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

Sponsor

Guohua Zeng (Other)

Overall Status

Unknown status

CT.gov ID

NCT03730389

Collaborator

(none)

208

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Device: External Physical Vibration Lithecbole (EPVL)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

External Physical Vibration Lithecbole(EPVL) for ureteral stoneExternal Physical Vibration Lithecbole(EPVL) for ureteral stone

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPVL Group 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) Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
No Intervention: Traditional Group 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.

Arm

Intervention/Treatment

Experimental: EPVL Group

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)

Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones

No Intervention: Traditional Group

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.

Outcome Measures

Primary Outcome Measures

Number of Participants With Stone Expulsion [14 days]
The stone discharge rate of the two group

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);