JCU - January 2022 - 14

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Journal of Clinical Urology 15(1)
receptor, leading to fewer contractures. Hence, it may be
conducive to less pressure at the bladder outlet.6 Also, cystone
is a herbal agent combined from didymocarpuspedicellata
65 mg, saxifragaligulata 49 mg, rubiacordifolia 16 mg,
cyperusscariosus 16 mg, achyranthesaspera 16 mg, onosmabracteatum
16 mg, vernoniacinerea 16 mg, shilajeet
(purified) 13 mg and hajrulyahoodbhasma 16 mg.8 The efficacy
of cystone is related to the removal of crystalurea and
small stone passage besides the diuretic and anti-spasmodic
effects.7, 8 Determination of the best therapeutic method
would require further studies.9 Accordingly, in this study the
efficacy of cystone versus tamsulosin in thhe treatment of
stent-related lower urinary tract symptoms was determined.
Materials and methods
This double-blind, prospective, placebo controlled, clinical
randomised trial was carried out on 132 patients requiring
double-J stent after a transureteral lithotripsy (TUL) procedure
during 2018-2019 in a tertiary urological centre.
Inclusion criteria were the patients who underwent a unilateral
TUL. All patients had an impacted 6-10 mm, middle or
distal ureteral stone. However, patients with a bilateral ureteral
stone, history of renal failure or urosepsis, anatomical
or functional ureteral abnormality were excluded. The international
prostate symptom score (IPSS) and visual analogue
score (VAS) were fulfilled before stent insertion, after 2
weeks and after 4 weeks. IPSS included both voiding and
storage symptom points with a total score of 0 to 35 points.
The pain was also assessed by VAS ranging from 0 to 10
points by a single examiner. More VAS and IPSS indicate
more severity in lower urinary tract symptoms.
After consulting with the methodologist, we allocated 160
applicants into four groups of 40 patients, using the random
number table method (as simple randomisation) found in statistics
books. However, 32 patients did not complete the study
and the data of 128 patients were enrolled. These patients
received tamsulosin (n=32), cystone (n=35), tamsulosin plus
cystone (n=37) and placebo (n=24). Regarding concealment,
the randomisation list was concealed from patients and all
clinical investigators. An off-site person labelled the drug
packages with coded numbers. The randomised controlled
trial (RCT) study was approved by both the local ethical committee
(registration ID: 1396.8923496021) and clinical trial
registery (study ID: TCTR20200705001). The Declaration of
Helsinki was respected, as well as an informed consent form
was received.
The primary endpoint was to compare the study groups
regarding the IPSS and VAS, 2 and 4 weeks after drug
administration.
Statistical analysis
Mean ± standard deviation was used to describe quantitative
variables; and categorical data were described using
counts and percentages. An analysis of variance (ANOVA)
repeated measure was used to compare quantitative variables
and to study the trend. Statistical analysis was done
using the Statistical Package for Social Sciences, version
21.0 (IBM SPSS Statistics Inc., Chicago, IL, USA).
Results
Finally, 128 patients including 84 men (65.5%) and 44
women (34.4%) completed the study. The patients had been
randomely divided into four groups of tamsulosin (n=32),
cystone (n=35), tamsulosin plus cystone (n=37) and placebo
(n=24). Figure 1 shows the flowchart of study participants.
The mean age was 45.2 ± 13.9 (ranging from 20 to 82) years.
No significant side effects, such as gross haematuria and
acute urinary infection and so on, were reported in this study.
The mean pain score of patients was evaluated based on
the VAS at baseline, 2 and 4 weeks. The results showed
that there was no significant difference in baseline pain
score among the three groups before the stent was inserted
(P=0.064); however, at 2 and 4 weeks, the mean pain score
was significantly different among the three case groups
and the placebo group (P<0.001). We depict the VAS
results in Table 1 and Figure 2, as well as the IPSS results
in Table 2 and Figure 3.
Table 1 shows the mean pain score of patients based on
the VAS at baseline, 2 and 4 weeks. The results of post hoc
LSD tests showed that the mean VAS in the placebo group at
2 and 4 weeks was significantly higher than the other groups
(P<0.05). The mean pain score of the patients was evaluated
at baseline, 2 and 4 weeks, in such a way that pain was significantly
different during the three time points (P<0.001).
Figure 2 shows the trend, error bar, and mean pain at baseline,
2 and 4 weeks. The mean VAS score of patients at baseline,
2 and 4 weeks showed no significant difference in baseline
among the three groups (P=0.989), but at 2 and 4 weeks the
mean VAS score was significantly different among the three
groups and the placebo group (P<0.001). Post hoc tests showed
that the mean VAS score in the placebo group at 2 and 4 weeks
was significantly higher than the other three groups (P<0.05).
In addition, the mean VAS in the tamsulosin group was significantly
higher than the cystone group at 4 weeks (P=0.017).
Table 2 shows that the mean IPSS trend of baseline
patients at baseline, 2 weeks and 4 weeks was evaluated
and the results showed that it was significantly changed
during the three time points (P<0.001).
Figure 3 shows the trend, error bar and mean IPSS at
baseline, 2 and 4 weeks. Post hoc tests showed that the
mean IPSS in the placebo group was significantly higher
than the other groups (P<0.05). Also, the mean IPSS in
the tamsulosin group was significantly higher than the
tamsulosin plus cystone group at 4 weeks (P=0.014).
Discussion
In this study, the efficacy of tamsulosin and cystone in an
improvement of the urinary symptoms after double-J stent

JCU - January 2022

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