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World J Crit Care Med. Jun 9, 2026; 15(2): 114619
Published online Jun 9, 2026. doi: 10.5492/wjccm.v15.i2.114619
Extracorporeal shockwavelithotripsy vs ureteroscopy for management of acute ureteric colic due to stones: A randomized controlled trial
Jaydeep Jain, Shiv C Navriya, Ravi Chandra Chintapalli, Gautam R Choudhary, Mahendra Singh, Deepak P Bhirud, Arjun S Sandhu, Department of Urology, All India Institute of Medical Sciences, Jodhpur 342008, Rājasthān, India
ORCID number: Jaydeep Jain (0000-0002-0697-7619); Shiv C Navriya (0000-0003-4859-3979); Ravi Chandra Chintapalli (0009-0005-2869-7086); Gautam R Choudhary (0000-0003-0533-6227); Mahendra Singh (0000-0001-8769-8269); Deepak P Bhirud (0000-0003-3908-4275).
Co-corresponding authors: Shiv C Navriya and Ravi Chandra Chintapalli.
Author contributions: Jain J, Navriya SC, and Chintapalli RC made substantial contributions to the acquisition and interpretation of data, contributed to the study concept; Navriya SC and Chintapalli RC contributed equally to this article, they are the co-corresponding authors of this manuscript; Navriya SC, Choudhary GR, Singh M, and Bhirud DP critically reviewed the manuscript; Chintapalli RC, Singh M, and Bhirud DP agreed to be accountable for all aspects of the work; and all authors have read and approved the final manuscript.
AI contribution statement: AI tools (specifically ChatGPT and Grammarly) were used solely for linguistic refinement and formatting assistance. No AI tool was involved in the generation of research data, interpretation of results, or formulation of conclusions. All AI-generated outputs were critically reviewed and revised by the authors.
Institutional review board statement: This study was approved by the Medical Ethics Committee of All India Institute of Medical Sciences, approval No. ALLMS/IEC/2023/9514.
Clinical trial registration statement: This study was approved by All India Institute of Medical Sciences, approval No. CTRI/2024/12/078043.
Informed consent statement: The patient has given informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Data can be shared.
Corresponding author: Shiv C Navriya, Adjunct Associate Professor, Consultant, Department of Urology, All India Institute of Medical Sciences, Faculty Quarters, Jodhpur 342008, Rājasthān, India. drshivnavriya2004@gmail.com
Received: September 24, 2025
Revised: November 11, 2025
Accepted: February 2, 2026
Published online: June 9, 2026
Processing time: 239 Days and 14.3 Hours

Abstract
BACKGROUND

Urolithiasis is one of the most prevalent condition with evolving management strategies. While extracorporeal shock wave lithotripsy (ESWL) and ureteroscopic lithotripsy (URSL) are common minimally invasive treatments, their comparative efficacy, safety, and impact on quality of life (QoL) require continuous evaluation.

AIM

To compare the clinical efficacy, safety, patient satisfaction, and economic outcomes of ESWL vs URSL in the management of lower ureteric stones.

METHODS

This randomized controlled trial included 240 adult patients with confirmed lower ureteric calculi, allocated equally to ESWL or URSL groups. Baseline characteristics, stone parameters, procedural details, complications, and follow-up outcomes - including stone clearance, pain, QoL, workdays lost, cost, and satisfaction - were systematically analyzed over a 3-month follow-up.

RESULTS

URSL demonstrated significantly higher stone-free rates at all time points (e.g., 95% at 3 months) compared to ESWL (55.83%). While ESWL was associated with fewer complications, it required more sessions and resulted in lower immediate postoperative QoL and higher workdays lost. Conversely, ESWL was more cost-effective and highly satisfactory, with better early pain scores. Stone size and density influenced success, favoring URSL for larger or denser stones. Overall, both modalities are effective, but treatment choice should be individualized based on stone characteristics and patient factors.

CONCLUSION

URSL offers superior stone clearance, particularly for larger stones, with acceptable safety profiles. ESWL remains a viable non-invasive option for smaller stones, providing better QoL recovery and economic benefits. Individualized treatment planning is essential for optimal outcomes.

Key Words: Acute renal colic; Lower ureteric calculi; Ureteroscopic lithotripsy; Extracorporeal shock wave lithotripsy; Stone-free rate; Cost-effectiveness; Quality of life; Complications

Core Tip: Management of acute colic due to lower ureteric calculi requires balancing stone clearance, patient comfort, and treatment costs. Ureteroscopic lithotripsy achieves higher stone-free rates and patient satisfaction, especially in larger or complex stones, whereas extracorporeal shock wave lithotripsy remains a less invasive, cost-effective option suitable for smaller stones. Treatment should therefore be individualized, considering stone characteristics, patient preferences, and resource availability.



INTRODUCTION

Urinary stone disease is among the oldest known ailments, with evidence from a 5000-year-old Egyptian mummy and early records in Mesopotamia and India. The ancient Indian text Sushruta Samhita (600 BCE) described surgical techniques like perineal lithotomy and emphasized dietary/Lifestyle links - principles still echoed in modern metabolic theories. Sushruta’s practices influenced global surgical traditions. In the medieval period, Islamic scholars like Albucasis refined lithotomy techniques, culminating in Jacques de Beaulieu’s Renaissance-era lateral lithotomy[1,2]. The 19th century introduced Jean Civiale’s lithotripsy, reducing surgical trauma. The 20th century saw breakthroughs with extracorporeal shock wave lithotripsy (ESWL) and ureteroscopic lithotripsy (URSL), which emphasized minimally invasive ureteric stone management. Ureteric stones are prevalent worldwide, commonly lodging at the ureteropelvic junction, pelvic brim, and uretero vesical junction, causing obstruction and severe colicky pain. Symptoms include flank pain, hematuria (up to 90%), nausea, vomiting, and lower urinary tract symptoms. Non-contrast computed tomography (NCCT) kidney ureter blader (KUB) remains the diagnostic gold standard, with ultrasound and X-ray KUB as supportive tools[3]. Spontaneous passage depends on size/Location < 5 mm stones pass in 68%-85%, 5-7 mm in 47%-60%. Stones > 7 mm or persisting > 4-6 weeks often require intervention. ESWL is non-invasive, ideal for stones < 10 mm and Hounsfield units (HU) < 1000, with 40%-90% success. It’s cost-effective and outpatient-suited but less effective for larger/harder stones. α-blockers enhance post-ESWL clearance[4]. URSL, the gold standard for lower ureteric stones, has 85%-95% stone-free rates. Using lasers and baskets, it handles all stone types, including complex/refractory ones. Although more invasive and requiring anesthesia and stenting, URSL excels in difficult cases, including in pregnancy and coagulopathies[5]. Despite both being viable, URSL shows higher success but greater morbidity; ESWL is less invasive with lower cost. Optimal modality choice hinges on stone/patient factors and resource availability. Globally, urolithiasis affects 1%-13%, with rising incidence in Asia due to urbanization and dietary shifts. India saw 25 million new cases in 2019, mostly in males aged 20-40[6-9]. Environmental risks (heat, low hydration) and reliance on ultrasonography exacerbate the burden. Economically, the United States spends over $2 billion annually[8]. In India, limited access to ESWL/URSL inflates indirect costs. Clinical presentations include renal colic, hematuria, and dysuria[10], with NCCT KUB preferred for acute cases[11]. Spontaneous passage rates: < 5 mm (75%), ≥ 5 mm (62%)[12-14]. Observation or medical expulsion therapy (e.g., α-blockers) is recommended up to 6 weeks, especially for distal stones > 5 mm[11,15]. Treatment selection considers stone features and anatomy. While ESWL is less invasive, URSL yields superior stone-free rates (SFRs), especially for larger/complex stones[11,15]. Studies show URSL superiority: 96.4% SFR vs 64% for ESWL[16]; other findings echo this but note higher ureteral injuries with URSL[17-23]. Cost-effectiveness diverges by size: ESWL is economical for < 10 mm stones[24], while URSL suits > 10 mm stones[25,26]. Despite URSL’s efficacy, its costs and complications deter first-line use for small stones. In India, the absence of randomised control trails on patient satisfaction and access highlights the need for localized research to inform care models[24-26].

MATERIALS AND METHODS

This randomized controlled trial was conducted over 24 months (January 2023-December 2024) at the Department of Urology, All India Institute of Medical Sciences, India. Patients presenting with lower ureteric calculi during this period were enrolled.

Inclusion criteria

Inclusion criteria including: (1) Lower ureteric stone confirmed via NCCT KUB; (2) Need for active intervention; (3) Age ≥ 18 years; (4) Eligibility for either ESWL or URSL; and (5) Willingness to participate.

Exclusion criteria

Exclusion criteria including: (1) Inability to provide consent; (2) Active urinary tract infection; (3) Pregnancy; (4) Uncontrolled hypertension or bleeding; (5) Severe skeletal or vascular malformations; (6) Inability to assume treatment position; and (7) Solitary or transplanted kidneys.

Eligible patients received a Patient Information Leaflet and signed informed consent. After diagnosis confirmation through clinical exam, labs, and imaging, participants were assigned unique study IDs. Randomization was done using block randomization (Sealed Envelope Ltd) into: Group A: ESWL and group B: URSL.

Group A (ESWL) patients were scheduled for treatment at the ESWL suite. Group B (URSL) patients underwent pre-anesthetic checks and were scheduled for surgery based on operation room availability.

Data collection parameters

(1) Demographics: Age, sex, comorbidities; (2) Stone characteristics: Laterality, size, diameter, HU; and (3) Labs: Complete blood count, kidney function test, urine culture.

Procedural details

Group A (ESWL): Energy delivered, shock count, suite time, focusing modality, patient/ESWL head position, clearance status, sessions needed (max 2).

Group B (URSL): Lithotripsy time, double J stent presence/placement, hospital stay, technical difficulties.

Pain and analgesia

Visual Analog Scale (VAS) scores: Pre, post, 1 week, 8 weeks. Analgesic use at same time points.

Complications

Documented and graded per Clavien-Dindo classification.

Outcome measures

Stone clearance, need for further intervention, workdays lost.

Follow-up assessments

Imaging (X-ray KUB) to confirm stone-free status. Data via Google Forms: Workdays lost, cost incurred; satisfaction/acceptability (5-point Likert); EQ-5D-5 L responses. Participants remained in the trial until withdrawal, clinical inability to continue, or completion of 3-month follow-up. Non-responders to two ESWL sessions were offered URSL as definitive therapy.

RESULTS

Compared to group B, group A had comparable distribution of age. mean ± SD age was 35.89 ± 10.09 years in group A vs 36.08 ± 13.45 years in group B, with no significant difference between them (P value = 0.901) (Table 1, Figure 1).

Figure 1
Figure 1 Comparison of age, blood investigations, urine culture, and stone length. A: Comparison of age between group A and B; B: Comparison of blood investigations between group A and B; C: Comparison of urine culture between group A and B; D: Comparison of stone length between group A and B.
Table 1 Comparison of age between group A and B, n (%).
Age
Group A (n = 120)
Group B (n = 120)
Total
P value
18-20 years4 (3.33)9 (7.50)13 (5.42)0.109
21-30 years39 (32.50)44 (36.67)83 (34.58)0.109
31-40 years46 (38.33)31 (25.83)77 (32.08)0.109
41-50 years20 (16.67)16 (13.33)36 (15)0.109
51-60 years8 (6.67)14 (11.67)22 (9.17)0.109
61-70 years1 (0.83)5 (4.17)6 (2.50)0.109
71-80 years2 (1.67)1 (0.83)3 (1.25)0.109
mean ± SD35.89 ± 10.0936.08 ± 13.4535.99 ± 11.860.901
Median (25th-75th percentile)33.5 (29-41)33 (26.75-45)33 (28-42.25)0.901
Range19-7818-8018-800.901

Group A and group B showed statistically comparable gender distributions; however, there was a male predominance, with an approximate male-to-female ratio of 1.8:1 in group A (64.17% males vs 35.83% females) and 2.3:1 in group B (70.00% males vs 30.00% females). No statistically significant difference was observed (P = 0.336) (Table 2).

Table 2 Comparison of gender between group A and B, n (%).
Gender
Group A (n = 120)
Group B (n = 120)
Total
P value
Female43 (35.83)36 (30)79 (32.92)0.336
Male77 (64.17)84 (70)161 (67.08)0.336
Total120 (100)120 (100)240 (100)0.336

Group A had a higher proportion of patients with right-sided involvement compared to group B (53.33% vs 39.17%) and a lower proportion with left-sided involvement (46.67% vs 60.83%) (P = 0.098) (Table 3).

Table 3 Comparison of side between group A and B, n (%).
Side
Group A (n = 120)
Group B (n = 120)
Total
P value
Left56 (46.67)73 (60.83)129 (53.75)0.098
Right64 (53.33)47 (39.17)111 (46.25)0.098
Total120 (100)120 (100)240 (100)0.098

Compared to group B, group A had comparable distribution of comorbidities: Hypertension (21.67% in group A vs 30% in group B, P value = 0.14), diabetes mellitus (25.83% vs 19.17%, P value = 0.216) and hypothyroidism (0.83% vs 1.67%, P value = 1) (Table 4).

Table 4 Comparison of comorbidities between group A and B, n (%).
Comorbidities
Group A (n = 120)
Group B (n = 120)
Total
P value
Hypertension26 (21.67)36 (30)62 (25.83)0.14
Diabetes mellitus31 (25.83)23 (19.17)54 (22.50)0.216
Hypothyroidism1 (0.83)2 (1.67)3 (1.25)1

The baseline characteristics of group A and group B were comparable. No significant differences were observed in blood investigations, including hemoglobin (11.29 ± 1.96 g/dL vs 11.37 ± 1.85 g/dL, P = 0.735), serum urea (22.13 ± 10.41 mg/dL vs 23.02 ± 10.7 mg/dL, P = 0.517), and serum creatinine (0.9 ± 0.33 mg/dL vs 0.93 ± 0.34 mg/dL, P = 0.446) (Figure 2). Similarly, urine culture results were nearly identical, with no growth in 100% of group A and 99.17% of group B (P = 1) (Figure 1).

Figure 2
Figure 2 Comparison of stone diameter, stone Hounsfield units, comparison of stone clearance, and complications. A: Comparison of stone diameter between group A and B; B: Comparison of stone Hounsfield units between group A and B; C: Comparison of stone clearance between group A and B; D: Comparison of complications between group A and B. HU: Hounsfield units.

Stone-related factors were comparable between group A and group B. The mean ± SD stone length was 15.97 ± 5.22 mm vs 16.74 ± 4.6 mm (P = 0.224), stone diameter was 10.91 ± 3.53 mm vs 11.07 ± 4.12 mm (P = 0.749), and stone HU was 933.33 ± 406.27 vs 942.92 ± 351.19 (P = 0.845) (Tables 5, 6 and 7, Figure 1).

Table 5 Comparison of stone length between group A and B, n (%).
Stone length (mm)
Group A (n = 120)
Group B (n = 120)
Total
P value
mean ± SD15.97 ± 5.2216.74 ± 4.616.35 ± 4.930.224
Median (25th-75th percentile)17 (12-19)17 (14-19.25)17 (13-19)0.224
Range5-286-315-310.224
Table 6 Comparison of stone diameter between group A and B, n (%).
Stone diameter (mm)
Group A (n = 120)
Group B (n = 120)
Total
P value
mean ± SD10.91 ± 3.5311.07 ± 4.1210.99 ± 3.830.749
Median (25th-75th percentile)10 (8-13)11 (8-14)10 (8-14)0.749
Range5-195-205-200.749
Table 7 Comparison of stone Hounsfield units between group A and B.
Stone HU
Group A (n = 120)
Group B (n = 120)
Total
P value
mean ± SD933.33 ± 406.27942.92 ± 351.19938.12 ± 378.960.845
Median (25th-75th percentile)950 (550-1350)900 (600-1200)925 (600-1250)0.845
Range300-1600400-1550300-16000.845

Proportion of patients with stone length: ≤ 5 mm, 5.1-10 mm, 10.1-15 mm, > 20 mm was higher in group A as compared to group B (≤ 5 mm: 1.67% vs 0% respectively, 5.1-10 mm: 15% vs 9.17% respectively, 10.1-15 mm: 29.17% vs 24.17% respectively, > 20 mm: 19.17% vs 13.33% respectively). Proportion of patients with stone length: 15.1-20 mm was lower in group A as compared to group B. (15.1-20 mm: 35% vs 53.33% respectively) (P value = 0.054) (Table 8).

Table 8 Comparison of stone length between group A and B, n (%).
Stone length (mm)
Group A (n = 120)
Group B (n = 120)
Total
P value
≤ 5 mm2 (1.67)0 (0)2 (0.83)0.054
5.1-10 mm18 (15)11 (9.17)29 (12.08)0.054
10.1-15 mm35 (29.17)29 (24.17)64 (26.67)0.054
15.1-20 mm42 (35)64 (53.33)106 (44.17)0.054
> 20 mm23 (19.17)16 (13.33)39 (16.25)0.054
mean ± SD15.97 ± 5.2216.74 ± 4.616.35 ± 4.930.224
Median (25th-75th percentile)17 (12-19)17 (14-19.25)17 (13-19)0.224
Range5-286-315-310.224

Distribution of stone diameter was comparable between group A and B (P value = 0.225). ≤ 5 mm, 15-20 mm was higher in group B as compared to group A (≤ 5 mm: 4.17% vs 6.67%, 15.1-20 mm: 10.83% vs 19.17%). 5.1-10 mm, 10.1-15 mm was higher in group A as compared to group B (5.1-10 mm: 48.33% vs 41.67% respectively, 10.1-15 mm: 36.67% vs 32.50%) (Table 9).

Table 9 Comparison of stone diameter between group A and B, n (%).
Stone diameter (mm)
Group A (n = 120)
Group B (n = 120)
Total
P value
≤ 5 mm5 (4.17)8 (6.67)13 (5.42)0.225
5.1-10 mm58 (48.33)50 (41.67)108 (45)0.225
10.1-15 mm44 (36.67)39 (32.50)83 (34.58)0.225
15.1-20 mm13 (10.83)23 (19.17)36 (15)0.225
mean ± SD10.91 ± 3.5311.07 ± 4.1210.99 ± 3.830.749
Median (25th-75th percentile)10 (8-13)11 (8-14)10 (8-14)0.749
Range5-195-205-200.749

Distribution of stone HU was comparable between group A and B (≤ 500: 24.17% vs 14.17% respectively, 501-1000: 31.67% vs 44.17% respectively, 1001-1500: 40% vs 35.83% respectively, 1501-2000: 4.17% vs 5.83% respectively) (P value = 0.102) (Table 10).

Table 10 Comparison of stone Hounsfield units between group A and B, n (%).
Stone HU
Group A (n = 120)
Group B (n = 120)
Total
P value
≤ 50029 (24.17)17 (14.17)46 (19.17)0.102
501-100038 (31.67)53 (44.17)91 (37.92)0.102
1001-150048 (40)43 (35.83)91 (37.92)0.102
1501-20005 (4.17)7 (5.83)12 (5)0.102
mean ± SD933.33 ± 406.27942.92 ± 351.19938.12 ± 378.960.845
Median (25th-75th percentile)950 (550-1350)900 (600-1200)925 (600-1250)0.845
Range300-1600400-1550300-16000.845

A total of 240 patients were randomized into group A and group B. In group B, 114 patients achieved stone clearance, while intervention was unsuccessful in 6 patients due to technical failure. In group A, stone clearance was achieved in 28 patients after 1 session and in 67 patients after 2 sessions. Group A had a significantly lower proportion of patients with stone clearance compared to group B at all time points: 1 week (23.33% vs 95%), 8 weeks (55.83% vs 95%), and 3 months (55.83% vs 95%) (P < 0.0001 for all) (Table 11, Figure 2).

Table 11 Comparison of stone clearance between group A and B, n (%).
Stone clearance
Group A (n = 120)
Group B (n = 120)
Total
P value
At 1 week28 (23.33)114 (95)142 (59.17)< 0.0001
At 8 weeks67 (55.83)114 (95)181 (75.42)< 0.0001
At 3 months67 (55.83)114 (95)181 (75.42)< 0.0001

Stone clearance was significantly lower in group A compared to group B overall. However, a subgroup analysis based on stone length revealed that the distribution of stone clearance in stone length of ≤ 5 mm, 5.1-10 mm, > 20 mm was comparable between group A and B [≤ 5 mm: 50% vs 0% respectively, 5.1-10 mm: 61.11% vs 90.91% respectively (P = 0.11), > 20 mm: 69.57% vs 93.75% respectively (P = 0.109)]. Proportion of patients with stone clearance in 10.1-15 mm and 15.1-20 mm was significantly lower in group A compared to groups B (10.1-15 mm: 51.43% vs 96.55% respectively (P < 0.0001), 15.1-20 mm: 50% vs 95.31% respectively (P < 0.0001) (Table 12).

Table 12 Comparison of stone clearance in different stone length between group A and B, n (%).
Stone clearance in different stone length
Group A
Group B
Total
P value
≤ 5 mm1 (50)0 (0)1 (50)-
5.1-10 mm11 (61.11)10 (90.91)21 (72.41)0.11
10.1-15 mm18 (51.43)28 (96.55)46 (71.88)< 0.0001
15.1-20 mm21 (50)61 (95.31)82 (77.36)< 0.0001
> 20 mm16 (69.57)15 (93.75)31 (79.49)0.109

Proportion of patients with stone clearance in different stone diameter: ≤ 5 mm, 5.1-10 mm, 10.1-15 mm was significantly lower in group A as compared to group B: ≤ 5 mm: 20% vs 87.50% respectively (P = 0.032), 5.1-10 mm: 53.45% vs 98% respectively (P < 0.0001), 10.1-15 mm: 54.55% vs 94.87% respectively (P < 0.0001).

Distribution of stone clearance in stone diameter of 15-20 mm was comparable between group A and B (15.1-20 mm: 84.62% vs 91.30% respectively (P value = 0.609) (Table 13).

Table 13 Comparison of stone clearance in different stone diameter between group A and B, n (%).
Stone clearance in different stone diameter
Group A
Group B
Total
P value
≤ 5 mm1 (20)7 (87.50)8 (61.54)0.032
5.1-10 mm31 (53.45)49 (98)80 (74.07)< 0.0001
10.1-15 mm24 (54.55)37 (94.87)61 (73.49)< 0.0001
15.1-20 mm11 (84.62)21 (91.30)32 (88.89)0.609

Proportion of patients with stone clearance in different stone HU: ≤ 500, 501-1000, 1001-1500 was significantly lower in group A as compared to group B: ≤ 500: 55.17% vs 94.12% respectively (P = 0.007), 501-1000: 63.16% vs 96.23% respectively (P < 0.0001), 1001-1500: 47.92% vs 93.02% respectively (P < 0.0001)). The distribution of stone clearance for stones with HU in the range of 1501-2000 was lower in group A compared to group B (80% vs 100%, respectively), but this difference was not statistically significant (P = 0.417) (Table 14).

Table 14 Comparison of stone clearance in different stone Hounsfield units between group A and B, n (%).
Stone clearance in different stone HU
Group A
Group B
Total
P value
≤ 50016 (55.17)16 (94.12)32 (69.57)0.007
501-100024 (63.16)51 (96.23)75 (82.42)< 0.0001
1001-150023 (47.92)40 (93.02)63 (69.23)< 0.0001
1501-20004 (80)7 (100)11 (91.67)0.417

Compared to group B, group A had significantly higher proportion of patients with no complications (43.33% vs 25%) and significantly lower proportions with grade 1 complications (53.33% vs 66.67%) and grade 2 complications (3.33% vs 8.33%) (P value = 0.006) (Table 15, Figure 2).

Table 15 Comparison of complications between group A and B, n (%).
Complications
Group A (n = 120)
Group B (n = 120)
Total
P value
No complications52 (43.33)30 (25)82 (34.17)0.006
Grade 164 (53.33)80 (66.67)144 (60)0.006
Grade 24 (3.33)10 (8.33)14 (5.83)0.006
Total120 (100)120 (100)240 (100)0.006

Compared to group B, group A had significantly higher proportion of patients with no post-operative complications (43.33% vs 25%), hematuria (38.33% vs 20.83%), pain (15% vs 0%) and significantly lower proportion with dysuria (0% vs 22.50%), fever (3.33% vs 8.33%), stent-related pain (0% vs 23.33%) (P value < 0.0001) (Figure 3).

Figure 3
Figure 3 Comparison of post-operative complications, analgesics. A: Comparison of post-operative complications between group A and B; B: Comparison of analgesics between group A and B.

In group A, Fluoroscopy was the predominant focusing modality, used in 85.83% (103 cases), while ultrasonography was employed in 14.17% (17 cases). Technical difficulties were encountered in 10 patients (8.33%), primarily due to an inability to focus the stone using either fluoroscopy or ultrasonography.

A significant proportion of patients in group A required two sessions (76.67%, 92 cases) compared to those cleared in one session (23.33%, 28 cases). The mean number of sessions in group A was 1.77 ± 0.42, which was significantly higher than group B (P < 0.0001). Group A had a stone clearance rate of 55.83%, with 23.33% cleared in one session and 32.50% cleared in two sessions. However, 44.17% of patients in group A did not achieve stone clearance, which was significantly higher compared to group B (P < 0.0001).

The mean cumulative energy utilized was 29.75 ± 6 kJ, with a median of 30 kJ (interquartile range: 24.1-35.9 kJ), and the total shocks delivered averaged 1296.11 ± 189.65, with a median of 1278 shocks (interquartile range: 1157-1366.25). The range for energy was 20.4-39.6 kJ, and the total shocks ranged from 998-1885.

The majority of patients (80%, 96 cases) were treated in the supine position, with 16.67% (20 cases) in modified supine and 3.33% (4 cases) in the prone (contralateral) position. Most procedures (85.83%, 103 cases) used an oblique therapy head orientation, with the remaining 14.17% (17 cases) using a vertical therapy head.

The ESWL suite time for group A had a mean ± SD of 28.57 ± 5.19 minutes and a median of 28 minutes (interquartile range: 25-30.25 minutes). The time range for group A was 20-45 minutes.

The ESWL procedure was generally effective for a majority of cases requiring two sessions, with fluoroscopy as the dominant focusing modality and the supine position being the most commonly used. Despite this, a considerable proportion of patients (44.17%) experienced incomplete stone clearance. The detailed distribution of sessions and clearance rates is presented in Tables 16 and 17.

Table 16 Comparison of number of sessions between group A and B, n (%).
Number of sessions
Group A (n = 120)
Group B (n = 120)
Total
P value
128 (23.33)120 (100)148 (61.67)< 0.0001
292 (76.67)0 (0)92 (38.33)< 0.0001
mean ± SD1.77 ± 0.421 ± 01.38 ± 0.49< 0.0001
Median (25th-75th percentile)2 (2-2)1 (1-1)1 (1-2)< 0.0001
Range1-21-11-2< 0.0001
Table 17 Comparison of stone clearance rate between group A and B, n (%).
Stone clearance rate
Group A (n = 120)
Group B (n = 120)
Total
P value
Stone not cleared53 (44.17)6 (5)59 (24.58)< 0.0001
Stone clearance in 1 session28 (23.33)114 (95)142 (59.17)< 0.0001
Stone clearance in 2 sessions39 (32.50)0 (0)39 (16.25)< 0.0001
Total120 (100)120 (100)240 (100)< 0.0001

In group B (URSL), all patients (100%, 120 out of 120) had a double J stent placed intraoperatively. Technical failures were encountered in 6 patients (5%), which included narrow vesico-ureteric junction in 3 patients (2.5%), mucosal flap obstruction in 2 patients (1.67%), and bleeding in 1 patient (0.83%). In these cases, DJ stents were placed, and the procedure was abandoned.

Technical difficulties were noted in 5 patients (4.17%), which required specific intraoperative interventions. Among these, 2 patients (1.67%) required the insertion of a second guidewire and subsequent railroading of the ureteroscope, while 3 patients (2.5%) required balloon dilatation to facilitate ureteroscope entry.

The mean intra-operative time in group B was significantly higher compared to group A, with a mean ± SD of 53.67 ± 13.09 minutes and a median of 50 minutes (interquartile range: 40-60 minutes). The range of intra-operative time for group B was 30-120 minutes.

The hospital stay included 1 day preoperatively, 1 day for the procedure, and the postoperative stay. ESWL was conducted as an outpatient procedure, and patients were provided with detailed treatment advice following the procedure. The mean duration of hospital stay among patients in group B was 3.2 ± 0.4 days, with a median of 3 days (interquartile range: 3.3 days) (Table 18).

Table 18 Descriptive statistics of duration of hospital stay (group B).
Variable
mean ± SD
Median (25th-75th percentile)
Range
Duration of hospital stay (days)3.2 ± 0.43 (3-3)3-5

The VAS scores and associated analgesic use were analyzed to compare pain management between group A (ESWL) and group B (URSL) at key time points: Pre-procedure, post-procedure, at 1 week, and at 8 weeks. Both groups showed comparable pain medication use pre-procedure, post-procedure, and at 1 week, with no significant differences in non steroidal anti-inflammatory drugs, opioids, or paracetamol usage. By 8 weeks, a higher proportion of patients in group B required no medication compared to those in group A, although this difference was not statistically significant. Detailed data on medication distribution is available in Table 19.

Table 19 Comparison of analgesics between group A and B, n (%).
Analgesics
Group A (n = 120)
Group B (n = 120)
Total
P value
Pre-procedurePre-procedurePre-procedurePre-procedurePre-procedure
NSAID27 (22.50)26 (21.67)53 (22.08)0.988
Opioid11 (9.17)11 (9.17)22 (9.17)0.988
PCM82 (68.33)83 (69.17)165 (68.75)0.988
mean ± SD7.08 ± 1.687.08 ± 1.687.08 ± 1.671
Median (25th-75th percentile)7 (6-8)7 (6-8)7 (6-8)1
Range5-105-105-101
Post-procedurePost-procedurePost-procedurePost-procedurePost-procedure
NSAID10 (8.33)16 (13.33)26 (10.83)0.415
Opiod4 (3.33)5 (4.17)9 (3.75)0.415
PCM106 (88.33)99 (82.50)205 (85.42)0.415
mean ± SD4.94 ± 1.364.94 ± 1.384.94 ± 1.361
Median (25th-75th percentile)5 (4-6)5 (4-6)5 (4-6)1
Range2-82-82-81
At 1 weekAt 1 weekAt 1 weekAt 1 weekAt 1 week
No medication39 (32.50)44 (36.67)83 (34.58)0.335
NSAID0 (0)2 (1.67)2 (0.83)0.335
PCM81 (67.50)74 (61.67)155 (64.58)0.335
mean ± SD3.42 ± 0.924.42 ± 1.333.92 ± 1.25< 0.0001
Median (25th-75th percentile)3 (3-3)4 (3-5)3 (3-4)< 0.0001
Range3-73-93-9< 0.0001
At 8 weeksAt 8 weeksAt 8 weeksAt 8 weeksAt 8 weeks
No medication85 (70.83)96 (80)181 (75.42)0.133
NSAID1 (0.83)0 (0)1 (0.42)0.133
PCM34 (28.33)24 (20)58 (24.17)0.133
mean ± SD2.94 ± 0.953.42 ± 0.993.18 ± 10.0001
Median (25th-75th percentile)3 (2-4)3 (3-4)3 (3-4)0.0001
Range1-61-61-60.0001

VAS scores revealed similar pain levels pre-procedure (mean score of 7.08 in both groups) and immediately post-procedure (mean score of 4.94 in both groups). However, group A demonstrated significantly better pain relief at later follow-up points. At 1 week, the mean VAS score in group A was significantly lower (3.42) compared to group B (4.42). This trend persisted at 8 weeks, with group A reporting a mean score of 2.94 vs 3.42 in group B. These differences were statistically significant, indicating that group A experienced more rapid and sustained pain relief after the procedure.

The EQ5D5 L scale showed no significant difference between group A (ESWL) and group B (URSL) at 8 weeks [median: 1 (0.949-1) in both groups, P = 0.674] or at 3 months [median: 1 (1-1) in both groups, P = 1]. However, a significant difference was observed immediately post-procedure, with group A exhibiting a slightly lower EQ5D5 L score [median: 0.87 (0.858-0.932)] compared to group B [median: 0.9 (0.874-0.949), P = 0.042]. These results indicate that while early post-procedure quality of life (QoL) was marginally better in group B, both groups achieved comparable outcomes by 8 weeks and 3 months (Table 20 and Figure 4).

Figure 4
Figure 4 Comparison of Visual Analog Scale, trend of EQ5D5 L scale. A: Comparison of Visual Analog Scale between group A and B; B: Comparison of trend of EQ5D5 L scale at different time intervals between group A and B. VAS: Visual Analog Scale.
Table 20 Comparison of EQ5D5 L scale between group A and B.
EQ5D5 L scale
Group A (n = 120)
Group B (n = 120)
Total
P value
Post-procedurePost-procedurePost-procedurePost-procedurePost-procedure
mean ± SD0.89 ± 0.040.9 ± 0.040.9 ± 0.040.042
Median (25th-75th percentile)0.87 (0.858-0.932)0.9 (0.874-0.949)0.88 (0.874-0.949)0.042
Range0.81-0.950.81-0.950.81-0.950.042
At 8 weeksAt 8 weeksAt 8 weeksAt 8 weeksAt 8 weeks
mean ± SD0.99 ± 0.020.98 ± 0.020.98 ± 0.020.674
Median (25th-75th percentile)1 (0.949-1)1 (0.949-1)1 (0.949-1)0.674
Range0.95-10.95-10.95-10.674
At 3 monthsAt 3 monthsAt 3 monthsAt 3 monthsAt 3 months
mean ± SD1 ± 01 ± 01 ± 01
Median (25th-75th percentile)1 (1-1)1 (1-1)1 (1-1)1
Range1-11-11-11

Group A (ESWL) showed significantly fewer mean working days lost compared to group B (URSL) (5.08 ± 1.08 days vs 8 ± 0.64 days, P < 0.0001). The median days lost were 5 days in group A and 8 days in group B. This highlights the shorter recovery period associated with ESWL (Figure 5).

Figure 5
Figure 5 Comparison of working days lost , patient satisfaction, acceptability. A: Comparison of working days lost between group A and B; B: Comparison of cost between group A and B; C: Comparison of patient satisfaction between group A and B; D: Comparison of acceptability between group A and B.

The cost of treatment was significantly lower in group A, with a mean cost of 4386.67 ± 1827.76 compared to 5049.17 ± 2067.26 in group B (P = 0.009). The median costs were 4575 in group A and 5150 in group B, indicating a financial advantage for ESWL (Table 21, Figure 5).

Table 21 Comparison of cost between group A and B.
Cost
Group A (n = 120)
Group B(n = 120)
Total
P value
mean ± SD4386.67 ± 1827.765049.17 ± 2067.264717.92 ± 1975.190.009
Median (25th-75th percentile)4575 (3237.5-5650)5150 (3087.5-7012.5)4775 (3200-6250)0.009
Range750-78501500-8650750-86500.009

Patient satisfaction was significantly higher in group A, with a mean score of 4.07 ± 0.66 compared to 3.78 ± 0.71 in group B (P = 0.002). Both groups had a median satisfaction score of 4, indicating generally positive outcomes for both treatments (Figure 5).

No significant difference was observed in acceptability between the two groups. Mean acceptability scores were nearly identical: 4.02 ± 0.59 in group A and 4.03 ± 0.66 in group B (P = 0.837). The median score of 4 across both groups suggests high acceptability for both interventions (Figure 5).

DISCUSSION

In this study, the mean age of patients was comparable between group A (35.89 ± 10.09 years) and group B (36.08 ± 13.45 years) (P = 0.901), with both groups having a higher proportion of patients aged 31-40 years, aligning with existing literature indicating peak urolithiasis incidence between 30 years and 60 years[27-30]. Gender distribution was also comparable, with a male predominance in both groups (64.17% in group A, 70% in group B; P = 0.336), consistent with global studies by Faridi and Singh[29] and Tseng et al[30]. Baseline characteristics, including comorbidities and laboratory parameters, were well matched.

Stone characteristics including length, diameter, and density (HU) were comparable across groups (length: 15.97 ± 5.22 mm vs 16.74 ± 4.6 mm, P = 0.224; diameter: 10.91 ± 3.53 mm vs 11.07 ± 4.12 mm, P = 0.749; HU: 933.33 ± 406.27 vs 942.92 ± 351.19, P = 0.845). Distribution of stone sizes and densities was not significantly different (P > 0.05).

Group B (URSL) consistently achieved significantly higher SFR than group A (ESWL) across all time intervals: At 1 week (95% vs 23.33%, P < 0.0001), at 8 weeks (95% vs 55.83%, P < 0.0001), and at 3 months (95% vs 55.83%, P < 0.0001). For stones 10.1-15 mm and 15.1-20 mm, SFR was significantly better in group B (96.55% vs 51.43%, P < 0.0001 and 95.31% vs 50%, P < 0.0001, respectively). Similarly, for stone diameters ≤ 5 mm, 5.1-10 mm, and 10.1-15 mm, group B showed superior clearance (87.50% vs 20%, P = 0.032; 98% vs 53.45%, P < 0.0001; 94.87% vs 54.55%, P < 0.0001). For stones 15.1-20 mm, clearance was comparable (91.30% vs 84.62%, P = 0.609).

These findings corroborate studies by Liu et al[31], Wu et al[32], Verze et al[33], El-Abd et al[34], and systematic reviews by Sokouti et al[35] and Drake et al[36], all demonstrating superior SFR with URSL. Drake et al[36] and Jung et al[23] further confirmed URSL’s consistent advantage, particularly for stones > 10 mm. ESWL success of 59% for stones ≥ 15 mm after three sessions, compared to 86.4% for ureteroscopy (URS) (P < 0.0001)[37,38].

This study supports the Europeam Association of Urology guideline recommendations for size-based treatment. URSL is superior for medium to large stones (> 10 mm), while ESWL remains suitable for smaller stones. Stone density also influenced outcomes; ESWL had significantly lower clearance for stones with higher HU, emphasizing the role of HU in treatment selection. Incorporating stone size and density into treatment planning enhances outcomes, patient satisfaction, and healthcare efficiency.

For stones with HU ≤ 500, group A (ESWL) showed a significantly lower clearance rate than group B (URSL) (55.17% vs 94.12%, P = 0.007). Similar disparities were observed in the 501-1000 HU group (63.16% vs 96.23%, P < 0.0001) and 1001-1500 HU group (47.92% vs 93.02%, P < 0.0001). In stones > 1500 HU, rates were comparable (80% vs 100%, P = 0.417), likely due to smaller stone sizes in group A (mean length 11.2 mm; diameter 8.4 mm).

These findings align with prior studies indicating HU as a key determinant in ESWL outcomes. Hameed et al[39] and Foda et al[40] observed lower fragmentation success with HU > 1000 or > 1350. Gupta et al[41] noted that densities > 750 HU often required ≥ 3 ESWL sessions, with only 65% clearance, while ≤ 750 HU stones achieved 88% clearance. Conversely, URSL success appears less HU-dependent. Kim et al[42] and Abdelbary et al[43] demonstrated high URSL efficacy (SFR 96.2%) regardless of HU ≤ 1000.

Gücük and Uyetürk[44] emphasized HU-based treatment stratification. Ouzaid et al[45] found that stones with HU < 970 had ESWL success rates up to 96%. Therefore, URSL is generally preferred for high-HU stones due to greater efficacy and less dependence on stone density.

Overall, ESWL had a lower clearance rate (55.83%) vs URSL (95%) with fewer sessions (mean 1.77 ± 0.42 vs primarily single-session, P < 0.0001). These results corroborate Wu et al[32] and El-Abd et al[34] on URSL’s superior performance for complex cases. ESWL predominantly used fluoroscopy (85.83%) and supine positioning (80%), with focusing challenges in 8.33% - findings supported by Drake et al[36]. In contrast, URSL consistently achieved success with intraoperative DJ stents; failures (5%) were manageable with interventions like guidewire railroading or balloon dilation[34].

Recovery and burden differences were notable. ESWL patients had fewer workdays lost (5.08 ± 1.08 days vs 8 ± 0.64 days, P < 0.0001) and often avoided hospital admission, unlike URSL (mean stay: 3.2 ± 0.4 days; operative time: 53.67 ± 13.09 minutes). Pearle et al[46] emphasized ESWL’s low occupational disruption. Despite this, URSL’s single-session efficacy minimizes repeat procedures.

Complication profiles differed

ESWL had fewer overall complications (43.33% vs 25%, P = 0.006), but higher rates of hematuria (38.33% vs 20.83%, P < 0.0001) and pain (15% vs 0%, P < 0.0001) from stone passage trauma[43,47]. URSL had more grade 1 (66.67%) and grade 2 (8.33%) complications, often due to stents - dysuria (22.5% vs 0%, P < 0.0001) and stent-related pain (23.33% vs 0%, P < 0.0001). Fever was more common post-URS (8.33% vs 3.33%, P < 0.0001), reflecting its invasive nature.

The Clinical Research Office of the Endourological Society URS Global study reported similar URS risks (fever 1.72%, urinary tract infection 0.95%, sepsis 0.30%, stent misplacement 0.10%)[48]. Xu et al[49] noted ESWL reduced overall complications by 37%. Verze et al[33] reported lower complication rates for ESWL (15.32%) than URS (19.11%). Specific ESWL complications include steinstrasse (2%-7.7%)[36,50], while URSL risks include ureteral injuries (0%-6.6%)[36]. While ESWL-related hematuria is usually self-limiting, URSL complications often require further management.

This study emphasizes the importance of individualized treatment decisions in ureteral stone management. ESWL, a less invasive option, is optimal for smaller stones (< 1 cm), offering lower systemic complications but associated with transient hematuria and pain. URS is better suited for larger or impacted stones (> 1 cm), providing superior stone clearance but with higher procedural and stent-related complications.

Pain and analgesic use

VAS scores were similar pre- and immediately post-procedure in both groups (7.08 ± 1.68; 4.94 ± 1.36/1.38; P = 1). However, ESWL (group A) showed significantly lower scores at 1 week and 8 weeks (3.42 vs 4.42 and 2.94 vs 3.42; P < 0.0001, 0.0001). This reflects reduced stent-related discomfort. Analgesic use mirrored these trends (Hamamoto et al[51], Aboumarzouk et al[22], Pearle et al[46], Drake et al[36]).

Cost analysis

Group A (ESWL) had lower mean costs (Rs 4386.67 vs Rs 5049.17; P = 0.009). ESWL is cost-effective for stones < 1 cm, especially in outpatient settings (Wu et al[32], Salem et al[52], Parker et al[53], Shemesh et al[54], Kilonzo et al[55]). URS’s superior SFR offsets its higher procedural costs in complex cases (Koo et al[56], Lotan et al[57], Cone et al[58], Geraghty et al[25], Constanti et al[24]).

QoL

Immediate post-op EQ-5D-5 L scores were slightly lower in ESWL (0.87 vs 0.9; P = 0.042), improving by 8 weeks. Differences reflect procedure invasiveness and stent-related symptoms (Hamamoto et al[51], Dasgupta et al[59], Rabah et al[60], Bensalah et al[61]). URS may offer better early QoL but ESWL provides a comparable long-term profile. Disease-specific tools are needed for refined assessment.

Work absence and recovery

Mean days lost were significantly fewer in ESWL (5.08 vs 8; P < 0.0001), reinforcing its outpatient advantage and reduced convalescence (Aboumarzouk et al[22], Pearle et al[46]).

Patient satisfaction

Satisfaction was higher in ESWL (4.07 vs 3.78; P = 0.002), though median scores were similar. Acceptability was high in both groups (> 80%), aligning with previous studies (Dasguptaet al[59], Pearle et al[46], Xu et al[49], Lee et al[62]).

In conclusion, both ESWL and URS are effective, with distinct advantages depending on stone characteristics. While URS ensures higher stone-free rates, ESWL provides cost-effectiveness, better QoL recovery, and fewer working days lost, especially in small stone cases.

CONCLUSION

This randomized controlled trial comparing ESWL and ureteroscopy with laser lithotripsy (URSL) for lower ureteric stones highlights key clinical and economic outcomes. URSL demonstrated significantly higher SFRs, especially for stones > 10 mm, supporting its efficacy as a definitive treatment. Although patients undergoing URSL experienced a temporary decline in QoL due to its invasive nature, QoL outcomes equalized with ESWL by 8 weeks. ESWL, favored for its non-invasive approach and lower upfront costs, often required multiple sessions and showed lower SFRs. URSL, while costlier initially, was more cost-effective for larger stones due to single-session success. Patient satisfaction was high for both modalities, with ESWL preferred for comfort and URSL for effectiveness. Complication rates were lower for ESWL short-term, but URSL minimized long-term risks by achieving complete stone clearance. The study noted that stone size and density were important predictors of success, though differences in outcomes based on density were not statistically significant. Limitations included a lack of full economic analysis and the absence of disease-specific QoL metrics. Both treatments are viable, with URSL offering superior outcomes for larger or more complex stones.

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Footnotes

Peer review: Externally peer reviewed.

Peer-review model: Single blind

Specialty type: Critical care medicine

Country of origin: India

Peer-review report’s classification

Scientific quality: Grade B

Novelty: Grade C

Creativity or innovation: Grade C

Scientific significance: Grade C

P-Reviewer: He ZH, PhD, Chief Physician, China S-Editor: Bai Y L-Editor: A P-Editor: Yu HG

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