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

Guohua Zeng

Status: Unknown

Conditions: Ureteral Calculi

Treatments: Device: External Physical Vibration Lithecbole (EPVL)

Study type: Interventional

Funder types: Other

Identifiers

NCT03730389

EPVL for 4-10mm ureteral stone

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults age 18 to 70 years
2. 4-10 mm single ureteral calculi
3. Normal serum creatinine
4. ASA grading: 1-2 levels.

Exclusion criteria

1. Pregnant or isolated kidney patients
2. Moderate or severe hydronephrosis
3. History of ureteral stricture
4. Multiple ureteral stones;
5. Acute urinary tract infection
6. Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
7. Dysfunction of blood coagulation
8. Obese patients (body mass index > 28 kg / m2);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

EPVL Group

Experimental group

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.

Treatment:

Device: External Physical Vibration Lithecbole (EPVL)

Traditional Group

No Intervention group

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.