andprilocaine was applied on an approximately 30cm2 skin areacorresponding to the entry site of the shockwaves, 60 minutes before theprocedure. A maximum of 2500 shocks were delivered for each session or untilcomplete 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 fragmentationof the stone was observed. Tamsulosin with or without deflazacort wereprescribed for 7 days after every ESWL session in respective groups.
Patients were evaluated every 10 dayspost ESWL with Plain Radiography KUB / fluoroscopy and USG KUB. Patients werefollowed for maximum 60 days for stone clearance. If stone clearance wouldn’toccur within 60 days, he/she was considered as incomplete clearance.
Under analgesia protocol patients wereprescribed tablet aceclofenac 100mg with drotaverine 80 mg on SOS basis. Ifpain persisted, tablet Ketorolac 10 mg was advised. Injection diclofenac 50 mgwas given after failure of both above drugs. Patients were asked to maintainthe diary of analgesic intake. In hydration therapy patients were asked todrink at least 1 glass of water every hourly.
In the end we compared efficacy of allthree groups in terms of stone clearance, expulsion time and analgesiarequirements after ESWL.
Results :
1. Tamsulosin with andwithout deflazacort has no significant effect on stone clearance rate of renaland ureteric calculi after ESWL.
2. Tamsulosin withdeflazacort facilitates early stone clearance of stone size 10.1 – 15 mm afterESWL with statistically significant difference with no treatment group.
3. Requirement of meannumber of analgesic tablets after ESWL are decreased by tamsulosin withdeflazacort in comparison to no treatment groupsignificantly.
4. Tamsulosin with andwithout deflazacort does not decrease the required ESWL sessions significantlyin comparison to no treatment group.
5. Tamsulosinwith or without deflazacort does not decreases the incidence of steinstrasse after ESWL in renal andureteric calculi.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 135
- 1.Renal or ureteric calculi proved on plain kidney, ureter, and bladder (KUB) radiography and ultrasonography of the kidney and confirmed with intravenous urogram or CT scan 2.Size between 6 to 15 mm in major axis.
- 3.Solitary renal / ureteric calculus.
1.History of urinary tract surgery or endoscopic treatment 2.History of Concomitant treatment with alpha blockers, calcium channel blockers, or steroids 3.Morbid obesity (BMI >30) 4.History of previous failed ESWL 5.Patients with diabetes mellitus and hypertension 6.Active Urinary tract infection 7.Uncorrected Coagulopathy 8.Pregnant patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. Patients will be assessed after every 10 days upto maximum of 60 days 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. Patients will be assessed after every 10 days upto maximum of 60 days
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
SIR GANGA RAM HOSPITAL
🇮🇳Delhi, DELHI, India
SIR GANGA RAM HOSPITAL🇮🇳Delhi, DELHI, IndiaSAURABH JAINPrincipal investigator8506062026docjain.saurabh@gmail.com