Department of Urology, CHRU Tours, 37000, Tours, France.
Clinical Investigation Center, INSERM 1415, CHRU Tours, 37000, Tours, France.
Trials. 2024 Jul 4;25(1):455. doi: 10.1186/s13063-024-08309-0.
Lithiasis is a common and recurrent disease. Flexible ureteroscopy (fURS) is the cornerstone of laser treatment of kidney stones. Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created cannot be extracted using our surgical tools and may stay intra-renally at the end of the procedure. Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy. Nevertheless, the impact of adjuvant treatment after fURS remains unclear and mainly theoretical.
The primary objective is to show that the injection of 40 mg of furosemide in slow intravenous during 10 min, after the procedure, increases the stone-free rate 3 months after a fURS for destruction of kidney stones with laser.
METHODS/DESIGN: The study will be a two-parallel group randomized, controlled, multicentric trial with a blinding evaluation. Nine French departments of urology will participate. Patients will be randomized in 2 groups: the experimental group (injection of 40 mg of furosemide at the end of the surgery) and a control one (usual care). Patients will be followed up for 3 months (± 2 weeks) after the surgery. Then, we will perform a low dose abdomino-pelvic CT scan. The primary outcome is the stone-free rate at 3 months. A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results. The secondary outcomes will include the rate of early post-operative urinary tract infection (UTI), the evaluation of post-operative pain, and the safety of the use of furosemide in patients treated by fURS for renal stone laser destruction. As secondary objectives, it is also planned to look at the effect of the prescription of an alpha-blocker as usual treatment on stone-free rate and to assess the agreement between the imaging analysis of the urologist and the specialized radiologist.
Lithiasis is a public health problem. It affects about 10% of the general population. This prevalence is increasing (multiplied by 3 in 40 years), partly due to changes in the population's eating habits over the years. The lithiasis patient is a patient with a chronic disease requiring annual follow-up and who may suffer from multiple recurrences, with a recurrence rate at 5 years of 50%. Recurrences are partly due to residual fragments left in the kidneys at the end of the operation. Other risk factors for recurrence include dietary hygiene and the presence of an associated metabolic disease. The metabolic blood and urine tests recommended by the Association Française d'Urologie (AFU) can be used to manage these last two problems. As far as residual fragments are concerned, their presence leads to an early recurrence of stones because they form the bed for a new aggregation of crystals in the kidneys. Being able to reduce the rate of residual fragments in patients with the use of furosemide at the end of the intervention therefore seems essential in the management of recurrences in our patients. This will also improve our patients' quality of life. Indeed, lithiasis disease leads to chronic pain associated with acute pain that motivates consultations to the emergency for specialized management. This study is the first to evaluate the impact of forced diuresis with the use of furosemide on the stone-free rate after a fURS for destruction of kidney stone with laser.
ClinicalTrials.gov Identifier: NCT05916963 , first received: 22 June 2023. EU Clinical Trials Register EudraCT Number: 2022-502890-40-00.
结石病是一种常见且易复发的疾病。软性输尿管镜检查（fURS）是激光治疗肾结石的基石。肾结石的破坏需要将其激光粉碎成小碎片，以便通过输尿管将其取出，或改善其沿尿路的自发排出。然而，大多数情况下，使用我们的手术工具无法提取所有的微碎片和粉尘，这些碎片和粉尘可能会在手术结束时留在肾脏内。辅助治疗（如强制利尿、倒置或机械压力）以前曾被描述用于改善体外冲击波碎石术（ESWL）后结石碎片的排出。然而，fURS 后辅助治疗的影响仍不清楚，主要是理论上的。
主要目的是表明在激光破坏肾结石的 fURS 手术后 10 分钟内静脉缓慢注射 40mg 速尿可提高术后 3 个月的无石率。
方法/设计：该研究将是一项两平行组随机、对照、多中心试验，具有盲法评估。9 个法国泌尿科部门将参与该研究。患者将随机分为 2 组：实验组（手术结束时注射 40mg 速尿）和对照组（常规治疗）。患者将在手术后 3 个月（±2 周）进行随访。然后，我们将进行低剂量腹部骨盆 CT 扫描。主要结局是 3 个月时的无石率。两名专门的放射科医生将进行盲法和交叉的图像集中评估，以实现结果的同质化。次要结局将包括术后早期尿路感染（UTI）的发生率、术后疼痛的评估以及 fURS 治疗肾结石激光破坏患者使用速尿的安全性。作为次要目标，还计划观察常规使用α受体阻滞剂对无石率的影响，并评估泌尿科医生和专门放射科医生的影像学分析之间的一致性。
结石病是一个公共卫生问题。它影响了大约 10%的普通人群。这种患病率在增加（40 年内增加了 3 倍），部分原因是多年来人口饮食习惯的变化。结石病患者是一种慢性病患者，需要每年随访，并且可能多次复发，5 年内复发率为 50%。复发的部分原因是手术结束时肾脏内残留的碎片。其他复发的风险因素包括饮食卫生和存在相关代谢疾病。法国泌尿外科协会（AFU）推荐的代谢血液和尿液检测可用于管理后两个问题。就残留碎片而言，它们的存在导致结石早期复发，因为它们形成了肾脏中晶体新聚集的床。在干预结束时使用速尿降低患者残留碎片的比率，因此在我们患者的复发管理中似乎至关重要。这也将提高我们患者的生活质量。事实上，结石病会导致与促使患者因专业治疗而到急诊就诊的急性疼痛相关的慢性疼痛。这项研究是第一个评估在激光破坏肾结石的 fURS 手术后使用速尿进行强制性利尿对无石率的影响的研究。
ClinicalTrials.gov 标识符：NCT05916963，首次接收：2023 年 6 月 22 日。欧盟临床试验注册 EudraCT 编号：2022-502890-40-00。
