Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.

Official Title
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Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types

Conditions
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Urolithiasis

Intervention / Treatment
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* Device: Electroconductive and Electrohydraulic types


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm. Exclusion Criteria: Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Electroconductive Type<br>Sonolith i-move® shockwave lithotripter (EDAP, Lyon, France) | Device: Electroconductive and Electrohydraulic types<br>* The patients were randomly assigned to two types of lithotripter.<br>|
| Other: Electrohydraulic Type<br>Rifle lithotripter (HNT Medical, Seoul, Korea) | Device: Electroconductive and Electrohydraulic types<br>* The patients were randomly assigned to two types of lithotripter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | patient's records | 2 weeks | 
| Gender | patient's records | 2 weeks | 
| height | meters | 2 weeks | 
| weight | kilograms | 2 weeks | 
| smoking | patient's records | 2 weeks | 
| drinking | patient's records | 2 weeks | 
| Diabetes mellitus | patient's records | 2 weeks | 
| Hypertension | patient's records | 2 weeks | 
| Preoperative Double J stent | patient's records | 2 weeks | 
| creatinine | patient's records | 2 weeks | 
| Glomerular Filtration Rate | patient's records | 2 weeks | 
| hemoglobin | patient's records | 2 weeks | 
| Hydronephrosis grade | Grade 0 : Normal examination with no dilation of the renal pelvis Grade 1 : Mild dilation of the renal pelvis only Grade II : Moderate dilation of the renal pelvis including a few calyces Grade III : Dilation of the renal pelvis with visualization of all the calyces, which are uniformly dilated, and normal renal parenchyma Grade IV : Similar apperance of the renal pelvis and calyces as Grade III, plus thinning of the renal parenchyma | 2 weeks | 
| Analgesic | patient's records | 2 weeks | 
| stone size | patient's records | 2 weeks | 
| Stone laterality | patient's records | 2 weeks | 
| Stone location | patient's records | 2 weeks | 
| Stone volume | patient's records | 2 weeks | 
| Stone shape | patient's records | 2 weeks | 
| Stone to skin distance | patient's records | 2 weeks | 
| Hounsfield unit | patient's records | 2 weeks | 
| Urine color | patient's records | 2 weeks | 
| Urine Turbidity | patient's records | 2 weeks | 
| Urine Specific Gravity | patient's records | 2 weeks | 
| Urine pH | patient's records | 2 weeks | 
| Intensity | ESWL | 2 weeks | 
| Used power | ESWL | 2 weeks | 
| Shock | ESWL | 2 weeks | 
| Speed | ESWL | 2 weeks | 
| Visual analog scale for pain | 0: Represents No sensation or Not at all. 1-3: Indicates a very mild sensation or a low level of the experience, signifying almost no problem. 4-6: Represents a moderate level, suggesting a moderate presence of the experience or issue. 7-9: Reflects a high or severe level, signifying a significant presence or seriousness of the problem. 10: Represents Maximal sensation or Extremely intense and indicates an extreme presence or severity of the experience or issue. | 2 weeks | 
| Satisfaction score | Not satisfied at all. Very low satisfaction. Moderate satisfaction. High satisfaction. Very high or maximum satisfaction. | 2 weeks | 
| Stone-free rates (%) | ESWL | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal shockwave lithotripsy, Urolithiasis, Radiation Exposure