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

NCT03730389 | Unknown

• 1 other identifier: EPVL for 4-10mm ureteral stone
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Calculi

Keywords

Ureteral Calculi; External Physical Vibration Lithecbole (EPVL); Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Stone Expulsion

  The stone discharge rate of the two group

  14 days

Secondary Outcomes (3)

• Time to Stone Passage

  14 days

• The rate of renal colic

  14 days

• Required Analgesics

  14 days

Study Arms (2)

EPVL Group

EXPERIMENTAL

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)

Traditional Group

NO INTERVENTION

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.

Interventions

External Physical Vibration Lithecbole (EPVL) DEVICE

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

EPVL Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Guohua Zeng: lead

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Guohua Zeng, PH.D & MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohua Zeng, Ph.D and M.D.

CONTACT

+86 13802916676; gzgyzgh@vip.tom.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president

Model Details: External Physical Vibration Lithecbole(EPVL) for ureteral stone

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)