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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stone Expulsion | The stone discharge rate of the two group | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Stone Passage | Time to stone elimination in days in patients with spontaneous elimination | 14 days |
| The rate of renal colic | the mean rate of renal colic between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohua Zeng, Ph.D and M.D. | Contact | +86 13802916676 | gzgyzgh@vip.tom.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guohua Zeng, PH.D & MD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510230 | China |
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| ID | Term |
|---|---|
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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External Physical Vibration Lithecbole(EPVL) for ureteral stone
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| 14 days |
| Required Analgesics | the need for slow-released diclofenac tablet | 14 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |