Design of Working Groups and Inclusion Criteria
The study that was conducted as a single-center analytical cross-sectional retrospective study, examined approximately 450 patients who came to the Sancaktepe Education and Research Hospital urology clinic with suspicion of urolithiasis between June 2023 and June 2024. Patients with ureteral stones detected by Non-Contrast Computed Tomography (NCCT) and complete clinical data were selected for the study. Of these patients, 151 patients who had an indication for ESWL treatment due to ureteral stones were included in the study. The density of the stones was measured in HU. Demographic characteristics (age, gender, BMI), symptoms [renal colic, oliguria/anuria, nausea and vomiting, dysuria, difficulty urinating, pollakiuria, fever and chills, and costovertebral angle (CVA) tenderness (CVAT)] and urine examination findings [hematuria, urine color, urine odor, density, pH, erythrocytes, leukocytes, casts, protein, calcium oxalate monohydrate (COM) or calcium oxalate dihydrate (COD) crystals, Struvite crystals, amorphous urate crystals, amorphous phosphate crystals] were recorded. In addition, patients were questioned about physical inactivity, oral contraceptives (OCs) use, and comorbidity status (hypertension, diabetes, metabolic syndrome, obesity, chronic kidney disease, cardiovascular diseases, gout, hyperlipidemia, inflammatory bowel disease, osteoporosis, malignancy, thyroid disease, uric acid metabolism disorder, and hypercoagulability, etc.). Those included in the study groups were divided into 2 groups according to the success of ESWL treatment, 116 of them were successful in treatment, while 35 patients were unsuccessful.
Exclusion Criteria
Those who were younger than 18 or older than 70 years, those with urinary tract infection, those who were pregnant, those who had undergone surgery before treatment, those with chronic renal failure, those with coagulopathy, those with stones >20 mm or <5 mm [In the treatment planning of patients in our study, the recommendations of the EAU (European Association of Urology) guidelines were considered. URS was regarded as the first-line treatment option for ureteral stones larger than 10 mm. However, in accordance with the practice protocol of our center, patients were evaluated for ESWL feasibility rather than undergoing URS. Patients included in this study had not undergone URS previously and were directly assessed for ESWL treatment.], those with anatomical anomalies in the kidney, those with serious cardiac disease, patients with a single kidney, those with a stent inserted in the urinary system, those who were noncompliant with treatment or did not come for follow-up were excluded from the study.
Stone Density (HU) Measurement
Stone density of each patient was measured in HU on NCCT images (Canon, Aquilion Lightning 16, Japan). Images were obtained using the same standards [2 mm slice thickness, 120 kVp, 200 mA]. The site of the ureteral calculi was identified by the radiologist and the density of the stone was measured. Using radiology software for measurement, HU values were obtained from at least 3 different points from the center of the stone and the mean density of the stone was determined by calculating the average of these values.
ESWL Treatment Protocol
Patient Selection: Patients who were diagnosed with ureterolithiasis by NCCT or ultrasound and who were eligible for ESWL according to stone size (5 - 20 mm), localization (stones located in the upper and lower part of the ureter) and HU values were treated with ESWL. The stone density was measured by HU values. Stones below 1000 HU could be easily fragmented by ESWL, while stones with high density above 1000 HU were predicted to be more resistant to treatment.
Preoperative Evaluation: Laboratory tests including complete blood count, coagulation parameters, urinalysis and urine culture were performed before treatment. Patients with active urinary infection were enrolled in ESWL procedure after controlling with antibiotic treatment. During treatment, patients were hospitalized in supine position. To provide pain control during ESWL, 75 mg diclofenac potassium was administered intramuscular half an hour before the procedure.
Modulith SLK inline lithotripter [Storz Medical, Switzerland] was used in ESWL treatment. The treatment was performed by applying a maximum of 4000 shock waves at a frequency of 60-90 shocks/minute in each session. The energy level of the shock waves was initially set between 0.5-1.0 mJ/mm² and gradually increased up to 2.0-3.0 mJ/mm² according to the characteristics of the stone and the patient. Fluoroscopy was used for stone localization and ultrasonography was used for radiolucent stones. If no complications developed after ESWL treatment, the next session was scheduled 7 days later. A total of 3 sessions were performed and treatment response was evaluated at each session.
Post-Treatment Follow-up: After ESWL treatment, patients were followed up clinically to evaluate renal function. NCCT was performed 3 months after treatment to evaluate treatment success. Stone-free or stone fragmentation ≤4 mm on post-treatment imaging was considered as a criterion for treatment success. Post-treatment complications such as hematuria, severe renal pain, urinary infection or stone obstruction were controlled.
Ethical Approval for this study was obtained from the Sancaktepe Training and Research Hospital Clinical Research Ethics Committee (Decision No: 2024/298, dated 24.09.2024, numbered E-46059653-050.99-254458275). All patients participating in the study were informed about the study and their informed consent was obtained.
Statistical Analysis
IBM SPSS Statistic Software program (Version-27, Chicago, USA) was used for processing the data obtained from the study and for statistical evaluation. Kolmogorov Smirnov test was used for normality test of the data. Chi square test was applied for evaluation of categorical data. Student t test and Mann-Whitney test were used for comparison of parametric and non-parametric data of two groups, respectively. Pearson correlation analysis and Spearman correlation analysis were performed for examination of the relationship between parametric and non-parametric data of independent variables, respectively. Binary logistic regression analysis was applied using independent variables consisting of age, lower/upper localization, SSD, stone density and stone size, which are thought to influence ESWL success. Bar chart and box plots graphics were used for presentation of non-parametric data.
Power Analysis of the Study
In order to determine the minimum number of subjects required for this study, a priori power analysis (G-Power version 3.1, Germany) was performed based on the data of a study investigating the factors affecting the outcome of ESWL in the treatment of urinary stones (14). As a result of this analysis, it was calculated that at least 18 experimental subjects (ESWL successful) and 18 independent controls (ESWL unsuccessful) were required for urolithiasis stone density (effect size d = 1.01, α = 0.05, power = 0.90). However, since each group should consist of at least 30 subjects to achieve a stronger prediction and parametric statistical analyses, the number of ESWL successful groups was determined as 116 and the number of ESWL unsuccessful groups as 35.
MATERIALS AND METHODS
Design of Working Groups and Inclusion Criteria
The study that was conducted as a single-center analytical cross-sectional retrospective study, examined approximately 450 patients who came to the Sancaktepe Education and Research Hospital urology clinic with suspicion of urolithiasis between June 2023 and June 2024. Patients with ureteral stones detected by Non-Contrast Computed Tomography (NCCT) and complete clinical data were selected for the study. Of these patients, 151 patients who had an indication for ESWL treatment due to ureteral stones were included in the study. The density of the stones was measured in HU. Demographic characteristics (age, gender, BMI), symptoms [renal colic, oliguria/anuria, nausea and vomiting, dysuria, difficulty urinating, pollakiuria, fever and chills, and costovertebral angle (CVA) tenderness (CVAT)] and urine examination findings [hematuria, urine color, urine odor, density, pH, erythrocytes, leukocytes, casts, protein, calcium oxalate monohydrate (COM) or calcium oxalate dihydrate (COD) crystals, Struvite crystals, amorphous urate crystals, amorphous phosphate crystals] were recorded. In addition, patients were questioned about physical inactivity, oral contraceptives (OCs) use, and comorbidity status (hypertension, diabetes, metabolic syndrome, obesity, chronic kidney disease, cardiovascular diseases, gout, hyperlipidemia, inflammatory bowel disease, osteoporosis, malignancy, thyroid disease, uric acid metabolism disorder, and hypercoagulability, etc.). Those included in the study groups were divided into 2 groups according to the success of ESWL treatment, 116 of them were successful in treatment, while 35 patients were unsuccessful.
Exclusion Criteria
Those who were younger than 18 or older than 70 years, those with urinary tract infection, those who were pregnant, those who had undergone surgery before treatment, those with chronic renal failure, those with coagulopathy, those with stones >20 mm or <5 mm [In the treatment planning of patients in our study, the recommendations of the EAU (European Association of Urology) guidelines were considered. URS was regarded as the first-line treatment option for ureteral stones larger than 10 mm. However, in accordance with the practice protocol of our center, patients were evaluated for ESWL feasibility rather than undergoing URS. Patients included in this study had not undergone URS previously and were directly assessed for ESWL treatment.], those with anatomical anomalies in the kidney, those with serious cardiac disease, patients with a single kidney, those with a stent inserted in the urinary system, those who were noncompliant with treatment or did not come for follow-up were excluded from the study.
Stone Density (HU) Measurement
Stone density of each patient was measured in HU on NCCT images (Canon, Aquilion Lightning 16, Japan). Images were obtained using the same standards [2 mm slice thickness, 120 kVp, 200 mA]. The site of the ureteral calculi was identified by the radiologist and the density of the stone was measured. Using radiology software for measurement, HU values were obtained from at least 3 different points from the center of the stone and the mean density of the stone was determined by calculating the average of these values.
ESWL Treatment Protocol
Patient Selection: Patients who were diagnosed with ureterolithiasis by NCCT or ultrasound and who were eligible for ESWL according to stone size (5 - 20 mm), localization (stones located in the upper and lower part of the ureter) and HU values were treated with ESWL. The stone density was measured by HU values. Stones below 1000 HU could be easily fragmented by ESWL, while stones with high density above 1000 HU were predicted to be more resistant to treatment.
Preoperative Evaluation: Laboratory tests including complete blood count, coagulation parameters, urinalysis and urine culture were performed before treatment. Patients with active urinary infection were enrolled in ESWL procedure after controlling with antibiotic treatment. During treatment, patients were hospitalized in supine position. To provide pain control during ESWL, 75 mg diclofenac potassium was administered intramuscular half an hour before the procedure.
Modulith SLK inline lithotripter [Storz Medical, Switzerland] was used in ESWL treatment. The treatment was performed by applying a maximum of 4000 shock waves at a frequency of 60-90 shocks/minute in each session. The energy level of the shock waves was initially set between 0.5-1.0 mJ/mm² and gradually increased up to 2.0-3.0 mJ/mm² according to the characteristics of the stone and the patient. Fluoroscopy was used for stone localization and ultrasonography was used for radiolucent stones. If no complications developed after ESWL treatment, the next session was scheduled 7 days later. A total of 3 sessions were performed and treatment response was evaluated at each session.
Post-Treatment Follow-up: After ESWL treatment, patients were followed up clinically to evaluate renal function. NCCT was performed 3 months after treatment to evaluate treatment success. Stone-free or stone fragmentation ≤4 mm on post-treatment imaging was considered as a criterion for treatment success. Post-treatment complications such as hematuria, severe renal pain, urinary infection or stone obstruction were controlled.
Ethical Approval for this study was obtained from the Sancaktepe Training and Research Hospital Clinical Research Ethics Committee (Decision No: 2024/298, dated 24.09.2024, numbered E-46059653-050.99-254458275). All patients participating in the study were informed about the study and their informed consent was obtained.
Statistical Analysis
IBM SPSS Statistic Software program (Version-27, Chicago, USA) was used for processing the data obtained from the study and for statistical evaluation. Kolmogorov Smirnov test was used for normality test of the data. Chi square test was applied for evaluation of categorical data. Student t test and Mann-Whitney test were used for comparison of parametric and non-parametric data of two groups, respectively. Pearson correlation analysis and Spearman correlation analysis were performed for examination of the relationship between parametric and non-parametric data of independent variables, respectively. Binary logistic regression analysis was applied using independent variables consisting of age, lower/upper localization, SSD, stone density and stone size, which are thought to influence ESWL success. Bar chart and box plots graphics were used for presentation of non-parametric data.
Power Analysis of the Study
In order to determine the minimum number of subjects required for this study, a priori power analysis (G-Power version 3.1, Germany) was performed based on the data of a study investigating the factors affecting the outcome of ESWL in the treatment of urinary stones (14). As a result of this analysis, it was calculated that at least 18 experimental subjects (ESWL successful) and 18 independent controls (ESWL unsuccessful) were required for urolithiasis stone density (effect size d = 1.01, α = 0.05, power = 0.90). However, since each group should consist of at least 30 subjects to achieve a stronger prediction and parametric statistical analyses, the number of ESWL successful groups was determined as 116 and the number of ESWL unsuccessful groups as 35.