External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone

Study Overview
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Brief Summary
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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
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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.

Official Title
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External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial

Conditions
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Ureteral Calculi

Intervention / Treatment
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* Device: External Physical Vibration Lithecbole (EPVL)


Participation Criteria
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Eligibility Criteria
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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);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: External Physical Vibration Lithecbole(EPVL) for ureteral stone
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPVL Group<br>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. | Device: External Physical Vibration Lithecbole (EPVL)<br>* Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones<br>|
| No Intervention: Traditional Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stone Expulsion | The stone discharge rate of the two group | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Stone Passage | Time to stone elimination in days in patients with spontaneous elimination | 14 days | 
| The rate of renal colic | the mean rate of renal colic between the two groups | 14 days | 
| Required Analgesics | the need for slow-released diclofenac tablet | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral Calculi, External Physical Vibration Lithecbole (EPVL), Efficacy, Safety