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

November 2, 2018 updated by: Guohua Zeng

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guohua Zeng, Ph.D and M.D.
  • Phone Number: +86 13802916676
  • Email: gzgyzgh@vip.tom.cn

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Recruiting
        • Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Guohua Zeng, Ph.D & MD.
        • Contact:
        • Sub-Investigator:
          • Chao Cai, PH.D & MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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