Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

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

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Device: Electroconductive and Electrohydraulic types

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Motolova M, Kral M. Effect of targeting and generator type on efficacy of extracorporeal shock wave lithotripsy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 Dec;166(4):434-440. doi: 10.5507/bp.2022.029. Epub 2022 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Urolithiasis; Radiation Exposure; Extracorporeal shockwave lithotripsy
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: ESWL_ECEH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used during the current study are available from the corresponding author on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No