Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- creatinine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Electroconductive Type
Sonolith i-move® shockwave lithotripter (EDAP, Lyon, France)
Intervention: Electroconductive and Electrohydraulic types (Device)
Electrohydraulic Type
Rifle lithotripter (HNT Medical, Seoul, Korea)
Intervention: Electroconductive and Electrohydraulic types (Device)
Outcomes
Primary Outcomes
creatinine
Time Frame: 2 weeks
patient's records
age
Time Frame: 2 weeks
patient's records
Used power
Time Frame: 2 weeks
ESWL
Gender
Time Frame: 2 weeks
patient's records
drinking
Time Frame: 2 weeks
patient's records
height
Time Frame: 2 weeks
meters
Diabetes mellitus
Time Frame: 2 weeks
patient's records
Preoperative Double J stent
Time Frame: 2 weeks
patient's records
Speed
Time Frame: 2 weeks
ESWL
weight
Time Frame: 2 weeks
kilograms
smoking
Time Frame: 2 weeks
patient's records
Hypertension
Time Frame: 2 weeks
patient's records
Glomerular Filtration Rate
Time Frame: 2 weeks
patient's records
hemoglobin
Time Frame: 2 weeks
patient's records
Hounsfield unit
Time Frame: 2 weeks
patient's records
Urine Turbidity
Time Frame: 2 weeks
patient's records
Satisfaction score
Time Frame: 2 weeks
1. Not satisfied at all. 2. Very low satisfaction. 3. Moderate satisfaction. 4. High satisfaction. 5. Very high or maximum satisfaction.
stone size
Time Frame: 2 weeks
patient's records
Stone volume
Time Frame: 2 weeks
patient's records
Stone to skin distance
Time Frame: 2 weeks
patient's records
Urine pH
Time Frame: 2 weeks
patient's records
Intensity
Time Frame: 2 weeks
ESWL
Analgesic
Time Frame: 2 weeks
patient's records
Stone laterality
Time Frame: 2 weeks
patient's records
Stone location
Time Frame: 2 weeks
patient's records
Urine color
Time Frame: 2 weeks
patient's records
Shock
Time Frame: 2 weeks
ESWL
Hydronephrosis grade
Time Frame: 2 weeks
* 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
Stone shape
Time Frame: 2 weeks
patient's records
Urine Specific Gravity
Time Frame: 2 weeks
patient's records
Stone-free rates (%)
Time Frame: 2 weeks
ESWL
Visual analog scale for pain
Time Frame: 2 weeks
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sung Yong Cho
Clinical Professor
Seoul National University Hospital