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

Ureteral Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730389
• Other study ID #: EPVL for 4-10mm ureteral stone
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2018
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, Ph.D and M.D.
• Phone: +86 13802916676
• Email: gzgyzgh[@]vip.tom.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: November 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 a-receptor, calcium channel blocker or chinese medicine stone shovel

7. Dysfunction of blood coagulation

8. Obese patients (body mass index > 28 kg / m2);

Related Conditions & MeSH terms

• Calculi
• Ureteral Calculi
• Ureterolithiasis

Intervention

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

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
Guohua Zeng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Stone Expulsion	The stone discharge rate of the two group	14 days
Secondary	Time to Stone Passage	Time to stone elimination in days in patients with spontaneous elimination	14 days
Secondary	The rate of renal colic	the mean rate of renal colic between the two groups	14 days
Secondary	Required Analgesics	the need for slow-released diclofenac tablet	14 days