Active clinical trials for "Nephrolithiasis"

Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients. Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.

The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm. Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates. To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.

currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm. the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 18 weeks of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, the evolution of renal function, the cohort at Baseline and after 4 months of treatment period, the safety of fluconazole, the onset of potential mycological resistances, and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 60 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.

This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.

The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery. Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm. Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²

To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy

Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless PCNL surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.

The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients. The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.