Clinical Research Directory

Gut Oxalate Absorption in Calcium Oxalate Stone Disease

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time * ingest a soluble form of oxalate and sugar preparations to test gut permeability * collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time * collect urine, blood and stool samples during the fixed diets * ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will ingest fixed diets containing low amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test

A Study on the Application of NE Irrigation Fluid for Hemostasis in Flexible Ureteroscopic Lithotripsy: A Prospective Single-arm Interventional Study of Upper Urinary Tract Calculi.(NE: Norepinephrine)

Urinary stone disease is globally prevalent with rising incidence and recurrence, imposing heavy socioeconomic burdens. Flexible ureteroscopy has advanced stone treatment. Single-use flexible ureteroscopes (su-fURS) combined with negative pressure ureteral access sheath (NPUAS), recommended by urology guidelines, improve surgical safety and stone-free rates and can treat stones ≤3 cm. However, su-fURS has poorer image quality, bleeding during lithotripsy may blur vision, frequently impairing efficiency and safety. Norepinephrine (NE), a tyrosine-derived sympathomimetic amine, mainly activates α1 and β1 receptors. Doses above 3 μg/min trigger predominant α1-mediated vasoconstriction of arteries and veins. It can act on mucosal surfaces via irrigation fluid, making it favorable for initial hemostasis of injured mucosa. Firstly, this study aims to evaluate the efficacy and safety of low-concentration norepinephrine (NE) irrigation solution for hemostasis during lithotripsy performed with single-use flexible ureteroscope (su-fURS) combined with NPUAS, fifteen subjects will be enrolled in the study. Secondly, we explore the dose-effect relationships of four concentrations: 2 mg/3 L, 4 mg/3 L, 6 mg/3 L and 8 mg/3 L, and determine the optimal concentration by comprehensively evaluating hemostatic efficacy and safety. A total of 40 subjects will be enrolled, with 10 subjects in each concentration.

IAU Percutaneous Nephrolithotripsy Study

During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS). This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.

Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS

The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.

Long-term Safety of UAS-assisted vs Sheathless RIRS in Non-prestented Patients

This retrospective comparative cohort study will include adult patients who underwent primary RIRS for renal stones ≤20 mm at Al-Azhar University Hospitals between January 2020 and December 2025. Patients will be classified by whether a ureteral access sheath (UAS) was used during the index RIRS, and all eligible patients will be invited for active long-term follow-up (minimum 12 months) to assess the composite outcome of delayed ipsilateral ureteral stricture or new/progressive ipsilateral hydronephrosis and other safety and efficacy outcomes. Propensity-score methods and adjusted regression analyses will be used to control confounding.

Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)

Background: Ureteral stent-related symptoms vary considerably among patients despite similar surgical procedures and stent characteristics. Although several mechanisms have been proposed, the reasons for this interindividual variability remain incompletely understood. Pelvic floor muscle endurance may represent one of the patient-related factors contributing to symptom severity. The Pelvic Floor Fatigue Index (PFFI) is a novel ultrasound-based index developed to quantify pelvic floor muscle endurance by measuring the percentage decline in bladder base elevation during a sustained maximum voluntary pelvic floor contraction using suprapubic transverse B-mode ultrasonography. This prospective observational study aims to clinically evaluate the PFFI by investigating the association between preoperative PFFI measurements and postoperative ureteral stent-related symptoms assessed using the Ureteral Stent Symptom Questionnaire (USSQ). In addition, the study will evaluate the test-retest reliability of the PFFI measurement method and explore its potential role as an objective functional assessment tool for pelvic floor muscle endurance. The findings of this study are expected to provide the first clinical evaluation of the PFFI and establish the methodological basis for future validation studies and broader clinical applications.

Nurse-Led Patient Education in ESWL Patients

Urolithiasis is a significant health problem characterized by the formation of stones in urinary system organs such as the kidneys, ureters, and bladder, and its prevalence is increasing worldwide. It is reported that its prevalence varies between 1% and 20% due to geographical, diet-related, genetic, and climatic factors, and it shows a recurrence rate of approximately 50%. Urolithiasis is the third most common pathology in urology after urinary tract infections and prostate diseases and is closely related to multiple factors such as the increase in the prevalence of metabolic syndrome, dietary habits, inadequate fluid intake, physical inactivity, obesity, and climate change. This situation increases the clinical burden of the disease, leading to a decrease in the quality of life of individuals and the development of various physical and psychological problems during the treatment process. Extracorporeal shock wave lithotripsy (ESWL) is a widely used non-invasive method in the treatment of urolithiasis. ESWL uses shock waves to break kidney stones into smaller pieces, which are then passed through the urinary tract. Current urolithiasis guidelines emphasize that treatment selection should be individualized, taking into account the stone's size and location, as well as its density and the patient's anatomical conditions. According to guidelines published by the European Association of Urology and the American Urological Association, ESWL or retrograde intrarenal surgery (RIRS) are among the primary treatment options for kidney stones smaller than 20 mm, while percutaneous nephrolithotomy (PCNL) is recommended for kidney stones 20 mm and larger. In addition, it recommends ESWL as the first-line treatment for lower calyx stones smaller than 10 mm, provided that the appropriate stone composition and anatomical conditions are met. The current literature shows that ESWL has complication rates similar to or lower than those of ureteroscopic lithotripsy (URSL), RIRS, and PCNL and offers shorter hospital stays. However, uncertainties regarding the patient experience, including treatment success and the need for retreatment, remain. Although ESWL is generally considered a safe and effective method, uncertainties regarding the procedure and insufficient information can cause increased anxiety in patients.Increased anxiety levels can heighten pain perception, thereby increasing the need for analgesics and negatively affecting treatment compliance. Furthermore, complications such as pain, hematuria, nausea and vomiting, and infection that may occur in the post-procedure period can lead to a decrease in patients' quality of life and repeated visits to healthcare facilities. The role of nurses in the pre- and post-procedure care of patients undergoing ESWL treatment extends beyond technical care to include improving the patient's experience through patient education and psychosocial support. Nurses make significant contributions by identifying potential contraindications to ESWL, planning appropriate patient preparation, and enhancing procedure safety through comprehensive pre-procedure assessments. In addition, patient education led by nurses plays a critical role in increasing patients' knowledge and awareness of lifestyle adjustments and preventive approaches to reduce the recurrence of urolithiasis. A review of the current literature reveals a limited number of studies that jointly evaluate the effect of structured patient education led by nurses on key psychosocial outcomes, such as anxiety levels and quality of life, in patients undergoing ESWL treatment. This situation underscores the need for interventional studies to assess the comprehensive effects of these educational interventions on patient-centered outcomes.

Pain Control During ESWL Using Non-Opioid Analgesics

This prospective randomized controlled trial aims to compare the analgesic efficacy of three non-opioid analgesics (ibuprofen, paracetamol, and tenoxicam) during extracorporeal shock wave lithotripsy (ESWL). All patients undergoing ESWL will be randomly assigned into four groups including a placebo group. Pain intensity will be assessed using the Visual Analog Scale (VAS) at the 5th, 10th, 15th, and 20th minutes during the procedure. In addition to comparing analgesic efficacy, the study will evaluate patient-related and stone-related factors affecting pain perception, including body mass index, subcutaneous fat thickness, and stone density measured by Hounsfield Units. The study also aims to assess the relationship between analgesic efficacy, energy levels applied during ESWL, and treatment outcomes such as stone-free rates. The findings may contribute to optimizing individualized pain management strategies and improving treatment efficiency in ESWL procedures.

Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.

Predicting the Success of Flexible Ureterorenoscopy for Kidney and Upper Ureter Stones

This observational study aims to test how well a specific medical scoring tool, called a nomogram, can predict the success of a common minimally invasive surgery for kidney stones. The surgery being studied is flexible ureterorenoscopy (fURS), which is widely used to treat stones in the kidney and the upper part of the ureter. In this study, procedural success is defined as a patient being completely stone-free after their surgery. While fURS is highly effective, the chances of completely clearing all stones can vary from person to person based on individual factors like stone size, stone volume, and anatomical characteristics. Researchers want to determine if this nomogram can accurately estimate a patient's personalized chance of achieving a stone-free outcome before the intervention takes place. Participants in this study will be adult patients who are already scheduled to undergo fURS as part of their standard medical care. Because this is an observational study, there are no experimental treatments, participants will receive their normal surgical care. During the study, the research team will collect standard clinical information, including: * Preoperative data such as age, body mass index (BMI), blood tests, and CT scan results. * Operative details during the surgery, such as the time it takes, the experience level of the surgeon, and the laser settings used to break up the stones. * Postoperative outcomes, specifically reviewing follow-up imaging to check for the presence and size of any remaining stone fragments. By comparing the nomogram's preoperative predictions to the patients' actual surgical results, the researchers hope to validate the tool's accuracy. Confirming the reliability of this tool could help doctors better plan individualized treatments, avoid unnecessary procedures, and improve how they counsel future patients regarding their expected surgical outcomes.

DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis

A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

Ultrasound Imaging of Kidney Stones and Lithotripsy

The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.

Effects of Virtual Reality Education on Anxiety and Learning in Patients Undergoing Urolithiasis Surgery

This randomized controlled trial aims to evaluate the effects of two-tier virtual reality-based preoperative education on anxiety, learning knowledge, self-care ability, and cognitive load in patients undergoing urolithiasis surgery. Participants will be randomly assigned to routine education, standard virtual reality education, or two-tier virtual reality education groups. Outcomes will be assessed using anxiety scales, knowledge questionnaires, self-care ability measures, and cognitive load assessments before and after the intervention.

PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

Extracorporeal shockwave lithotripsy (ESWL) is a non-invasive standard treatment for kidney stones. This study will be conducted to evaluate the effectiveness of ESWL using MODULITH® SLX-F2 with stone tracking, compared to MODULITH® SLX-F2 without stone tracking, in adult patients with kidney stones, as measured by stone-free status.

Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.

Efficacy of Different Modalities on Management of Renal Hard Stones

The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

This study tests moving kidney stones using focused ultrasound (referred to as ultrasonic propulsion). The study includes multiple population groups to investigate the ability of our technology to: a) move stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.

Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents. Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac. Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis. Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.

Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

A Prospective Analysis of Thulium Fiber Laser Efficiency

Patients diagnosed with urolithiasis will be prospectively enrolled in this study. Preoperative diagnostic assessment will be performed using computed tomography (CT). Key parameters, including stone dimensions, quantity, total stone burden, and stone density (Hounsfield units), will be evaluated preoperatively. This study aims to analyze data from patients who undergo ureteroscopic Thulium Fiber Laser (TFL) lithotripsy and achieve a stone-free status within a single procedural session. Based on these data, a 'Specific Energy Coefficient' will be derived to enable the preoperative prediction of the total laser energy required for successful lithotripsy.

SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.