External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone
Primary Purpose
Ureteral Calculi
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
External Physical Vibration Lithecbole (EPVL)
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Calculi focused on measuring Ureteral Calculi, External Physical Vibration Lithecbole (EPVL), Efficacy, Safety
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 to 70 years
- 4-10 mm single ureteral calculi
- Normal serum creatinine
- ASA grading: 1-2 levels.
Exclusion Criteria:
- Pregnant or isolated kidney patients
- Moderate or severe hydronephrosis
- History of ureteral stricture
- Multiple ureteral stones;
- Acute urinary tract infection
- Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
- Dysfunction of blood coagulation
- Obese patients (body mass index > 28 kg / m2);
Sites / Locations
- Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EPVL Group
Traditional Group
Arm Description
In treatment group, patients were given one to three sessions of External Physical Vibration Lithecbole therapy in two weeks. These patients were also instructed to drink a minimum of 2500 ml water daily and take more exercise.
patients with 4-10mm ureteral stone, were treated by traditional treatment methods, including drinking a minimum of 2500 ml water daily and taking more exercise.
Outcomes
Primary Outcome Measures
Number of Participants With Stone Expulsion
The stone discharge rate of the two group
Secondary Outcome Measures
Time to Stone Passage
Time to stone elimination in days in patients with spontaneous elimination
The rate of renal colic
the mean rate of renal colic between the two groups
Required Analgesics
the need for slow-released diclofenac tablet
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03730389
Brief Title
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone
Official Title
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guohua Zeng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator aims to perform a prospective and randomized controlled trial evaluating the safety and efficacy of External Physical Vibration Lithecbole(EPVL) in treating 4-10 mm ureteral stone.
Detailed Description
Patients with ureteral stones less than 10 mm, would receive observation for stone passage, not requiring immediate surgery. There are many studies evaluating the effect of Medical expulsive therapy in treating ureteral stones, including a-blockers, and calcium channel blockers. Most of shuties concluded that the benefit of a-blockers might be among those with larger (distal) stones. There is no good method for the removal of upper ureteral calculi, except drinking water and exercising.
Recently, a new extracorporeal physical vibrational lithecbole (EPVL) device named Friend-I EPVL (Zhengzhou Fu Jian Da Medical Instrument Co., Zhengzhou, China) has proven to be an effective treatment for upper urinary tract residual calculi. The device was approved by the Chinese food and drug administration in 2012. 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. So, we think that EPVL may be effective in treating ureteral stones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi
Keywords
Ureteral Calculi, External Physical Vibration Lithecbole (EPVL), Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
External Physical Vibration Lithecbole(EPVL) for ureteral stone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EPVL Group
Arm Type
Experimental
Arm Description
In treatment group, patients were given one to three sessions of External Physical Vibration Lithecbole therapy in two weeks. These patients were also instructed to drink a minimum of 2500 ml water daily and take more exercise.
Arm Title
Traditional Group
Arm Type
No Intervention
Arm Description
patients with 4-10mm ureteral stone, were treated by traditional treatment methods, including drinking a minimum of 2500 ml water daily and taking more exercise.
Intervention Type
Device
Intervention Name(s)
External Physical Vibration Lithecbole (EPVL)
Intervention Description
Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
Primary Outcome Measure Information:
Title
Number of Participants With Stone Expulsion
Description
The stone discharge rate of the two group
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to Stone Passage
Description
Time to stone elimination in days in patients with spontaneous elimination
Time Frame
14 days
Title
The rate of renal colic
Description
the mean rate of renal colic between the two groups
Time Frame
14 days
Title
Required Analgesics
Description
the need for slow-released diclofenac tablet
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18 to 70 years
4-10 mm single ureteral calculi
Normal serum creatinine
ASA grading: 1-2 levels.
Exclusion Criteria:
Pregnant or isolated kidney patients
Moderate or severe hydronephrosis
History of ureteral stricture
Multiple ureteral stones;
Acute urinary tract infection
Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
Dysfunction of blood coagulation
Obese patients (body mass index > 28 kg / m2);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, Ph.D and M.D.
Phone
+86 13802916676
Email
gzgyzgh@vip.tom.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, PH.D & MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD.
Phone
+86 13802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD.
First Name & Middle Initial & Last Name & Degree
Chao Cai, PH.D & MD
12. IPD Sharing Statement
Plan to Share IPD
No
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External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone
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