A Prospective Study to Compare the Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Stone-free status
研究概览
简要总结
This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.
详细描述
Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL).
Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years.
- •Both sexes.
- •Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.
排除标准
- •Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square).
- •Patients with renal insufficiency (creatinine more than 1.7 mg/dl).
- •Patients with active urinary tract infections.
研究组 & 干预措施
Oral dissolution therapy group
Patients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months.
干预措施: Oral dissolution therapy (Drug)
Extracorporeal shock wave lithotripsy group
Patients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks.
干预措施: Extracorporeal shock wave lithotripsy (Procedure)
Oral dissolution therapy + extracorporeal shock wave lithotripsy group
Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.
干预措施: Oral dissolution therapy + extracorporeal shock wave lithotripsy (Procedure)
结局指标
主要结局
Stone-free status
时间窗: 3 months after the procedure
To assess the stone-free status, which is characterized by no evidence of any residual stones in renal units by MSCT of the urinary tract (CTUT) at 3 months following oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), or combined ODT and ESWL.
次要结局
- Complication rate(3 months after the procedure)
研究者
Mohamed Ahmed Ateya
Lecturer of Urology, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University