Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

NCT06144372 | Completed

• 1 other identifier: ESWL_ECEH
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urolithiasis

Keywords

Extracorporeal shockwave lithotripsy; Urolithiasis; Radiation Exposure

Outcome Measures

Primary Outcomes (32)

• 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

  1. Not satisfied at all. 2. Very low satisfaction. 3. Moderate satisfaction. 4. High satisfaction. 5. Very high or maximum satisfaction.

  2 weeks

• Stone-free rates (%)

  ESWL

  2 weeks

Study Arms (2)

Electroconductive Type

OTHER

Sonolith i-move® shockwave lithotripter (EDAP, Lyon, France)

Device: Electroconductive and Electrohydraulic types

Electrohydraulic Type

OTHER

Rifle lithotripter (HNT Medical, Seoul, Korea)

Device: Electroconductive and Electrohydraulic types

Interventions

Electroconductive and Electrohydraulic types DEVICE

The patients were randomly assigned to two types of lithotripter.

Electroconductive Type; Electrohydraulic Type

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related 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.

  PMID: 35801399 BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 22, 2023
• Study Start: March 31, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)