Clinical Research Directory

Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)

This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.

Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm

This randomized controlled trial aims to compare the efficacy and safety of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus a standard ureteral access sheath during flexible ureterorenoscopy (FURS) in pediatric patients with renal stones less than 2 cm. The study will evaluate stone-free rates. operative time. intraoperative parameters. operative and postoperative complication and the need for any auxiliary procedures. Sixty pediatric patients will be randomly allocated into two equal groups and treated at the Urology Department, Tanta University.

Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.

Flexible ureteroscopy is characterized as first-line therapy for renal stones \< 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events. Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.

Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention

The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones. Study interventions: * Empagliflozin 10 mg once daily per os for 36 months * Personalized dietary counseling for 36 months. Control interventions: * Placebo once daily per os for 36 months * Generic dietary counseling for 36 months.

Tract Closure in PCNL

This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.

Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.

Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain. Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently. This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types. The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.

Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy

People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain. This study compares two different concentrations of bupivacaine, a local anesthetic medication, used during ESPB. Participants undergoing PNL will receive either 0.25% or 0.375% bupivacaine as part of their pain management. Researchers will compare pain scores, the need for additional pain medication, and changes in blood markers related to inflammation after surgery. The aim of the study is to determine whether one concentration provides better pain control or influences the inflammatory response differently after PNL.

Supine vs. Prone PCNL for Large Renal Stones: A Randomized Trial in Yemen.

The goal of this clinical trial is to compare the safety, cost-effectiveness, and patient recovery of two different surgical positions for percutaneous nephrolithotomy (PCNL) in adults aged 18 to 70 years who have kidney stones larger than 2 cm. The main questions it aims to answer are: * Does the supine (lying on the back) surgical position result in fewer early postoperative complications than the traditional prone (lying on the stomach) position? * Does the supine position reduce the total surgery time, direct hospital costs, and postoperative pain? Researchers will compare patients assigned to undergo PCNL in the supine position to those assigned to the prone position to see if the supine approach offers a safer, more cost-effective, and more comfortable recovery. Participants will: * Undergo standard PCNL surgery to remove their kidney stones in either the supine or prone position. * Have their pain levels, surgery time, and any early surgical complications monitored during their hospital stay. * Complete brief questionnaires regarding their overall surgical satisfaction and quality of life at 1 month and 3 months after the procedure.

Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

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.

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

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

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

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.

ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach

Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure. Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration. Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.

HoYAG vs TFL in miniPCNL With ClearPetra

Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.

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.

Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure

Stone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment for upper tract stone disease. Ureteral stenting is a common practice after ureteroscopy and placed in \~75% of cases to prevent ureteral edema and renal obstruction. Unfortunately, ureteral stenting can be very painful and has been shown to increase the rate of emergency room visits. Many strategies have been attempted to decrease pain with ureteral stenting including modification of stent material and designs, but efforts so far have been unsuccessful in decreasing stent-related morbidity. Stent-related morbidity is hypothesized to be secondary to irritation of ureteral/bladder mucosa and muscle. Analgesics such as alpha blockers and NSAIDs have been shown to reduce stent morbidity. Anticholinergic drugs are also utilized as they decrease bladder spasms and, therefore, are hypothesized to reduce stent irritation. However, the evidence for anticholinergics has been conflicting. Anticholinergics also have a serious side effect profile including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and even dementia. Some authors even hypothesize that these side effects may offset any purported benefits the anticholinergics provide for stent-morbidity. Methocarbamol is anti-spasmodic muscle relaxant that is believed to work by acting on central neurons and possibly by blocking sodium channels. Given that anticholinergics have many side effects and questionable efficacy, the investigators hypothesize that methocarbamol may achieve superior analgesia for stent morbidity and stent-related bladder spasms. Oxybutynin is used for the treatment of overactive bladder. The rationale is that the oxybutynin relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination caused by the urinary stent irritation. Since anticholinergics have multiple side effects, finding an equally efficacious alternative with less side effects is highly desirable. This study will evaluate the clinical and demographic factors of patients undergoing ureteroscopy and treated postoperatively with methocarbamol vs. oxybutynin for stent-related morbidity. Additionally, the study will aim to understand the postoperative outcomes and complication rates of patients discharged with methocarbamol vs. oxybutynin after ureteroscopy with a ureteral stent in place.

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.

Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients

This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic. The study enrolls 150 adult patients (75 men and 75 women), aged 40-70 years, who are prescribed KLP for indications VIII/1 (recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract), VIII/2 (nephrolithiasis without urinary tract obstruction, nephrocalcinosis), VIII/3 (conditions after kidney and urinary tract surgery), and VIII/4 (chronic prostatitis or prostatovesiculitis resistant to pharmacological treatment). The spa treatment consists of the use of natural healing resources of Mariánské Lázně, including a mineral spring drinking cure, balneotherapy (mineral water baths), peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy. The standard treatment duration is 21 days, during which each patient receives a total of 63 therapeutic procedures and drinks mineral spring water three times daily. Patients undergo assessments at the beginning (days 1-3) and at the end (days 19-21) of their treatment. Assessments include physical examination, abdominal and urinary tract ultrasound, blood and urine sampling with laboratory analysis, body composition measurement using bioelectrical impedance analysis (InBody), and psychometric questionnaire surveys. The primary aim of the study is to objectively assess the therapeutic effect of comprehensive spa care on nephrological and urological diseases by comparing pre-treatment and post-treatment clinical, laboratory, and patient-reported outcomes. The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (decision of November 2, 2023, ref. no. 437/23).

Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of RIRS on Early Postoperative Outcomes

The purpose of this study is to evaluate whether actively suctioning the renal collecting system to induce a "collapse" state at the end of retrograde intrarenal surgery (RIRS) can reduce postoperative pain and infection in patients with kidney stones. Participants will be randomly assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage). The study aims to determine if this simple surgical modification can improve early recovery outcomes and patient satisfaction.

DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones

Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure. Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques. This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate. The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.

FANS vs CVAC for Medium to Large Stones

Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other