Invest Clin 67(1): 30 - 44, 2026 https://doi.org/10.54817/IC.v67n1a03
Corresponding author: Daichang Li. Department of Urology, Wuyi Branch, Run Run Shaw Hospital, Shuxi Sub-
district, Wuyi County, Jinhua Zhejiang Province, China. Email: Li1908chang@hotmail.com
Assessment of the efficacy of tamsulosin
and potassium citrate in promoting
spontaneous ureteral stone expulsion.
Lihua Liu1, Kai Zhang1 and Daichang Li2
1Huzhou Wuxing District People's Hospital, Huzhou Wuxing District Matemal and Child
Health Hospital, Huzhou, Zheijan Province, China.
2Department of Urology, Wuyi Branch, Run Run Shaw Hospital, Shuxi Sub-district,
Wuyi County, Jinhua Zhejiang Province, China.
Keywords: Tamsulosin; Potassium Citrate; Ureteral Calculi; Lithotripsy; Spontaneous
Expulsion.
Abstract. This study aimed to evaluate the effectiveness of tamsulosin com-
bined with potassium citrate in promoting the spontaneous passage of ureteral
stones ≤10 mm. A retrospective analysis was performed on 100 patients admit-
ted between January 2020 and December 2023. Patients were divided into four
groups: tamsulosin (0.4 mg/day), potassium citrate (3 g/day), combined treat-
ment (tamsulosin + potassium citrate), and a control group (analgesics only
+ regular water intake). Primary outcomes assessed over four weeks included
stone passage rate, passage time, stone location and composition, and safety.
Secondary outcomes covered pain control, imaging and laboratory indicators,
and quality of life. Baseline characteristics were comparable across groups. The
combined treatment group showed the highest stone expulsion rate, which
was significantly higher than that of the tamsulosin, potassium citrate, and
control groups (p<0.05). The median stone expulsion time was also shortest
in the combined group (p<0.05). Expulsion rates for lower ureteral stones,
uric acid stones, and calcium stones were significantly higher in the combined
group (p<0.05), while the rate for upper stones was not statistically significant
(p>0.05). No serious adverse events occurred, and safety profiles were similar
across all groups. Secondary outcomes, including pain control and quality of
life, showed significant improvements in the combined group compared with
the other groups (p<0.05). The combination of tamsulosin and potassium ci-
trate significantly increases the rate and shortens the time of spontaneous ure-
teral stone expulsion, with good safety and improved quality of life, supporting
its role in medical expulsive therapy.
Tamsulosin and potassium citrate in ureteral stone expulsion 31
Vol. 67(1): 30 - 44, 2026
Evaluación de la eficacia de tamsulosina y citrato de potasio
en la promoción de la expulsión espontánea de cálculos
ureterales.
Invest Clin 2026; 67 (1): 30 – 44
Palabras clave: Tamsulosina; Citrato de Potasio; Cálculos Ureterales; Litotricia p;
Expulsión Espontánea.
Resumen. Este estudio tuvo como objetivo evaluar la eficacia de la tamsu-
losina combinada con citrato de potasio para promover la expulsión espontánea
de cálculos ureterales de menos de 10 mm. Se realizó un análisis retrospectivo
de 100 pacientes ingresados entre enero de 2020 y diciembre de 2023. Los
pacientes se dividieron en cuatro grupos: tamsulosina (0,4 mg/día), citrato de
potasio (3 g/día), tratamiento combinado (tamsulosina + citrato de potasio)
y un grupo de control (solo analgesia + ingesta hídrica regular). Los resul-
tados primarios evaluados durante 4 semanas fueron la tasa y el tiempo de
expulsión del cálculo, la ubicación y composición del cálculo, y la seguridad.
Los resultados secundarios incluyeron el control del dolor, los indicadores de
imagen y de laboratorio y la calidad de vida. Las características basales fueron
comparables entre los grupos. El grupo de tratamiento combinado presentó la
tasa de expulsión de cálculos más alta, significativamente mayor que la de los
grupos de tamsulosina, citrato de potasio y control (p<0,05). La mediana del
tiempo de expulsión del cálculo también fue la más corta en el grupo combina-
do (p<0,05). Las tasas de expulsión de cálculos en el uréter inferior, de ácido
úrico y de calcio fueron significativamente más altas en el grupo combinado
(p<0,05), mientras que la tasa de expulsión de cálculos superiores no fue esta-
dísticamente significativa (p>0,05). No se registraron eventos adversos graves
y los perfiles de seguridad fueron similares en todos los grupos. Los resultados
secundarios, incluidos el control del dolor y la calidad de vida, mostraron una
mejoría significativa en el grupo combinado en comparación con los demás
grupos (p<0,05). La combinación de tamsulosina y citrato de potasio aumen-
ta significativamente la tasa y acorta el tiempo de la expulsión espontánea de
cálculos ureterales, con buena seguridad y mejora de la calidad de vida, lo que
respalda su valor en la terapia médica expulsiva.
Received: 18-08-2025 Accepted: 21-12-2025
INTRODUCTION
Ureteral stones are a common condi-
tion of the urinary system, and their occur-
rence is rising worldwide. Approximately 80%
of patients with ureteral stones less than 10
mm in diameter can pass them spontane-
ously with conservative treatment 1, but this
process is often accompanied by severe pain
and potential complications 2. Despite re-
cent advances in diagnostic and therapeutic
methods, pharmacological excretory ther-
apy (MET) is increasingly recognized as an
important non-surgical treatment option 3, 4.
Tamsulosin, a highly selective α1A/D
adrenergic receptor blocker, has been shown
32 Liu et al.
Investigación Clínica 67(1): 2026
in several studies to reduce intraureteral
pressure by relaxing the smooth muscle of
the lower ureter, thereby promoting stone
expulsion 5. Its mechanism of action mainly
includes 6, 7: (1) selectively blocking the α1D
receptor on ureteral smooth muscle, reduc-
ing the frequency and amplitude of ureteral
peristalsis; (2) reducing the edema of the
ureteral wall; and (3) improving the urinary
drainage proximal to the stone. Clinical stud-
ies have shown that tamsulosin significantly
increases the rate and shortens the duration
of stone expulsion from the distal ureter and
reduces episodes of renal colic 8. Potassium
citrate, as an alkaline drug, has multiple
roles in the treatment of urinary stones 9-11:
(1) increase the solubility of uric acid and
cystine stones by alkalinizing the urine; (2)
inhibit the formation of calcium salt crys-
tals; and (3) replenish citrate to correct
hypo-citraturia. In recent years, potassium
citrate has been found to promote stone ex-
pulsion by altering stone surface charge and
reducing their adhesion to the urinary tract
epithelium. Some studies have shown that
combination therapy is superior to mono-
therapy, and the rationale for combination
therapy is that the two drugs may synergize
to promote stone clearance through differ-
ent mechanisms: tamsulosin acts primarily
on ureteral dynamics, and potassium citrate
may alter the physicochemical properties of
the stone 12.
In clinical practice, the choice of treat-
ment for ureteral stones requires consider-
ation of several factors, including stone size,
location, composition, symptom severity,
and individual patient characteristics. In
general, stones <5 mm in diameter have a
high rate of spontaneous expulsion, where-
as those 5-10 mm in diameter have a sig-
nificantly lower rate of spontaneous expul-
sion13. Stone location is also an important
factor influencing stone expulsion, with dis-
tal ureteral stones typically having a higher
expulsion rate than proximal stones 14. In
addition, stone composition, ureteral ana-
tomical variations, and previous history of
stone evacuation can affect treatment out-
comes. Therefore, the search for a more ef-
fective pharmacological lithotripsy regimen
is of great clinical importance. The aim of
this study was to systematically evaluate the
promotion effect of tamsulosin and potassi-
um citrate alone and in combination on the
spontaneous expulsion of ureteral stones,
to compare the differences in stone expul-
sion rate, time to expulsion, and degree of
pain relief, and to explore the effect of stone
composition on drug efficacy, with a view to
providing an evidence-based basis for the
clinical development of an individualized
treatment regimen. The results of the study
will help optimize the conservative treat-
ment strategy for ureteral stones, reduce pa-
tient pain, and medical costs.
MATERIALS AND METHODS
Study design and participants
This is a clinical retrospective study
aimed at evaluating the clinical effectiveness
of tamsulosin therapy and potassium citrate
in promoting the spontaneous passage of
ureteral stones. The clinical data of patients
with ureteral stones admitted to our hospi-
tal from January 2020 to December 2023
were collected, and 100 patients were ulti-
mately included. These patients were divided
into four groups based on their treatment
protocols: tamsulosin group (0.4 mg/d),
potassium citrate group (3 g/d), combined
treatment group (tamsulosin + potassium
citrate), and a control group (symptomatic
treatment only). The flow chart of this study
is shown in Fig. 1.
Inclusion, exclusion, and withdrawal
criteria
Inclusion criteria: age 18-70 years; uni-
lateral primary ureteral stone diagnosed
by abdominal Computed Tomography (CT)
scanning 15; maximum stone diameter 5-10
mm (longest diameter measured by CT) 16;
receiving at least 2 weeks of standardized
medication; having complete 4-week follow-
Tamsulosin and potassium citrate in ureteral stone expulsion 33
Vol. 67(1): 30 - 44, 2026
up data; and a normal contralateral urinary
tract.
Exclusion criteria: renal insufficiency;
history of previous ureteral surgery on the af-
fected side; pregnant women; recurrent renal
colic during the follow-up period, ineffective
conservative treatment, requiring surgical
treatment; comorbidity with severe urinary
tract infections requiring surgical treatment;
and recent use of oral calcium channel block-
ers or alpha-1 receptor blockers.
Withdrawal criteria: exacerbation of
the condition during follow-up (worsening
of infection or recurrent renal colic); due
to non-collection of stones (e.g., complete
dissolution of stones or stone exclusion not
detected); and stone composition analysis
(using chemical analysis) in all patients, if
the composition of the stones is non-uric
acid stones.
Ethics statement
The study strictly followed the require-
ments of the Declaration of Helsinki and
the ethical guidelines of the Wuxing District
People’s Hospital of Huzhou City and was ap-
proved by this Hospital’s Ethics Committee.
Research methodology
Patients’ baseline data (age, gender,
stone characteristics, etc.) were collect-
ed, and the calculus clearance achieved by
4-week follow-up was recorded. The primary
observation index was the rate of stone ex-
pulsion (confirmed by ultrasound or CT),
and the secondary indexes included the time
of expulsion, the number of pain episodes
and the adverse drug reactions. Blinded,
unifactorial and multifactorial logistic re-
gression were used to analyze the relevant
factors affecting stone expulsion.
How the medication was administered: 2
packets of potassium citrate three times a day,
dissolved in warm boiled water. Tamsulosin 0.2
mg/d, 1 time/d, taken orally after meals. Dur-
ing follow-up, each group had episodes of renal
colic and was given diclofenac for pain relief.
The placebo group was given diclofenac only
at the onset of renal colic and no other medi-
cation. Patients in each group were asked to
drink >2 L of water per day 17. The follow-up
period was four weeks and was terminated if
the stone was expelled within that period. Sur-
gery was recommended for those who had not
expelled the stone within four weeks.
Fig. 1. Flow diagram of patients included in the analysis.
34 Liu et al.
Investigación Clínica 67(1): 2026
Observation indicators
General information
Age, BMI (Body Mass Index), stone size,
stone location, CT value [Hounsfield Unit
(HU)], blood creatinine, uric acid, urine hy-
drogen ion concentration (pH), hypertension,
diabetes mellitus, and the presence of hyper-
uricemia were recorded for the patients. A
total of 110 patients met the inclusion and
exclusion criteria for this trial, but 10 were
excluded. The remaining 100 patients were
divided into four groups based on the inter-
vention method: 25 patients in the tamsulo-
sin group, 25 in the potassium citrate group,
25 in the combined treatment group (tam-
sulosin + potassium citrate), and 25 in the
control group (symptomatic treatment only).
Observation indicators
1. Recorded imaging assessment (4-week
rate of complete stone expulsion)
All patients underwent low-dose unen-
hanced CT scans before (baseline) and after
4 weeks (±3 days) of treatment to indepen-
dently assess the rate of complete stone ex-
pulsion using a blinded method.
2. Median time to stone expulsion
Confirmation of median stone expul-
sion time by imaging.
3. Stone location and composition
The location and composition of stones
were examined using imaging and infrared
spectroscopy, respectively, in each patient
group.
4. Adverse reactions
Hypotension, nausea, vomiting, abdom-
inal pain, diarrhea, and allergic reactions
were recorded in each group.
5. Pain control effects
The visual analogue scale (VAS) was
used to assess pain, with 0 indicating no
pain and 10 representing the worst pain
imaginable; higher scores indicate greater
pain. The maximum reduction in VAS score
was identified by noting the time when the
patient first reported a significant decrease
in pain and counting the number of pain epi-
sodes recorded daily, starting from the time
of drug administration.
6. Imaging and laboratory indicators
The location of the stone was deter-
mined by CT before treatment, and CT was
reviewed after treatment to measure the
new position of the stone, calculate the
three-dimensional spatial travel distance us-
ing the software Mimics Imaging, compare
the average speed of stone movement (mm/
day) among different treatment groups, and
record the separate distances of stone move-
ment. Multislice spiral CT scanning was used
to calculate changes in fluid volume with
the software Mimics. The 24-hour urinary
citrate level was recorded through sample
collection.
7. Quality of life indicators
The patients were evaluated using the
EuroQol 5-Dimensions 5-Levels (EQ-5D-5L)
scale, which assesses mobility, self-care, dai-
ly activities, pain or discomfort, and anxiety
or depression. Higher scores indicated poor-
er health status. The time taken to return
to daily activities was also recorded, with
shorter times reflecting higher patient sat-
isfaction.
Statistical analyses
Per protocol, statistical analysis was
conducted using SPSS 26.0. Efficacy end-
points (measured as mean ± SD) were ana-
lyzed with ANCOVA, adjusting for baseline
values. Safety data (categorical) were com-
pared using χ² tests with Yates’ correction.
The significance level was kept at 0.05 with-
out applying multiplicity adjustment for this
exploratory analysis.
RESULTS
Comparison of general information
A total of 110 patients met the inclu-
sion and exclusion criteria for this trial; 10
declined to participate and were excluded.
The remaining 100 patients were allocated
Tamsulosin and potassium citrate in ureteral stone expulsion 35
Vol. 67(1): 30 - 44, 2026
25 per group to the tamsulosin, potassium
citrate, combined treatment, and control
groups, according to the intervention mo-
dality. The demographic characteristics and
baseline data of the subjects in the four
groups were analyzed and were not statisti-
cally significant (p>0.05), indicating that
the four groups were comparable at the pre-
treatment level. As shown in Table 1.
Comparison of the efficacy of tamsulosin,
potassium citrate and combination
therapy in promoting spontaneous
ureteral stone expulsion
The analysis of the effectiveness of the
index in promoting spontaneous ureteral
stone discharge is shown in Table 2. The
stone discharge rate in the combined treat-
ment group was optimal, with an 84.6%
rate at 84.6 weeks, which was significantly
higher than the rates in the single-drug
groups (68.2% in the tamsulosin group and
62.1% in the potassium citrate group) and
the control group (46.3%). This difference
was statistically significant (p<0.001). This
suggests that the combined treatment may
significantly improve stone discharge effi-
ciency through a synergistic effect (tamsu-
losin relaxes the ureter + potassium citrate
dissolves uric acid stones). The median time
to stone expulsion was shortest in the com-
bination therapy group (6.5 days), shorter
than in the monotherapy groups (9.3 days
in the tamsulosin group and 11.7 days in the
potassium citrate group), and significantly
shorter than in the control group (14.0 days;
p<0.0001). These findings indicate that the
combined therapy not only enhances the ex-
pulsion rate but also accelerates the stone
passage process and may reduce patients’
pain duration.
Table 1. Comparison of patients’ general information.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment
group (n=25)
Control
group
(n=25)
-/χ²/F p
Age (years, mean ± SD) 43.2±11.8 41.7±12.5 42.8±12.1 42.1±12.7 0.25 0.87
Males (%) 68.0 64.0 68.0 64.0 0.18 0.98
BMI (kg/m², mean ± SD) 24.1±3.0 24.5±3.3 24.0±2.9 24.6±3.2 0.41 0.76
Stone size (mm, mean ± SD) 7.1±1.4 7.3±1.6 7.0±1.3 7.4±1.7 0.59 0.65
Upper segment (%) 28.0 24.0 28.0 24.0 0.21 0.98
Mid-range (%) 36.0 36.0 36.0 36.0 0.00 1.00
Lower segment (%) 36.0 40.0 36.0 40.0 0.17 0.98
CT values (HU, mean ± SD) 670±205 690±215 665±200 695±220 0.45 0.72
Blood creatinine (μmol/L) 77.8±17.5 79.2±18.8 78.0±17.9 79.1±19.0 0.16 0.91
Uric acid (μmol/L) 348±82 362±90 350±84 360±88 0.48 0.69
Urine pH (mean ± SD) 5.7±0.6 5.9±0.8 5.8±0.7 5.8±0.7 0.31 0.83
Hypertensive 16.0 12.0 16.0 16.0 - 1.00
Diabetes 8.0 12.0 12.0 12.0 - 1.00
Hyperuricemia 20.0 24.0 20.0 24.0 0.23 0.97
BMI: Body Mass Index, CT: Computed Tomography, HU: Hounsfield Unit, Combined treatment group: tamsulosin
+ potassium citrate. χ²: Chi-square Test, F: ANCOVA, -: Fisher exact. The p represents the overall difference across
the four groups (Tamsulosin, Potassium citrate, Combined treatment, and Control).
36 Liu et al.
Investigación Clínica 67(1): 2026
Comparison of efficacy by stone location
and composition
A comparison of efficacy based on stone
location and composition is shown in Table
3. The lower segment stone treatment group
achieved the best results, with an expulsion
rate of 91.2%, which was significantly higher
than the tamsulosin group (79.5%), the po-
tassium citrate group (73.2%), and the con-
trol group (58.6%). This difference was sta-
tistically significant (p<0.001), indicating
that the smooth muscle of the lower ureter
is more responsive to α-blockers like tamsu-
losin, and that combining potassium citrate
may further aid stone movement and disso-
lution. Upper segment stones had lower ex-
pulsion rates across all groups, with no sig-
nificant difference between them (p=0.12).
This suggests that upper stones are harder to
expel naturally due to their anatomical posi-
tion and gravity, and that medication alone
has limited effectiveness. More aggressive
treatments, such as extracorporeal lithotrip-
sy, might be necessary. The expulsion rate for
uric acid stones was notably higher in the po-
tassium citrate group (78.9%) compared to
the tamsulosin group (61.2%, p=0.03), and
increased further to 85.4% in the combina-
tion group. This indicates that urine alkalini-
zation with potassium citrate dissolves uric
acid stones, while tamsulosin has a weaker
mechanical effect on them. The clearance
rate of calcium stones was higher in the tam-
sulosin group (70.5%) than in the potassium
citrate group (55.8%), and reached 83.1% in
the combined group (p<0.01). This suggests
that calcium stones are resistant to dissolu-
tion and that tamsulosin helps promote their
passage by relaxing the ureter, whereas potas-
sium citrate has limited impact on them.
Analysis of safety results
The safety results are shown in Table
4, and there was no statistically significant
difference in adverse reactions (p>0.05).
No serious adverse reactions occurred. The
combination therapy group experienced a
higher rate of gastrointestinal adverse re-
actions, such as nausea (24%), vomiting
(16%), and abdominal pain (12%), com-
pared to other groups, indicating that the
drug combination may irritate the gastro-
intestinal tract. The occurrence of diarrhea
was significantly higher in the potassium ci-
trate group (16%) than in the other groups
(0-8%), with the p-value reaching statisti-
cal significance (p=0.05), suggesting that
potassium citrate may increase the risk of
diarrhea. The incidence of hypotension was
relatively higher in the tamsulosin group
(12%), but there was no significant differ-
ence compared to the other groups. The
rate of allergic reactions was low across all
groups, indicating a favorable safety profile.
Assessment of pain control effectiveness
As shown in Table 5, the first pain relief
time was shortest in the combination group,
Table 2. Comparison of outcomes of patients with spontaneous ureteral stone expulsion.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment
group (n=25)
Control
group
(n=25)
χ²/H p
4-week stone expulsion
rate (%) 68.2 62.1 84.6 46.3 15.72 <0.001
Median discharge interval
(days, 95% CI)
9.3
(8.1-10.5)
11.7
(10.2-13.2)
6.5
(5.8-7.2)
14.0
(12.5-15.5) 28.45 <0.0001
Combined treatment group: tamsulosin + potassium citrate. χ²: Chi-square Test, H: Kruskal-Wallis H. The p re-
presents the overall difference across the four groups (Tamsulosin, Potassium citrate, Combined treatment, and
Control).
Tamsulosin and potassium citrate in ureteral stone expulsion 37
Vol. 67(1): 30 - 44, 2026
taking only 4.8 hours, which was signifi-
cantly faster than the single-drug group (6.2
hours for tamsulosin and 7.5 hours for po-
tassium citrate) and the control group (9.3
hours). This difference was statistically sig-
nificant (p<0.01), indicating that the two-
drug combination had a synergistic analge-
sic effect. The frequency of pain episodes
was only 1.2 times per week in the combina-
tion therapy group, significantly lower than
the single-drug group (1.8 times for tamsu-
losin and 2.1 times for potassium citrate)
Table 3. Comparison of the efficacy of patients in terms of stone location and composition.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment
group (n=25)
Control
group
(n=25)
χ²p
Lower segment stones (%) 79.5 73.2 91.2 58.6 18.34 <0.001
Upper segment stones (%) 42.1 38.5 47.8 28.3 5.67 0.12
Uric acid stones (CT<500HU) (%) 61.2 78.9 85.4 42.9 9.12 0.03
Calcium stones (%) 70.5 55.8 83.1 47.2 13.45 <0.01
Combined treatment group: tamsulosin + potassium citrate. χ²: Chi-square Test. The p represents the overall diffe-
rence across the four groups (Tamsulosin, Potassium citrate, Combined treatment, and Control).
Table 4. Analysis of patient safety outcomes.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment group
(n=25
Control
group
(n=25)
χ²p
low blood pressure 3 (12%) 1 (4%) 2 (8%) 0 (0%) 3.21 0.36
nausea 4 (16%) 5 (20%) 6 (24%) 1 (4%) 5.78 0.12
vomiting 2 (8%) 3 (12%) 4 (16%) 1 (4%) 2.94 0.40
stomach pain 1 (4%) 2 (8%) 3 (12%) 0 (0%) 4.15 0.25
constipation 0 (0%) 4 (16%) 2 (8%) 0 (0%) 7.62 0.05
allergic reaction 1 (4%) 0 (0%) 1 (4%) 0 (0%) 2.04 0.56
Combined treatment group: tamsulosin + potassium citrate. χ²: Chi-square Test. The p-represents the overall diffe-
rence across the four groups (Tamsulosin, Potassium citrate, Combined treatment, and Control).
Table 5. Comparison of patients’ pain control outcome assessment.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment group
(n=25)
Control
group
(n=25)
F p
Time to first pain relief
(hours) 6.2±2.1 7.5±2.8 4.8±1.7 9.3±3.4 12.36 <0.01
Number of pain
episodes (times/week) 1.8±0.9 2.1±1.2 1.2±0.6 2.7±1.5 9.54 <0.05
Maximum VAS score
reduction (Δ) -3.5±1.2 -2.9±1.0 -4.2±1.4 -2.1±0.8 18.72 <0.001
VAS: Visual Analogue Scale. Combined treatment group: tamsulosin + potassium citrate. F: ANCOVA. The p re-
presents the overall difference across the four groups (Tamsulosin, Potassium citrate, Combined treatment, and
Control).
38 Liu et al.
Investigación Clínica 67(1): 2026
and the control group (2.7 times) (p<0.05).
This suggests that the combination therapy
can reduce the need for analgesic medica-
tion, improve patients’ quality of life, and
decrease emergency room visits. The im-
provement in pain intensity, measured by
the VAS score, was greatest in the combina-
tion therapy group (-4.2 points), which was
significantly better than the monotherapy
groups (tamsulosin -3.5 points, potassium
citrate -2.9 points) and the control group
(-2.1 points) (p<0.001). This indicates that
the combination therapy effectively reduces
pain intensity.
Comparison of imaging and laboratory
index assessment
A comparison of imaging and labora-
tory index assessments is shown in Table 6.
The stone movement distance was greatest
in the combined treatment group (12.3±4.1
mm), which was significantly better than
that in the single-drug group (8.7±3.2 mm
for tamsulosin and 6.5±2.8 mm for potassi-
um citrate) and the control group (4.2±2.1
mm) (p<0.001). This suggests that tamsu-
losin can relax the smooth muscle to widen
the ureter lumen, while potassium citrate
reduces crystalline deposits on the stone
surface; the combined treatment produces
a synergistic pro-excretory effect. The im-
provement rate of hydronephrosis in the
combined treatment group reached 78.2%,
significantly higher than in the single-drug
group (65.3% for tamsulosin and 58.7% for
potassium citrate) and the control group
(42.6%) (p<0.01). This reflects the relief
of ureteral obstruction, which can prevent
renal damage caused by long-term hydrone-
phrosis. Urinary citrate excretion increased
most notably in the potassium citrate and
combined groups (+142±38 mg/24h and
+158±42 mg/24h), significantly differing
from the control group (+8±5 mg/24h)
(p<0.001). Potassium citrate significantly
elevated urinary citrate levels. Renal func-
tion, assessed by creatinine, improved most
in the combined treatment group, with a
decrease of -18.6±7.2 μmol/L, which was
significantly better than the single-drug and
control groups (p<0.05). This indicates the
recovery of renal function after relief of ob-
struction, with the combination treatment
providing the most comprehensive protec-
tion for renal health.
Assessment of quality of life indicators
Quality of life indicators were evaluated
as shown in Table 7, and the most notable
enhancement was seen in the combined
Table 6. Comparison of patients’ imaging and laboratory index assessment.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment
group (n=25)
Control
group
(n=25)
χ²/F p
Stone travelling distance
(mm, CT) 8.7±3.2 6.5±2.8 12.3±4.1 4.2±2.1 24.73 <0.001
Improvement rate of
hydronephrosis (%) 65.3 58.7 78.2 42.6 14.28 <0.01
24-hour urinary citrate
(mg/24h, Δ) 25±12 142±38 158±42 8±5 32.15 <0.001
Decrease in serum
creatinine (μmol/L) -15.2±6.8 -12.7±5.9 -18.6±7.2 -8.3±4.1 12.34 <0.05
CT: Computed Tomography. Combined treatment group: tamsulosin + potassium citrate. χ²: Chi-square Test, F:
ANCOVA. The p represents the overall difference across the four groups (Tamsulosin, Potassium citrate, Combined
treatment, and Control).
Tamsulosin and potassium citrate in ureteral stone expulsion 39
Vol. 67(1): 30 - 44, 2026
treatment group (+0.28±0.09 points),
surpassing the single-drug groups (tamsu-
losin +0.21, potassium citrate +0.18) and
the control group (+0.12) (p<0.01). This
reflects overall improvement in pain man-
agement and activity levels. The quickest
recovery of daily activities occurred in the
combination therapy group (3.7±1.2 days),
which was 30-40% shorter than the single-
drug group (5.1 days for tamsulosin and 6.3
days for potassium citrate), and significant-
ly faster than the control group (7.5 days)
(p<0.001), indicating that the combination
therapy increases patient satisfaction with
treatment.
DISCUSSION
Ureteral stones are a common disease
of the urinary system, often leading to renal
colic, urinary tract obstruction, and infec-
tion, seriously affecting the quality of life of
patients 18. For stones with a small diameter
(usually<10 mm), conservative treatment
to promote their spontaneous expulsion is
the preferred clinical strategy, but the rate
of spontaneous stone expulsion is affected
by factors such as stone size, location, and
local inflammatory reaction in the ureter 19,
20. Potassium citrate may further synergize
with tamsulosin in stone expulsion rates.
Therefore, the aim of this study was to sys-
tematically evaluate the efficacy and safety
of tamsulosin and potassium citrate, alone
or in combination, on the spontaneous ex-
cretion of ureteral stones, and to provide
an evidence-based basis for optimal clinical
decision-making.
Ureteral stone is a common emergency
in the urinary system, this trial investigated
the differences in efficacy, action character-
istics and effects on different types of stones
between tamsulosin and potassium citrate
used alone and in combination, and system-
atically evaluated the differences in efficacy
between these two drugs in terms of stone
expulsion rate, time of expulsion, and pain
control through a controlled trial. The study
showed that the combination demonstrated
superior efficacy compared to both mono-
therapy and control groups in terms of the
main efficacy indicators (p<0.01). It was
further found that the combined treatment
was particularly effective in lower segment
stone discharge rate and uric acid stones. In
terms of safety, although the rate of adverse
reactions was slightly higher in the combina-
tion therapy group, it was dominated by mild
dizziness and gastrointestinal reactions, and
there was no significant increase in serious
adverse events. The results showed that the
combination of tamsulosin and potassium
citrate had a synergistic effect in promoting
stone expulsion, shortening the expulsion
time and relieving pain, and the efficacy was
significantly better than that of single-drug
treatment or natural stone expulsion.
The choice of therapeutic strategy for
ureteral stones requires a comprehensive
consideration of stone location and com-
positional characteristics 21. The efficacy of
pharmacological lithotripsy as an important
Table 7. Patients Comparison of quality of life indicators assessed.
Variables
Tamsulosin
group
(n=25)
Potassium
citrate group
(n=25)
Combined
treatment
group (n=25)
Control
group
(n=25)
p
EQ-5D-5L Scoring Improvement (Δ) 0.21±0.08 0.18±0.07 0.28±0.09 0.12±0.05 <0.01
Resumption of daily activities (days) 5.1±1.8 6.3±2.1 3.7±1.2 7.5±2.6 <0.001
EQ-5D-5L: Euro Qol 5-Dimensions 5-Levels, Combined treatment group: tamsulosin + potassium citrate. F: AN-
COVA. The p represents the overall difference across the four groups (Tamsulosin, Potassium citrate, Combined
treatment, and Control).
40 Liu et al.
Investigación Clínica 67(1): 2026
means of non-surgical treatment varies sig-
nificantly in patients with different anatomi-
cal locations and stone compositions 22. In
this study, we investigated differences in the
efficacy of these two drugs across patients
with varying stone characteristics. The re-
sults showed that stone location and com-
position significantly influenced the drugs’
effectiveness: in patients with lower-segment
stones, the combination therapy group had a
significantly higher expulsion rate than the
monotherapy and control groups (p<0.001),
confirming the specific effect of tamsulosin
on the lower ureteral segments; whereas,
in patients with upper-segment stones, the
efficacy in all groups was limited (combina-
tion group vs. control group, p=0.12), and
upper-segment stones may require surgical
intervention more often. Analysis of stone
composition revealed that potassium citrate
was significantly more effective in uric acid
stones (p=0.03), while tamsulosin was more
effective in calcium stones. Notably, the
combination treatments consistently main-
tained their superiority, indicating broad-
spectrum efficacy. These findings highlight
the importance of personalized treatment,
and clinical drug selection should consider
stone location and composition.
Drug safety assessment is a crucial as-
pect when choosing a treatment plan 23. In
pharmacological management of ureteral
stones, the safety profiles of tamsulosin and
potassium citrate, commonly used medi-
cations, need to be carefully evaluated 24.
Tamsulosin can cause side effects such as
postural hypotension and dizziness, while
potassium citrate, as an alkaline agent, may
lead to gastrointestinal discomfort and elec-
trolyte imbalances 25. The present study thor-
oughly examined the safety profiles of these
two drugs individually and in combination.
Results showed that gastrointestinal side ef-
fects like nausea, vomiting, and abdominal
pain were more common across all groups,
likely due to the side effects of both drugs.
Importantly, no serious adverse reactions
were observed, suggesting a favorable safety
profile for the combination therapy. These
findings indicate that although the combi-
nation may increase the frequency of minor
adverse reactions, it does not pose a risk of
serious adverse events.
Renal colic caused by urinary stones is
a common urological emergency, and rapid
pain relief along with a reduction in epi-
sode frequency are essential goals of clinical
treatment 26, 27. In this study, the analgesic ef-
fects of different treatment options were sys-
tematically assessed by measuring the time
to initial pain relief, the frequency of pain
episodes, and the reduction in VAS scores.
The time to first pain relief was significantly
shorter in the combination group compared
to the monotherapy and control groups, in-
dicating a synergistic analgesic effect of the
two drugs. The frequency of pain episodes
was significantly lower in the combination
treatment group than in the other groups
(p<0.05), suggesting that the combination
regimen not only provides quick pain relief
but also effectively prevents recurrent epi-
sodes. The combination group exhibited the
greatest improvement in pain levels, which
was significantly higher than that of mono-
therapy (p<0.001), further confirming the
analgesic benefit of combination therapy.
The combination of tamsulosin and potas-
sium citrate offers notable advantages in
managing pain associated with urinary tract
stones, providing faster relief and more sus-
tained reduction in both the frequency and
severity of pain episodes 28.
The assessment of treatment efficacy
of urinary tract stones needs to consider
not only the stone expulsion rate, but also
focus on comprehensive factors such as
stone mobility, improvement of renal func-
tion and changes in urinary biochemical
indexes 29, 30. In the present investigation,
we comprehensively evaluated the effects
of different treatment regimens on stone
kinetics and renal function using objec-
tive indicators, including stone mobility
distance measured by CT, improvement in
hydronephrosis, changes in 24-hour urinary
Tamsulosin and potassium citrate in ureteral stone expulsion 41
Vol. 67(1): 30 - 44, 2026
citrate, and decreases in serum creatinine.
Stone movement distance: the combined
treatment group showed the greatest stone
movement, which was significantly greater
than the single-drug group (p<0.001), con-
firming that the combination of the two
drugs synergistically enhanced stone mo-
bility. Improvement of hydronephrosis: the
highest improvement rate was observed in
the combination group (p<0.01), suggest-
ing that the combination therapy could
more effectively relieve urinary tract ob-
struction. Change in urinary citrate: uri-
nary citrate increased significantly in the
potassium citrate and combination groups,
reflecting the pharmacodynamic effect of
potassium citrate. Renal function improve-
ment: Serum creatinine decreased most
significantly in the combination group,
showing its advantage in protecting re-
nal function. The study confirms that the
combined treatment of tamsulosin and po-
tassium citrate has a synergistic effect in
promoting stone movement, improving hy-
dronephrosis, and protecting renal function
31, which provides an objective basis for the
clinical combined drug regimen. In particu-
lar, the combination group was significantly
better than monotherapy across all indica-
tors, suggesting that combination therapy
may be a better choice for patients who re-
quire stone expulsion while improving the
urinary environment and renal function.
The outcome of treatment for urinary
stones requires not only objective clinical
indicators, but also patient-reported out-
comes (PROs) and quality of life improve-
ment 32, 33. The EQ-5D-5L, an internation-
ally recognized quality-of-life assessment
tool, provides a comprehensive picture of
the patient’s health status across five di-
mensions: mobility, self-care, activities of
daily living, pain and discomfort, and anxi-
ety and depression 34. Meanwhile, the time
to resume daily activities is an important
indicator for assessing the impact of treat-
ment on patients’ social functioning 35.
This study assessed the impact of different
treatment regimens on patients’ overall re-
covery through these two patient-centered
outcome indicators. Improvement in EQ-
5D-5L scores: the combination therapy
group showed the greatest improvement in
quality of life and demonstrated superior
efficacy compared with both monotherapy
and control groups (p<0.01), suggesting
that combination therapy has a synergistic
advantage in improving patients’ overall
health status. The study results confirmed
that combination therapy with tamsulo-
sin and potassium citrate significantly im-
proved patients’ quality of life and acceler-
ated functional recovery. This advantage
may stem from the fact that tamsulosin
relieves pain symptoms faster, potassium
citrate improves the urinary environment
to reduce discomfort, and the synergistic
effect of the two drugs shortens the overall
recovery process.
In conclusion, for ureteral wall stones
measuring ≤10 mm, the combination treat-
ment was more effective than tamsulosin
alone, without a significant increase in ad-
verse drug reactions. The combination of
tamsulosin and potassium citrate notably
improved the stone expulsion rate for these
stones and therefore warrants further clini-
cal observation and research. Although cur-
rent evidence supports the effectiveness of
tamsulosin and potassium citrate in promot-
ing spontaneous ureteral stone expulsion,
this study has several limitations a lack of
validation through large-scale, multicenter
randomized controlled trials (RCTs), affect-
ing the reliability of the findings. Moving
forward, larger, more rigorous studies are
needed, along with standardized efficacy cri-
teria and extended follow-up periods to bet-
ter establish its clinical value.
Acknowledgment
None.
Funding
None.
42 Liu et al.
Investigación Clínica 67(1): 2026
Consent to publish
The manuscript has neither been previ-
ously published nor is under consideration
by any other journal. The authors have all ap-
proved the content of the paper.
Consent to participate
We secured a signed informed consent
form from every participant.
Ethic approval
The study strictly followed the require-
ments of the Declaration of Helsinki and
the ethical guidelines of Wuxing District
People’s Hospital of Huzhou City and was ap-
proved by this Hospital’s Ethics Committee
# 2025LW003).
Data availability statement
The data supporting the findings of this
study are available from the corresponding
author upon request.
ORCID numbers of authors
• Lihua Liu (LL):
0009-0006-9873-2323
• Kai Zhang (KZ):
0009-0002-7817-1048
• Daichang Li (DL):
0009-0006-4532-0931
Author contribution
LL: Conceived and designed the re-
search, and analyzed data. Drafted and re-
vised the manuscript critically for important
intellectual content. KZ: Contributed to the
acquisition, analysis, and interpretation of
data. Provided substantial intellectual input
during the drafting and revision of the man-
uscript. DL: Participated in the conception
and design of the study. Played a key role in
data interpretation and manuscript prepara-
tion. All authors have read and approved the
final version of the manuscript.
Conflicts of interest
The authors affirm that they have no fi-
nancial conflicts of interest.
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