Medical expulsive therapy: a cost effective evidence-based definitive treatment for ureteric stones

Abstract

Background: The lifetime risk of kidney stones is between 5% and 10% and rates of recurrence are as high as 50%.
Majority of the ureteric stones (70%) are found in the lower third of the ureter. Available setup, type, size of the
stone, and expertise of the surgeon are the major factors affecting the treatment modality. Medical expulsive therapy
has shown promising results in previous studies. Aim of the study was to assess the efficacy of tamsulosin and
deflazacort combination therapy for stone expulsion in relation with site and size of stones.
Methods: A total of 97 patients with ureteric calculi of size 10 mm or less attending the urology out-patient
department were included. Received medical expulsive therapy using tamsulosin (0.4 mg) and deflazacort (30 mg) for
7 days. Patients were evaluated for stone expulsion on 7th day by non-contrast computed tomography of kidney ureter
bladder. Site, side and size of stones were noted.
Results: Ureteric calculi was more prevalent in the age group of 21-30 years 38 (39.2%). Male preponderance was
observed (76.28%) with male female ratio being 3.2:1. Lower site 64 (65.97%) ureteric calculi were most common.
The majority had a stone size of 4-6 mm (42%). Stones were expelled on 7th day in 69 (71.13%) patients. Expulsion
rates were highest for the stone size of 2-4 mm (94.4%) followed by 4-6 mm (88.1%). The highest expulsion rates
were observed for Lower ureteric stones (84.4%).
Conclusions: Medical expulsive therapy using tamsulosin and deflazacort is an effective treatment modality for the
management of ureteric stones, especially those present in lower ureter and those ≤8 mm in size.

Full text

International Surgery Journal | September 2020 | Vol 7 | Issue 9 Page 1
International Surgery Journal
Ali Q et al. Int Surg J. 2020 Sep;7(9):xxx-xxx
http://www.ijsurgery.com
pISSN 2349-3305 | eISSN 2349-2902
Original Research Article
Medical expulsive therapy: a cost effective evidence-based definitive
treatment for ureteric stones
Qutubuddin Ali, Shehtaj Khan, Gambhir Patel*, Kritik Jaiswal, Krishnanand
INTRODUCTION
The lifetime risk of kidney stones is between 5% and
10% and rates of recurrence are as high as 50%.1,2 It is
estimated that renal colic affects about 10-20% of men,
and 3-5% of women. In India, 12% of the population is
expected to have urinary stones, out of which 50% may
end up with loss of kidney or renal damage.3 A large
number of people, nearly 4-15% of the human
populations, are suffering from urinary stones all over the
globe.4
Multiple modalities are being used for removal of Kidney
stones such as medical therapy, ureteroscopy, shock wave
lithotripsy, percutaneous nephrostolithotomy, and
open/laparoscopic stone removal. Combinations of these
modalities are also being used.5 The choice of treatment
modality is determined by several factors including setup
available, type and size of the stone, and expertise of the
surgeon.
The possibility of kidney stone passing down the ureter
depends on stone dimensions and ureteral conditions.
ABSTRACT
Background: The lifetime risk of kidney stones is between 5% and 10% and rates of recurrence are as high as 50%.
Majority of the ureteric stones (70%) are found in the lower third of the ureter. Available setup, type, size of the
stone, and expertise of the surgeon are the major factors affecting the treatment modality. Medical expulsive therapy
has shown promising results in previous studies. Aim of the study was to assess the efficacy of tamsulosin and
deflazacort combination therapy for stone expulsion in relation with site and size of stones.
Methods: A total of 97 patients with ureteric calculi of size 10 mm or less attending the urology out-patient
department were included. Received medical expulsive therapy using tamsulosin (0.4 mg) and deflazacort (30 mg) for
7 days. Patients were evaluated for stone expulsion on 7th day by non-contrast computed tomography of kidney ureter
bladder. Site, side and size of stones were noted.
Results: Ureteric calculi was more prevalent in the age group of 21-30 years 38 (39.2%). Male preponderance was
observed (76.28%) with male female ratio being 3.2:1. Lower site 64 (65.97%) ureteric calculi were most common.
The majority had a stone size of 4-6 mm (42%). Stones were expelled on 7th day in 69 (71.13%) patients. Expulsion
rates were highest for the stone size of 2-4 mm (94.4%) followed by 4-6 mm (88.1%). The highest expulsion rates
were observed for Lower ureteric stones (84.4%).
Conclusions: Medical expulsive therapy using tamsulosin and deflazacort is an effective treatment modality for the
management of ureteric stones, especially those present in lower ureter and those ≤8 mm in size.
Keywords: Lower ureter, Medical expulsive therapy, Stone size, Ureteric calculi, Urolithiasis
Department of General Surgery, L.N. Medical College and Research Center, Bhopal, Madhya Pradesh, India
Received: 15 July 2020
Revised: 29 July 2020
Accepted: 30 July 2020
*Correspondence:
Dr. Gambhir Patel,
E-mail: drgambhirpatel@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: http://dx.doi.org/10.18203/2349-2902.isj20203508

Ali Q et al. Int Surg J. 2020 Sep;7(9):xxx-xxx
International Surgery Journal | September 2020 | Vol 7 | Issue 9 Page 2
Though several studies have shown spontaneous passage
of the stone which ranges from 71-98% for the stone size
<5 mm, for stone having a size between 5-10 mm the
rates of spontaneous passage are significantly lower
which range from 25-53% only.6
Medical expulsive therapy (MET) is an effective
conservative treatment option for managing ureteral
stones. Alpha-blockers, calcium channel blockers,
corticosteroids, and phosphodiesterase-5 (PDE5)
inhibitors are some of the agents used under MET. 6,7
Tamsulosin is a selective α1 receptor antagonist whereas
deflazacort is a glucocorticoid. Though studies have
found that tamsulosin along with deflazacort is a very
effective therapy for the expulsion of stones, the data
evaluating the use of tamsulosin and deflazacort for stone
expulsion is limited in the Indian population.8-11 Hence,
this study was done to assess the efficacy of MET with
tamsulosin and deflazacort in the stone expulsion rate in
relation with site and size of stones.
METHODS
This was a prospective study done at L.N. Medical
College and Research Center with attached J.K. Hospital,
Bhopal from January 2019 to December 2019. All
patients with ureteric stone ≤10 mm in size were included
in the study. And stone size more than 10 mm, bilateral
ureteric stones, impacted stone, UTI or severe
hydronephrosis, anatomically abnormal urinary tract,
pregnant females, anatomically solitary or solitary
functioning kidney, patients in whom steroids were
contraindicated. patients not given consent for study were
excluded from the study.
Procedure
After informed consent, patients were given tamsulosin
0.4 mg and deflazacort 30 mg for 7 days. They were
followed upon 7th day and evaluated for stone expulsion
by non-contrast computerized tomography (NCCT)–
kidneys ureters bladder. Patient particulars, side, site and
size of stones and NCCT findings were noted. Ethical
approval was taken from institutional ethics committee.
Statistical analysis
The data analysis was performed using IBM SPSS ver. 20
software. Age of study cohort was expressed as mean and
standard deviation whereas categorical data were
expressed as numbers and percentages. Categorical data
was compared using the Chi-Square test. P-value of
<0.05 was considered significant.
RESULTS
A total of 113 patients were enrolled in this study but 16
patients were lost in follow up. Hence, 97 patients were
finally included in the study.
The mean age of the study cohort was 32.42±6.12 years.
Ureteric calculi were more prevalent in the age group of
21-30 years (n=38) followed by 31-40 years (n=28) and
41-50 years (n=16). No patients in the age between 1-10
years had ureteric calculi in the present study. Ureteric
calculi were more prevalent among male 74 (76.28%)
populations compared to females 23 (23.71%), with male
to female ratio was 3.2:1. Almost equal distribution was
recorded for ureteric calculi on both the sides (right side
48 patients, left side 49 patients).
Analysis on the basis of stone size revealed that upto
8 mm size, the expulsion rates were significantly higher,
whereas in stones more than 8 mm size, significantly
lower rate of expulsion was seen (Table 1).
Table 1: The expulsion rate at different size.
Size of stone
(mm)
Expulsion
Yes N (%)
Expulsion
No N (%)
P value
2-4
17 (94.4)
1 (5.5)
<0.001
>4-6
37 (88.1)
5 (11.9)
<0.05
>6-8
12 (63.2)
7 (36.8)
<0.05
>8-10
3 (16.7)
15 (83.3)
<0.001
Analyzing the site of stones, it was revealed that lower
ureteric calculi were found in 64 (65.97%) patients as
compared to the upper 21 (21.64%) and middle ureter 12
(12.34%). Expulsion was significantly more in lower
ureteric stone and quite less in upper ureter (Table 2).
Overall out of 97 patients, stone expulsion was observed
in 69 (71.13%) patients.
Table 2: The expulsion rate at different sites.
Site of stone
Expulsion
Yes N (%)
Expulsion
No N (%)
P value
Upper ureteric
stone
8 (38.1)
13 (61.9)
<0.05
Middle ureteric
stone
7 (58.3)
5 (41.7)
0.286
Lower ureteric
stone
54 (84.4)
10 (15.6)
<0.001
DISCUSSION
Removal with the help of ureteroscopy is the best option
for stones in ureter, but it requires anaesthesia and
stenting which increases the cost of treatment as well as
loss of productive work hours due to hospitalization.12
Cases of symptomatic distal ureteric calculus are suitable
for expulsion using a proper pharmacological agent.
Previous studies are in agreement with using tamsulosin
as an effective measure for the expulsion of stones.8-11
Also, it is well known that ureteric stone results in edema
of the ureter. A pharmacological agent that acts by
reducing the edema of the ureter and maintaining the
tonicity of the ureter can be used along with the

Ali Q et al. Int Surg J. 2020 Sep;7(9):xxx-xxx
International Surgery Journal | September 2020 | Vol 7 | Issue 9 Page 3
tamsulosin. The steroid has anti-inflammatory action.13
That means a combination of tamsulosin with steroids
can be an effective treatment modality for the expulsion
of stones. In the present study, we evaluated the role of
this combination in the expulsion of stones in 97 patients
with calculi of various sizes at different sites in ureter.
Tamsulosin has antagonistic action on alpha-1A and
alpha-1D receptors which are mainly present in the distal
ureteral tract. Antiedemic effects of deflazacort are also
established. Both drugs are well tolerated and have very
few side effects.14 Kidney stone are quite common and
usually affect people who are between 30 and 60 years of
age.3 They affect more men than women.3 The mean age
of this study was 32.42±6.12 years (range: 20-60 years)
with male to female ratio was 3.2:1, which was similar to
study done by Ramesh et al with mean age 34.94 years
(range: 19-62 years).15
In a study from Gurugram, Haryana by Sinha et al
comparing the effect of tamsulosin alone with tamsulosin
and deflazacort combination has shown that results were
excellent with the combination therapy recording the
expulsion rate of 76% as compared to tamsulosin alone
(52%) which are in line with our findings.8
In another study by Porpiglia et al comparing the
combination (n=33) with tamsulosin (n=30) and
deflazacort (n=24) in patients having a stone size of
≥5 mm present in distal location reported that the
expulsion rate was 84.8%, 60% and 37.5% respectively
which highlight the usefulness of combination therapy.16
In the present study expulsion rate was 71.13%.
Expulsion rate according to the site of the stone was more
for lower ureteric stone (84.4%) compared to middle
ureteric stone (58.3%) and upper ureteric stone (38.1%).
In a study done by Ahmed et al on stones ≤10 mm,
66.66% from upper ureter, 100% from middle ureter and
92.30% from lower ureteric calculus were expelled on
tamsulosin therapy.17 Another study by Coll et al showed
that spontaneous expulsion of stones were 48% in
proximal, 60% in middle and 75% in distal ureter for
various sizes of stones.18
Dellabella et al also compared the expulsion rates of
phloroglucinol, tamsulosin, or nifedipine in 210
symptomatic patients with distal ureteral calculi ≥4 mm
where all the patients received deflazacort. It was found
that the expulsion rate was significantly higher in
tamsulosin and deflazacort group (97.1%) than in
phloroglucinol (64.3%, p<0.0001) or nifedipine (77.1%,
p<0.0001). In addition to high expulsion rates with
tamsulosin and deflazacort, there was a significantly
faster stone passage than the other 2 groups and there was
a significantly decreased number of hospitalizations as
well as a better decrease in endoscopic procedures
performed to remove the stone.9 In comparison, our study
showed expulsion of stone size upto 4 mm in 94.5% and
4-8 mm in 80.32%. There was significant non expulsion
of stone >8 mm size.
Cross-sectional nature and small sample size were the
main limitations of the present study, there is a need for a
large clinical trial provide strength to present study
findings.
CONCLUSION
It was found that medical expulsive therapy using
tamsulosin and deflazacort has good expulsion rates
mainly for the lower ureteric stone and stone size upto
8 mm. It is a good therapeutic option due to cost-
effectiveness and resuming of early routine work by the
patients.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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Cite this article as: Ali Q, Khan S, Patel G, Jaiswal
K, Krishnanand. Medical expulsive therapy: a cost
effective evidence-based definitive treatment for
ureteric stones. Int Surg J 2020;7:xxx-xx.