External Physical Vibration Lithecbole Contrast With the Traditional Row of Stone Effect After ESWL: A Multi-center Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Stone free rate (SFR)
Study Overview
Brief Summary
The traditional stone row method comprises increasing exercise, drink lots of water, drug row of stone and stone row position. External physical vibration lithecbole(EPVL) is a non-invasive device active row of stone, the researchers hope that through this test prospective clinical study to evaluate the effectiveness of in vitro physical vibration row of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged, thereby improving after ESWL stone clearance rate.
Detailed Description
To evaluate the efficacy and safety of external physical vibration lithecbole(EPVL) for the treatment after ESWL treatment of stones discharged，thereby improving after extracorporeal shockwave lithotripsy(ESWL) stone clearance rate. Investigators will do a multi-centers randomized controlled trial(RCT)，and investigators plan to perform this study in 10 hospitals，which are the First Affiliated Hospital of Guangzhou Medical University of China, Department of Urology, The Second Affiliated Hospital of Zhengzhou University of China, Jiangsu Province Hospital, Hubei Province Hospital, Zhongshan Hospital, Tongji Hospital,Hubei provincial people's Hospital,Guilin 181 Hospital，the People' Hospital of Huzhou，The People' Hospital of Shaoyang.
Investigators plan to beginning their study August 2015 and end at July 2016. One hundred and eighty patients with ESWL postoperative residual stone will be enrolled in this study. By simple random sampling technique, all the patients will be assigned to the segment of natural stone row group or physical row of stone group, compared two groups of patients with stone clearance rate and complications, Investigators hope that through this test, improve stone clearance rate after ESWL.
Number:
180cases(90 cases in control group, 90 cases in EPVL group)
Grouping methods:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of 18-65 years;
- •The diameter of calculus is less than or equal to 15mm;
- •Renal or upper ureteral calculus;
- •There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
- •Stones are fragmented successfully on single session of ESWL, and the diameter of any of fragments is less than 6mm;
- •Normal renal function,
Exclusion Criteria
- •Couldn't tolerate EPVL;
- •Urinary tract anomalies, stricture or obstruction;
- •Calculus in diverticulum;
- •Severe hydronephosis;
- •Combined with acute urinary tract infection;
- •Coagulation abnormalities;
- •Morbid obesity(BMI>35kg/m2);
- •Patients with ureteral stent;
- •Stones aren't fragment successfully, or the diameter of at least one fragment is more than 6mm ;
Outcomes
Primary Outcomes
Stone free rate (SFR)
Time Frame: return hospital respectively in 1,2 and 4 weeks after ESWL
Primary SFR is assessed by abdominal plain film （KUB）at 1,2,4 weeks after ESWL. Stone-free status are defined as either the absence of any residual stone fragments.
Secondary Outcomes
- extracorporeal physical vibration complications(return hospital respectively in 1,2 and 4 weeks after ESWL)
Investigators
Guohua Zeng
Vice President of the Hospital
The First Affiliated Hospital of Guangzhou Medical University