Clinical trial NCT03730389: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ureteral Calculi
Keywords: Ureteral Calculi
External Physical Vibration Lithecbole (EPVL)
Efficacy
Safety
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: External Physical Vibration Lithecbole(EPVL) for ureteral stone
Primary purpose: TREATMENT

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.

Eligibility criteria: 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);

Primary outcomes:
measure: Number of Participants With Stone Expulsion
timeFrame: 14 days
Secondary outcomes:
measure: Time to Stone Passage
timeFrame: 14 days
measure: The rate of renal colic
timeFrame: 14 days
measure: Required Analgesics
timeFrame: 14 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Guohua Zeng, PH.D & MD
role: PRINCIPAL_INVESTIGATOR
References: