Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06144372
• Other study ID #: ESWL_ECEH
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Calculi
• Urolithiasis

Intervention

Device:
• Electroconductive and Electrohydraulic types
The patients were randomly assigned to two types of lithotripter.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	age	patient's records	2 weeks
Primary	Gender	patient's records	2 weeks
Primary	height	meters	2 weeks
Primary	weight	kilograms	2 weeks
Primary	smoking	patient's records	2 weeks
Primary	drinking	patient's records	2 weeks
Primary	Diabetes mellitus	patient's records	2 weeks
Primary	Hypertension	patient's records	2 weeks
Primary	Preoperative Double J stent	patient's records	2 weeks
Primary	creatinine	patient's records	2 weeks
Primary	Glomerular Filtration Rate	patient's records	2 weeks
Primary	hemoglobin	patient's records	2 weeks
Primary	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
Primary	Analgesic	patient's records	2 weeks
Primary	stone size	patient's records	2 weeks
Primary	Stone laterality	patient's records	2 weeks
Primary	Stone location	patient's records	2 weeks
Primary	Stone volume	patient's records	2 weeks
Primary	Stone shape	patient's records	2 weeks
Primary	Stone to skin distance	patient's records	2 weeks
Primary	Hounsfield unit	patient's records	2 weeks
Primary	Urine color	patient's records	2 weeks
Primary	Urine Turbidity	patient's records	2 weeks
Primary	Urine Specific Gravity	patient's records	2 weeks
Primary	Urine pH	patient's records	2 weeks
Primary	Intensity	ESWL	2 weeks
Primary	Used power	ESWL	2 weeks
Primary	Shock	ESWL	2 weeks
Primary	Speed	ESWL	2 weeks
Primary	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
Primary	Satisfaction score	Not satisfied at all.; Very low satisfaction.; Moderate satisfaction.; High satisfaction.; Very high or maximum satisfaction.	2 weeks
Primary	Stone-free rates (%)	ESWL	2 weeks