Affiliations
doi: 10.29271/jcpsppg.2025.01.117ABSTRACT
Objective: To assess the efficacy of tamsulosin as an adjuvant medical therapy after extracorporeal shock wave lithotripsy (ESWL) for renal stones.
Study Design: A descriptive cross-sectional study.
Place and Duration of the Study: Department of Urology, Institute of Kidney Diseases, Peshawar, Pakistan, from January to July 2024.
Methodology: A total of 194 patients presenting with renal stones were observed to determine the efficacy of tamsulosin. A complete history, physical examination, and investigations such as urinalysis, blood urea, serum creatinine, plain x-ray of the kidney ureter and bladder (KUB), and ultrasound KUB were recorded for each patient. All patients underwent ESWL and were subsequently prescribed tamsulosin 0.4 mg once daily and diclofenac 50 mg twice daily for four weeks. Tamsulosin was considered effective if spontaneous passage of the ureteric stone occurred within four weeks of starting therapy, confirmed by the absence of a stone on ultrasound KUB and plain x-ray KUB. Data were analysed using SPSS.
Results: The study included 194 patients. Of these, 118 (60.8%) were men and 76 (39.2%) were women. The majority of patients (n = 142, 73.2%) were aged 31–55 years, followed by 52 (26.8%) aged 18–30 years. Tamsulosin was effective in 124 (63.9%) patients, and its efficacy did not differ significantly by age, gender, stone location, or stone size.
Conclusion: Tamsulosin is an effective adjuvant therapy for renal stones after ESWL, with a stone expulsion rate of 63.9%.
Key Words: Efficacy, Tamsulosin, ESWL, Renal stones, Medical expulsive therapy, Stone clearance.
INTRODUCTION
Urolithiasis is a common urological condition characterised by the formation of crystal aggregates that may pass through the urinary tract. The term urolithiasis is derived from the Greek words uro (urinary) and lithos (stone). Renal stones were first documented in the ancient Mesopotamian medical texts dating back to 3200–1200 BC.1 Urolithiasis affects 1–20% of the global population and is becoming increasingly prevalent worldwide, creating a considerable health burden across all age groups and underscoring the need for effective public health strategies to address this disease.2 Approximately 22% of urolithiasis cases occur in the ureters. Urolithiasis develops when solutes crystallise out of urine to form calculi.
The condition may result from anatomical abnormalities causing urinary stasis, reduced urine volume, dietary factors such as excessive oxalate or sodium intake, urinary tract infection, systemic acidosis, pharmacological agents, or, more rarely, inherited genetic disorders, such as cystinuria.3 Each year, more than one million people seek Accident and Emergency (A&E) care for acute renal colic and kidney stones, with about 20% requiring hospital admission.4,5 To tailor the treatment, a full medical history, clinical examination, and laboratory and radiographic investigations are required.6
Extracorporeal shock wave lithotripsy (ESWL) has been consi- dered a cornerstone in the treatment of renal and ureteric stones since 1984.7 It is currently one of the most recommended treatment options for small- and medium-sized stones in most guidelines and is regarded as the preferred treatment by the National Institute for Health and Care Excellence (NICE) in the United Kingdom.8 Nonetheless, a significant proportion of patients have an unsatisfactory stone-free rate following ESWL. It pulverises hard concretions, such as urinary stones, into small, passable fragments using external equipment that generates intense pressure waves.9 This method is notable for its non-invasive nature, which allows shock waves to pass through body tissues, focuses energy on the stone and reduces patient distress while enabling faster recovery.10
ESWL is contrasted with alternative stone treatment methods, particularly ureteroscopy, to emphasise its minimal invasiveness, greater patient tolerance, and cost-effectiveness. Furthermore, by highlighting the integrated healthcare team's joint efforts in patient assessment and care, this approach improves comprehension and competency in delivering ESWL, resulting in better outcomes for patients with nephrolithiasis.11 Further study of the adjuvant therapy to improve this outcome is required.12 Previous studies have demonstrated that tamsulosin, an α₁-adrenergic receptor antagonist, can facilitate stone passage and shorten the duration of stone expulsion.13 Tamsulosin, in combination with ESWL, has been shown to improve stone expulsion in patients with larger renal stones, whereas in those with ureteric stones, it mainly reduces painful episodes. The role of tamsulosin in the management of ureteric and renal calculi needs to be established through larger prospective trials.14
In a study by Hashem et al., patients with renal stones underwent outpatient ESWL, followed by analgesics and oral tamsulosin (0.4 mg/day) for three months or until they became stone-free.15 In a study by Maldonado-Valadez et al.,16 individuals with renal stones underwent an outpatient ESWL procedure, followed by analgesics and oral tamsulosin (0.4 mg once daily) for eight weeks. Tamsulosin demonstrated an efficacy of 53.57%. In another study, individuals with renal stones underwent three sessions of ESWL. Subsequently, oral tamsulosin (0.4 mg/day) was administered for one day following each session. Tamsulosin had an efficacy rate of 94.1%.17
Due to the inconsistent findings in previous studies and the lack of a clear clinical consensus on the optimal dose and duration of tamsulosin, further investigation is required on its role in increasing the stone clearance rate after ESWL.
The study aimed to address this knowledge gap by evaluating the efficacy of tamsulosin as an adjuvant medical therapy after ESWL for renal stones.
METHODOLOGY
The descriptive cross-sectional study was conducted at the Department of Urology, Institute of Kidney Diseases, Peshawar, Pakistan, from January to July 2024. Ethical approval was obtained from the Research Committee of the Institute of Kidney Diseases, Peshawar, Pakistan (Ref. No. 294; dated 16 January 2024). A consecutive non-probability sampling technique was employed for sample collection. The sample size was estimated using the WHO sample size calculator, based on a 53.57%16 efficacy of tamsulosin in renal stone expulsion after ESWL, with a 95% confidence level and a 7% margin of error. Thus, the total sample size was 194 patients. All symptomatic patients of both genders, presenting with a single radio-dense renal calculus (5-20 mm) on abdominopelvic ultrasound and aged 18–55 years, were included. Patients with a serum creatinine level greater than 2.0 mg/dl, lower pole or radiolucent stones, distal obstruction, previously failed ESWL, diabetes mellitus, concurrent use of calcium channel blockers, a history of renal tract surgery, major vertebral abnormalities, morbid obesity, pregnancy, renal artery or aortic aneurysm, clotting disorders, or a ureteric stent were excluded. Patients were enrolled through the outpatient, emergency, and inpatient units of the Department of Urology, Institute of Kidney Diseases, Peshawar, Pakistan, after obtaining informed consent. A detailed history, physical examination, plain x-ray KUB, and ultrasound KUB were performed to confirm the presence of renal stones. All included patients underwent ESWL and were subsequently prescribed tamsulosin 0.4 mg once daily and diclofenac sodium 50 mg twice daily for four weeks, with weekly follow-up maintained throughout this period. Tamsulosin therapy was discontinued upon stone passage or at the end of the fourth week. Any adverse effects occurring during this period were recorded. Treatment with tamsulosin was considered effective if spontaneous passage of the ureteric stone occurred within four weeks of therapy initiation after ESWL, as confirmed by the absence of the ureteric stone on x-ray KUB and ultrasound KUB.
Data were analysed using the Statistical Package for Social Sciences (SPSS). The mean and standard deviation (SD) were computed for age, stone size, and expulsion time. Frequencies and percentages were computed for gender, stone location (left or right), and efficacy of tamsulosin. The efficacy of tamsulosin was stratified by effect modifiers such as age, gender, stone location, and stone size to assess effect modification. A post- stratification Chi-square test was applied, with a p ≤0.05 considered significant.
RESULTS
In the present study, 194 patients underwent ESWL for the treatment of renal stones. Of these, 118 (60.8%) were men and 76 (39.2%) were women. The majority of patients (n = 142, 73.2%) were aged 31–55 years, followed by 52 (26.8%) aged 18–30 years. The mean age was 38 ± 7.167 years. One hundred and fourteen (58.8%) patients had a radio-dense renal stone on the left side, while 80 (41.2%) had a stone on the right side. A total of 132 (68%) patients had a stone size of ≤10 mm, and 62 (32%) had a stone size of >10 mm (mean stone size: 10.24 ± 2.348 mm). Stone expulsion occurred within 30 days in 124 (63.9%) patients and after 30 days in 70 (36.1%) patients. Tamsulosin was effective in 124 (63.9%) patients. Moreover, the efficacy of tamsulosin did not differ significantly by gender, age, stone size, or stone side (p >0.05, Table I).
DISCUSSION
The age and gender characteristics of this study are consistent with the established epidemiology of renal stones, which are most common in middle-aged adults due to metabolic, nutritional, and lifestyle factors. A male predominance (n = 118, 60.8%) was observed, which is consistent with global trends indicating that males are more prone to urolithiasis, likely due to hormonal factors, higher body mass index (BMI), and dietary habits.
Table I: Association of patient demographics and stone characteristics with the efficacy of tamsulosin in renal stone management (n = 194).
|
Variables |
Frequency and percentages |
Mean ± SD |
Efficacy of tamsulosin |
Total |
*p-values |
|
|
Effective n = 124 (63.9%) |
Not effective n = 70 (36.1%) |
|||||
|
Age (years) |
|
|
|
|
|
|
|
18-30 years |
52 (26.8%) |
38 ± 7.167 years |
31 (25%) |
21 (30%) |
52 (26.8%) |
0.450 |
|
31-55 years |
142 (73.2%) |
93 (75%) |
49 (70%) |
142 (73.2%) |
|
|
|
Total |
194 (100%) |
124 (100%) |
70 (100%) |
194 (100%) |
||
|
Gender |
|
|
|
|
|
|
|
Male |
118 (60.8%) |
-- |
79 (63.7%) |
39 (55.7%) |
118 (60.8%) |
0.273 |
|
Female |
76 (39.2%) |
45 (36.3%) |
31 (44.3%) |
76 (39.2%) |
|
|
|
Total |
194 (100%) |
124 (100%) |
70 (100%) |
194 (100%) |
||
|
Stone side |
|
|
|
|
|
|
|
Left |
114 (58.8%) |
-- |
78 (62.9%) |
36 (51.4%) |
114 (58.8%) |
0.119 |
|
Right |
80 (41.2%) |
46 (37.1%) |
34 (48.6%) |
80 (41.2%) |
|
|
|
Total |
194 (100%) |
124 (100%) |
70 (100%) |
194 (100%) |
||
|
Size of stone |
|
|
|
|
|
|
|
≤10 mm |
132 (68%) |
10.24 ± 2.34 mm |
87 (70.2%) |
45 (64.3%) |
132 (68%) |
0.399 |
|
>10 mm |
62 (32%) |
37 (29.8%) |
25 (35.7%) |
62 (32%) |
|
|
|
Total |
194 (100%) |
124 (100%) |
70 (100%) |
194 (100%) |
||
|
Expulsion time |
|
|
|
|
|
|
|
≤30 days |
124 (63.9%) |
31.21 ± 6.03 days |
124 (100%) |
0 (0%) |
124 (63.9%) |
0.000 |
|
>30days |
70 (36.1%) |
0 (0%) |
70 (100%) |
70 (36.1%) |
|
|
|
Total |
194 (100%) |
124 (100%) |
70 (100%) |
194 (100%) |
|
|
|
*Chi-square test was applied. |
||||||
Similarly, the size and laterality of stones were also consistent with previous studies. Similar findings were observed by Ahmed et al., in which the mean age was 46.72 ± 12.71 years.18 Men constituted the majority of the cohort (65.83%), followed by women (34.17%). The mean serum creatinine level was 0.90 ± 0.16 mg/dl, and the mean kidney stone size was 1.55 ± 0.68 cm. Patients experienced stone disease for an average of 3.63 ± 1.90 months. The renal pelvis contained the highest proportion of stones (55.83%), followed by the lower calyx (23.33%), middle calyx (17.50%), and upper calyx (3.33%).
The present study showed that tamsulosin was effective in 124 (63.9%) patients, suggesting that its mechanism as an α₁-adrenergic receptor blocker reduces ureteric spasm and facilitates stone passage, thereby aiding faster stone clearance in most cases. Maldonado-Valadez et al. evaluated 57 patients, with 28 in the tamsulosin group and 29 in the control group.16 The mean stone diameter was 11.42 ± 4.52 mm. The overall stone clearance rate was 50.88% (29 of 57), with 53.57% (15 of 28) in the tamsulosin group and 48.27% (14 of 29) in the control group (p = 0.680). According to Shahzad et al., the tamsulosin group had a higher stone clearance rate (80% vs. 60%, p <0.05) and a shorter stone expulsion time (mean difference: -3 days, 95% CI: -5 to -1, p <0.05) compared to the control group.17 Complications were minimal and did not differ significantly between the groups. Ahmed et al. reported that stone clearance occurred in 109 patients (90.83%), with 58 (96.6%) in the study group (tamsulosin) and 51 (85.0%) in the control group (standard treatment).18 The difference was statistically significant (p = 0.027), indicating that the study group had a higher stone clearance rate than the control group. Osman et al. observed a stone clearance rate of 86.9% (20 patients) in the placebo group and 92.5% (25 patients) in the tamsulosin group, with no statistically significant difference (p = 0.20).19 Another study by Shaikh et al. reported that patients had a mean age of 31.29 ± 9.06 years.20 Among 160 patients, 61 (38.1%) were women and 99 (61.9%) were men. The stone clearance rate was 90.6%. The stone clearance rate with tamsulosin 0.4 mg was significantly higher than without it (93.8% vs. 62.5%; p = 0.0005).
The results of the present study showed that tamsulosin was effective and showed no significant difference across patients of different age groups, gender, stone locations, or stone sizes (p >0.05), implying that its benefits may be broadly applicable across different patient subgroups. This contrasts with previous research, which found that stone size and location were major predictors of medical expulsive therapy efficacy. This disparity could be attributed to differences in study populations, stone composition, or ESWL fragmentation efficiency. Similar results were reported by Ahmed et al., who found no significant difference in stone clearance rates among patients aged 18–49 years (p = 0.168).18 However, individuals aged 50 to 70 years demonstrated a trend towards higher stone clearance in the study group (p = 0.053). Gender stratification revealed a significantly higher stone clearance rate among men who received tamsulosin (p = 0.030), while no significant difference was observed among women (p = 0.360).
This study emphasises that the use of adjuvant tamsulosin is important for improving stone clearance. The use of tamsulosin as an adjuvant therapy for renal stones could be a simple and effective way to enhance the outcomes of ESWL.
There were some limitations to the present study, the most important being the relatively small sample size of 194 patients, the short duration of six months, and its single- centre design. Future research should be conducted with larger sample sizes in multiple hospitals with a study period of at least one year to obtain more accurate results. Future studies should also include effect modifiers such as obesity, hypertension, and diabetes to evaluate the impact of tamsulosin therapy in these patients. Furthermore, research on the cost-effectiveness of tamsulosin as adjuvant therapy and on the effects of patient adherence to treatment may provide crucial information for clinical practice.
CONCLUSION
Tamsulosin is an effective treatment for stone clearance after ESWL. Its consistent performance across patient groups makes it a beneficial adjunct in the management of renal calculi, particularly those measuring ≤10 mm. Tamsulosin may reduce the burden of kidney stones on healthcare systems and improve patients’ quality of life by increasing the rate of stone clearance and shortening the time required for stone passage.
ETHICAL APPROVAL:
Ethical approval was obtained from the Research Committee of the Institute of Kidney Diseases, Peshawar, Pakistan (Ref. No. 294; Dated 16 January 2024).
PATIENTS’ CONSENT:
Informed consent was obtained from all participants in this study to publish the data.
COMPETING INTEREST:
The authors declared no conflict of interest.
AUTHORS’ CONTRIBUTION:
MH: Data acquisition, analysis, interpretation, drafting, and integrity of the work.
MAS: Reviewed critical appraisal and approval.
Both authors approved the final version of the manuscript to be published.
REFERENCES