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International Journal of Current Medical And Applied Sciences, 2015, July, 7(2),97-101.
ORIGINAL RESEARCH ARTICLE
Prospective Randomized Trial Comparing Efficacy of
Tamsulosin and Deflazacort in the Expulsion of
Lower Ureteric Calculi less than 10 m.m.in size.
Brijesh Kumar Agarwal1 & Namita Agarwal2
1Associate Professor, Department of Surgery (Urology), 2Associate Professor, Department of obstructive & Gynecology , Shri Ram Murti Smarak Institute of Medical Sciences, Ram Murti Puram,Bareilly [UP], India. ----------------------------------------------------------------------------------------------------------------------------------------------------
Abstract:
Ureteric stones are a commonly encountered problem in daily practice. Very small stones can pass easily with urine flow.
Sometimes these stones do not pass on their own. There are various possible causes of stone retention. They are ureteral
smooth muscle spasm and oedema. Long standing obstructed ureteral stones can give rise to infection and sometimes
deterioration of renal function.Surgical removal of stone by endoscope or open surgery (now a day is the only option. Now a
days to avoid surgery, medical expulsive therapy is an established treatment. Currently alpha adrenergic receptor
antagonists ( to relieve the muscle spasm) & steroids ( to reduce oedema) are being used as medical expulsive agents.
This study was carried out to study the efficacy of tamsulosin ( alpha blocker) & deflazacort (steroid) in the management of
lower ureteric stones.
A total of 90 patients with stone <10 mm in size and located in the lower ureter were taken up for the present study and
randomized in 3 equal groups. Group 1 patients (n=30) received 0.4mg of tamsulosin daily, group 2 patients(n=30) received
0.4 mg of tamsulosin and deflazacort 6 mg twice daily and group 3 patients(n=30) received placebo(control group). The
patients were given 75 mg of injection diclofenac intramuscularly on demand and followed up for 4 wks.
The average stone size for group 1,2&3 was comparable(6.2,6.8 & 6.4 mm respectively). Stone expulsion rate was 81.3% in
group 1,86.6% in group2 and 33.3% in group 3. The average stone expulsion time for group 1,2&3 was 13.20,11.95&22.6
days respectively. The results ofstudy in group 1 & Group 2 were superior to those of group 3 but did not show any
significant difference between group 1 & Group 2.
Key Words-Tamsulosin, Deflazacort, Stone Expulsion, Ureteric Stones.
Introduction:
Urinary stones is a disease that affects 12% population smooth muscle of the ureter and give rise to relieve in of the world. Symptomatic urinary stones represent the ureteric spasm and pain (2). Resultant dilataion of most common urological emergency (1). Of all the ureter can cause movement of the stone with urine flow urinary stones 70% are located in lower one third of in spite of inhibition of peristalsis. Mucosal oedema can the ureter. The transport of stone from kidney in to be reduced by deflazocart. Spontaneous passage of ureter and then in to bladder is based on two factors. stone also depends upon stone size, stone configuration They are spasm of smooth muscle of the ureter& and passage distal to it. Medical expulsive therapy is an mucosal oedema . Alfa one adrenergic receptors are established treatment for lower ureteric stones by present on the smooth muscles of the ureter and so alfa facilitating its expulsion. one adrenergic antagonist can inhibit the basal tone of Address for correspondence: Dr. Brijesh Kumar Agarwal,
Associate Professor Access this Article Online Department of Surgery [Urology], Shri Ram Murti Smarak Institute of Medical Sciences Bareilly [UP],India. Emai How to cite this article: Brijesh Kumar Agarwal et al ; Prospective Randomized Trial Subject:
Comparing Efficacy of Tamsulosin and Deflazacort in the Expulsion Medical Sciences
of Lower Ureteric Calculi less than 10 m.m.in size; International Journal of current Medical and Applied sciences; 2015, 7(2), 97-101. Quick Response Code
IJCMAAS,E-ISSN:2321-9335,P-ISSN:2321-9327. Page 97
Brijesh Kumar Agarwal & Namita Agarwal
Ureteric stones in pregnant ladies sometimes creates All patients provided informed consent. They were a problem regarding its treatment. Tamsulosin has also informed about this study. The ethical committee been approved by FDA as category B drug for use in of institute was also informed and permission was Watchful waiting approach can be used successfully in All patients were divided in to three groups. Group 1 large number of patients (3). This approach can give (30) received only tamsulosin, group 2 (30) rise to urinary infection, hydronephrosis and renal tamsulosin plus deflazacort and group 3 (30) were function deterioration if not followed properly. Several given only placebo. clinical studies have shown good results with use of In group 1 , 6 patients were pregnanat women who alfa blockers and steroids (4). We conducted a had small uretric stones in the ureter. prospective randomized trial comparing efficacy of Group one received only tamsulosin 0.4 mg orally alfa blockers and deflazocart with the group of daily. Group two received tamsulosin 0.4 mg and patients who received placebo only. deflazacort 6 mg twice daily. Group 3 received only Material and methods:
This study included consecutive 90 patients in SRMS- All patients were instructed to take three litres of fluid IMS with symptoms suggestive of ureteric calculi and were prescribed injection diclofenac 75 mg on between March 2013 to April 2015. All patients were demand in case of pain. The patients were advised to evaluated on outpatient basis and underwent a filter the urine and those who had passed stones were standard evaluation. Only patients of ureteric stone of asked to stop the medicines. All patients were less than 10 mm in size in lower 1/3 or ureter were followed for 4 wks. included in this study. The patients were followed at weekly interval with All patients presented in our outpatient department X-ray KUB and Sonography of KUB area. The stone with flank pain on either side Plain x-ray KUB and passage, stone expulsion time, number of pain Abdominal Sonograhy was done to diagnose ureteic episodes and total dose of analgesics was recorded. stone . IVP was done in all cases( except in pregnant Collected data was analysed statistically with students women). All patients also had routine blood test like test and chi-square test. HB,TLC, DLC, Blood sugar and Serum creatinine, Routine urine examination and urine culture were Results:
done in all cases. They were studied in patient's characteristics, stone The exclusion criteria included urinary tract infection, expulsion, stone expulsion time, pain episodes and diabetes mellitus, hydronephrosis, multiple stones, dose of diclofenac injection. distal ureteric surgery and history of spontaneous There is no significant difference in control and both passage of stones per urethra. study groups according to age incidence.
Table-1 : Distribution of patients according to Groups
Age (Yrs)
Group 1 (n=30)
Group 2 (n=30)
Group 3(n=30)
p value = 0.9020 (Non significant)
There is no significant difference in all three groups according to calculus size distribution.
Table-2: Patients according to Stone Size in mm
Stone Size (mm)
Group 1 (n=30)
Group 2 (n=30) Group 3 (n=30)
p value – 0.9046 (non significant)
Table-3: Patients according to Side
Group 1 (n=30)
Group 2 (n=30)
Group 3 (n=30)
p value = 0.689 (non significant) Logic Publications @ 2015, IJCMAAS, E-ISSN: 2321-9335,P-ISSN:2321-9327. Page 98
Logic Publications @ 2015, IJCMAAS, E-ISSN: 2321-9335,P-ISSN:2321-9327.

Table : 4: Patients according to Gender
Group 1 (n=30)
Group 2 (n=30)
Group 3(n=30)
p value = 0.9030 (non significant) Table : 5 showing stone expulsion rate.
Expulsion
Group 1 (n=30)
Group 2 (n=30)
Group 3 (n=30)
25 (83.3%)
26 (86.6%)
10 (33.3%)
5 (16.7%)
4 (13.4%)
20 (66.7%)
p-value between group 1 & 2 = 0.38 (insignificant), between group 1 & 3 = 0.005 (significant) and between group 2 & 3 = 0.006 (significant).
Graph 1: Stone Expulsion in Groups;
Stone Expulsion Group 1 Stone Expulsion Group 2 Stone Expulsion Group 3 Stone Expulsion Meantime to No. of Pain Analgic Injection There was no statistical significant difference in the therapy in any patient. Patients in group 2 were given age distribution, size of calculus, side of calculus and some drugs for GIT upset caused by deflazacort. sex distribution in all three groups. As shown in table and bar diagram no 1,2,3,4. Discussion;
The expulsion rate in tamsulosin alone Group 1 was Various studies have been done to evaluate the 83.3% while it was 86.6% in tamsulosin plus efficacy of various pharmacological drugs in stone deflazocart Group 2 , as compared to expulsion rate expulsion calculi specially lower one third ureteric which was only 33.3% in control Group 3. Group 1 and group 2 patients had a statistically significant stone Ueno et al (5) reported on a series of 520 patients with expulsion rate compared with group 3. The difference ureteral stones and showed that for stones 4,4-6, and in group 1 and group 2 was not statistically significant >6 mm ,the rate of spontaneous passage was 80%,59% and 21% respectively. The mean time to expulsion was 13.20 days in Group 1 Segura et al reported lower spontaneous passage rates and 11.95 days in group 2 & 28.6 days in group 3. in proximal and distal ureteric calculi more than 5 mm Groups 1& 2 had a significantly shorter expulsion time compared to group 3, but no significant difference in Watchful waiting can result in urinary tract infection, expulsion time between Group 1 & Group 2 (Graph 1) hydronephrosis, and renal function deterioration. (p-value between group 1 & 2 was 0.12, group 1 & 3 Signs of renal injury starts appearing in 3-4 weeks. was 0.002 and group 2 & 3 was 0.003). Therefore spontaneous passage of a stone can be Number of pain episodes was 0.88 and 0.78 in Group 1 awaited for 4 weeks (7). & 2 respectively was significantly less than that in Intervention is needed in all patients who have group 3(6.2 episodes). Also the mean requirement for obstruction (8). analgesic injections used was less in group 1(0.78 Various pharmacological drugs have been used to injection) and 2(0.68 injections) than in Group 3 (6.8 facilitate spontaneous passage of ureteric stones. They are steroids, glycerol trinitrate, calcium channel The side effects encountered in study groups were blockers, alfa adrenergic blockers and prostaglandin generally mild and did not require cessation of International Journal of Current Medical And Applied Sciences [IJCMAAS], Volume: 7, Issue: 2.
Brijesh Kumar Agarwal & Namita Agarwal
demonstrated the presence of alfa adrenergic time was 13.20 days in group 1 and 11.95 days in receptors in animal and human ureter (9). group 2. It was 22.6 days in control group three. Selective alfa blockers have been shown to increase Number of pain episodes was 0.88 ,0 .78 & 6.2 in the intra ureteral pressure gradient around the stone group 1 ,2 & 3 respectively, the mean requirement for impacted obstructed ureter by increasing the bolus of analgesic injections used was less in group 1 (0.78 urine above the stone and decreasing the intraureteral injection) and 2 (0.68 injections) than in group 3 (6.8 pressure below the stone (10). Alfa adrenergic blockers limit analgesic use by Our study is comparable to other studies as shown in decreasing the frequency of phasic peristaltic contraction in the obstructed ureteral tract (11). Cervenkov et al [11] Studies done by Ukhal et al (12) has shown significant Dellabella et al [13] difference in stone expulsion rate in tamsulosin verses Autenno et al [5] control group. Dellabella et al (13) reported that Peepeglia et al [9] tamsulosin resulted in an increased stone expulsion Our study 83.3% in Group I rate, decreased expulsion time, and decreased need for 86.6% in Group II hospitalization and less endoscopic procedures. Yelman et al (14) compared the efficacy of three Alpha adrenergic blocker like tamsulosin is a drug of different alfa blockers. A study done by Apporva et al choice in medical expulsion of ureteric stones. Our has compared tamsulosin and alfuzosin in stone study did not show any advantage of adding expulsion rate. They did not find any major difference deflazecort in the treatment. Considering side effects in both groups but side effect of retrograde ejaculation of steroids and not much advantage, we don't was very less in alfuzosin group. recommend deflazecort in the management of medical Porpiglia et al (15) has shown positive results in both expulsive therapy of ureteric stones. groups of nifedipine-deflazacort verses tamsulosin- We did not find more study of using tamsulosin in pregnant ladies to treat ureteric stones and to avoid Management of urinary stones in pregnant women can surgery in pregnant ladies. We need further studies in be challenging because many of the imaging this group of ladies. technologies used to localize the stones and primary therapies to remove them or ease symptoms may Conclusion:
carry risks and or side side effects for the pregnancy. A The result of this study have shown a potentially retrospective study 28 patients conducted by mayo important role of tamsulosin for conservative clinic researchers suggests that medical expulsive expulsive therapy of ureteral stones, in lower one therapy employing tamsulosin can benefit pregnant third of ureter. Obviously further studies with larger women with minimal risk to either mother or child, as number of cases are necessary to validate these reported at the AUA annual meeting in New Orleans. promising and statistically significant results. The one study suggests that tamsulosin as medical comparison with minimally invasive procedures in expulsive therapy for symptomatic stones in pregnant terms of cost and efficacy was useful, highlighting a patients is safe and may increase stone passage rates. predominant role of first line pharmacological (George bailey from Mayo Clinic In Urology Times). treatment, which can be easily be provided in an Larger cohorts will be helpful in further defining the outpatient setting and not only at large, role of tamsulosin for pregnant stone formers. The technologically advanced, specialized centers. The opinion on tamsulosin in medical expulsive therapy in drug, tamsulosin proved to be safe and effective as pregnant stone formers specially when symptoms are demonstrated by the low incidence of side effects and severe may be superior to and considering stenting, the increased stone expulsion rate and reduced URS or PCNL. As told by Dr. Bailey with Amy expulsion time. Moreover, medical expulsive therapy Krambeck and their colleagues. with tamsulsoin and deflazacort considerably Tamsulosin has been approved by FDA as categoty B decreased the analgesic use thereby reducing medicine in pregnancy i.e. study has been done in additional need for pain relief and served as an animals not in human. Tamsulosin does not cause any effective bridge between watch-and-wait management harm to animal fetus. Still tamsulosin has not been and surgical intervention. Our study also shows that approved by FDA in women. deflazacort being a steroid with GIT side effect does Our study did not show any significant difference in not add further advantage as over tamsulosin only. terms of patient age, sex distribution, stone size & Use of tamsulin in pregnant ladies with ureteric stones stone side. Spontaneous stone expulsion rate was is a topic or further studies in human beings. 81.3% in group 1 and 86.6% in group 2 as compared to group 3 where it was only 33.3%. The difference in group 1 and 2 was not statistically significant (p=0.3) References:
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Logic Publications @ 2015, IJCMAAS, E-ISSN: 2321-9335,P-ISSN:2321-9327.
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