A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.

Study Overview
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Brief Summary
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The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.

Detailed Description
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2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation. Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded. Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested. Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.

Official Title
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Department of Urology, Shanghai Xu-hui Central Hospital

Conditions
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Hypouricemia, Renal, Urolithiasis

Intervention / Treatment
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* Drug: Febuxostat 40mg Tab
* Behavioral: Non-drug control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form. .No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days. .Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days. Serum uric acid value ≥480 µmol / L urinary stones Exclusion Criteria: Transplanted kidney Fever or urinary tract infection is not treated according to the inclusion criteria Pregnant women and female menstruation Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure Patients with renal insufficiency Clcr <30 mL/min Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). For non-drug control group: Patients are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. Uric acid drug control group:or the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 20 mg three times a week
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uric acid drug control group<br>For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week | Drug: Febuxostat 40mg Tab<br>* For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.<br>|
| Active Comparator: Non-drug control group<br>They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. | Behavioral: Non-drug control group<br>* All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone burdern stone burdern | Use ultrasound or kub or CT plain scan to follow up the patients. | Change from the base line of the stone's volume and quantity at 3 months. | 
| Stone burdern stone burdern | Use ultrasound or kub or CT plain scan to follow up the patients. | Change from the base line of the stone's volume and quantity at 6 months. | 
| Stone burdern stone burdern | Use ultrasound or kub or CT plain scan to follow up the patients. | Change from the base line of the stone's volume and quantity at 12 months. | 
| Stone burdern stone burdern | Use ultrasound or kub or CT plain scan to follow up the patients. | Change from the base line of the stone's volume and quantity at 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | Total and partial renal function | Change from the base line of GFR at 6 months after the operation. | 
| Renal function | Total and partial renal function | Change from the base line of GFR at 12 months after the operation. | 
| Renal function | Total and partial renal function | Change from the base line of GFR at 18 months after the operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stone prevention, Renal function, Febuxostat