The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol
研究概览
简要总结
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented.
详细描述
Patients with renal stones, seen through the outpatient clinic in the urology department or post primary intervention for renal stones, will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study. If they agree, they will be asked to sign an informed consent.
Baseline patients' assessment will include;
-
Full history taking including
-
Previous stone history regarding presentation and management
-
Previous trial oral dissolution therapy for renal stones and their compliance to the treatment
-
Previous GIT surgery
-
History of chronic medical or metabolic illness e.g; DM
-
Clinical examination including
o Body mass index (BMI)
- Laboratory investigations including;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' criteria:
- •Ability to give informed consent.
- •Age more than 18 years.
- •Absence of significant hydronephrosis, serious urinary tract infection, congenital anomalies or distal ureteric obstruction in the affected renal unit.
- •Normal cardiac, hematological, and renal functions.
- •Stone criteria:
- •Primary or recurrent renal stone.
- •Patients with residual renal stones after primary intervention whether open surgery, endoscopic or ESWL.
- •Peripheral calyceal stones or stone in the renal pelvis with no significant hydronephrosis.
- •Stone size less than 3 cm in maximum diameter
- •Stones with radiodensity less than 600 Hounsefield units attenuation in Non Contrast Computed Tomography (NCCT).
排除标准
- •Patients' criteria:
- •Inability to give informed consent.
- •Age less than 18 years
- •Patients with unremitting pain or serious urinary tract infection.
- •Presence of significant hydronephrosis, congenital anomalies or distal ureteric obstruction in the affected renal unit.
- •Abnormal cardiac, hematological or renal functions.
- •Stone criteria:
- •Obstructing stone in the renal pelvis with significant hydronephrosis.
- •Assumption of presence of calcium stones by presence of calcification in the stone in plain X-rays.
研究组 & 干预措施
Study group
Eligible patients, who fulfilled the study criteria, will be instructed For;
- Oral alkalinization
- Potassium citrate 20 mEq three times daily
- Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
- Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
- Dietary recommendations
In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ;
- Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.
干预措施: Oral alkalinization (Potassium citrate, Allopurinol) (Drug)
Study group
Eligible patients, who fulfilled the study criteria, will be instructed For;
- Oral alkalinization
- Potassium citrate 20 mEq three times daily
- Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
- Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
- Dietary recommendations
In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ;
- Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.
干预措施: Life style modification (Behavioral)
Study group
Eligible patients, who fulfilled the study criteria, will be instructed For;
- Oral alkalinization
- Potassium citrate 20 mEq three times daily
- Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
- Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
- Dietary recommendations
In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ;
- Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.
干预措施: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables) (Dietary Supplement)
结局指标
主要结局
The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol
时间窗: participants will be followed for the duration of medical treatment which is specified to be 3 months
The stone surface area will be measured using the formula; Surface area = length X width X 0.25 X (22/7) Comparison of the stone surface area in relation to the initial surface area will be done.
次要结局
- Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment(participants will be followed for the duration of medical treatment which is specified to be 3 months)
研究者
Amr Abdel-Lateif El-Sawy
Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt
Mansoura University