External Physical Vibration Lithecbole(EPVL) Versus Traditional Row of Stone After Retrograde Intrarenal Surgery(RIRS)

Renal Calculi Clinical Trial

Official title:

External Physical Vibration Lithecbole(EPVL) Contrast With the Traditional Row of Stone Effect After Retrograde Intrarenal Surgery(RIRS): A Multi-center Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02645708
• Other study ID #: MRER(54)2015
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2015
• Last updated: February 13, 2017
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, PH.D and M.D
• Phone: +86 13802916676
• Email: gzgyzgh[@]vip.tom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely, hastening fragments clearance just only rely on traditional expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive therapy and changing body position. Therefore, researchers purpose to evaluate the effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual fragments after RIRS by prospective study of clinical trial, which will improve stone-free rate of residual fragments and benefit more patients.

Description:

To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone after the operation of RIRS，thereby improving 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 July 2016. One hundred and eighty patients with postoperative residual stone after RIRS 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 RIRS.

The principle of extracorporeal physical vibration:

A Simple harmonic motion technology in multi-direction was applied. The Lateral acceleration was provided by the physical vibration device in the base through the harmonic vibration wave in the horizontal direction, which induces the urinary stone separate with the kidney or ureter, and expands a moving space for the stone. Meanwhile, an axial effect was produced to push the stone by the physical vibration device in the handle through the harmonic vibration wave in the multi- direction. Finally, with the help of changing the position and direction of the extracorporeally physical vibration machine, the urinary stone was discharged from the urinary collecting system.

Number:

180cases(90 cases in control group, 90 cases in EPVL group)

Grouping methods:

In this trial, investigators use equilibrium randomization methods that generate random numerical code table, according to the table, patients are randomly assigned to different groups.

Evaluating indicator Stone-free rate in 5 weeks after RIRS. Incidence rate of complications and adverse reactions after EPVL(fever, hematuria).

Trial method; Cases selection and grouping: in 1 week after RIRS, the imaging KUB(abdominal plain film), patients with radiolucent calculus need to be examined by CT demonstrate the presence of residual fragments, and the cases that meeting inclusion criterion are randomly assigned to groups, and the ureteral stent should be removed in 2 weeks;

Laboratory testing: blood routine, urine routine, renal function , coagulation function; Strat the treatment of EPVL before the removal of ureteral stent.

Methods of control group(group1):

RIRS without EPVL Patients should be reexamined respectively in 1 and 2 weeks after RIRS, and the ureteral stent should be removed in 2 weeks;

Patients should follow the measures below:

1. the amount of fluid intake is more than 2000ml/d

2. increase physical activity

3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body;

Follow up timing: respectively in 2 ,3 and 5 weeks after RIRS.

Methods of EPVL group(group2):

Preparation before EPVL: the amount of fluid intake is about 1000-2000ml, start the treatment of EPVL when patient's bladder is filling;

Record: patients' information, outcome of treatment (examined by KUB right after EPVL); Start the treatment of EPVL;

Patients should follow the measures below:

1. the amount of fluid intake is more than 2000ml/d

2. increase physical activity

3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body;

Patients should be reexamined in one week, meanwhile removing ureteral stent or perhaps undergoing the treatment of EPVL once again.

Follow up timing: respectively in 1,2 and 4 weeks after EPVL..

Follow up project Laboratory testing: routine urinalysis; Imaging examination: KUB or kidney CT scan (radiolucent calculus) Complications and adverse reactions. Data gathering Fill in follow up table data; Radiological images; IVP(intravenous pyelography) or kidney CT scan; Reexamined by KUB (radiopaque calculus) or CT (radiolucent calculus) right after RIRS, respectively in 2 ,3 and 5 weeks after RIRS. If stones have been eliminated completely in patients with radiolucent calculus before or at the fourth week of follow-up, investigator must provide kidney CT scan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age of 18-65 years;

2. The imaging demonstrate the presence of residual fragments in 1 week after RIRS;

3. Renal or upper ureteral calculus;

4. There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;

5. Stones are fragmented successfully on single session of RIRS, and the diameter of any of fragments is less than 4mm;

6. Normal renal function.

Exclusion Criteria:

1. Couldn't tolerate EPVL;

2. Urinary tract anomalies, stricture or obstruction;

3. Calculus in diverticulum;

4. Severe hydronephrosis;

5. Combined with acute urinary tract infection;

6. Coagulation abnormalities;

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Procedure:
• Retrograde Intrarenal Surgery
Patients undergo Retrograde Intrarenal Surgery
• EPVL after RIRS
Patients in Group 2 undergo EPVL after RIRS

Locations

Country	Name	City	State
China	Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from stone free rate(SFR) with different follow-up periods	Primary SFR is assessed by abdominal plain film (KUB)at2,3,5 week after operation. Stone-free status are defined as either the absence of any residual stone fragments.	return hospital respectively in 2,3 and 5 week after RIRS
Secondary	extracorporeal physical vibration complications	Complication is defined as any adverse event occurred	return hospital respectively in 2 ,3 and 5 weeks after RIRS