Nephrolithiasis – Trials in Disease

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Ongoing Clinical Trials for Nephrolithiasis

There are currently 4 clinical trials investigating new treatments and procedures for nephrolithiasis (also known as kidney stones). These studies are taking place across Europe, including Sweden, France, and Denmark, and focus on improving pain management during surgery, enhancing stone clearance after procedures, and evaluating medication combinations to help patients pass stone fragments more effectively.

Clinical trial locations

Study on Spinal Morphine, Intravenous Lidocaine, and Bupivacaine for Patients Undergoing Robot-Assisted Surgery for Kidney or Ureter Conditions

This trial, conducted in Sweden, explores different pain management strategies for patients undergoing robot-assisted surgery for kidney or ureter conditions, including kidney stones.

Who can participate: Adults scheduled for planned robot-assisted surgery on the upper urinary tract. Participants must be able to give informed consent and can be of any gender.

Who cannot participate: Patients with cancer or tumors in the kidney or ureter, those with kidney stones, or individuals with renal reflux are excluded from this study.

What the trial involves: The study compares different pain relief methods during and after surgery. Patients will receive one of several treatments: spinal morphine (injected into the spinal fluid), intravenous lidocaine (given through a vein), or a combination of bupivacaine and adrenaline. The goal is to determine which approach best improves recovery after surgery, as measured by the Quality of Recovery 15 scale. Recovery progress, including pain levels and overall well-being, will be monitored at various points after surgery.

Medications being tested: The trial uses three main medications: bupivacaine (a local anesthetic to numb the surgical area), morphine (a strong pain reliever administered into the spinal space), and lidocaine (a local anesthetic given through a vein).

Study on the Effect of Furosemide and Amiloride Hydrochloride on Kidney Stone Fragments After Laser Treatment in Patients Undergoing Flexible Ureteroscopy

This French trial investigates whether furosemide can help patients become stone-free after a procedure that uses a laser to break down kidney stones.

Who can participate: Men and women aged 18 to 79 years who need flexible ureteroscopy to remove kidney stones smaller than 3 centimeters. Participants must be part of the French social security system, provide written consent, and be able to follow study requirements.

Who cannot participate: Patients outside the specified age range, those with medical conditions unrelated to kidney stone treatment, members of vulnerable populations, and individuals with health issues that might interfere with the study are excluded.

What the trial involves: After undergoing flexible ureteroscopy with laser treatment, participants will receive either 40 mg of furosemide through a slow intravenous injection or a placebo. The study will monitor the stone-free rate three months after the procedure using a low-dose CT scan. Researchers will also assess post-operative urinary tract infections, pain levels, and any adverse events related to the medication.

Medication being tested: Furosemide, a medication administered through slow intravenous injection, is being studied to determine if it can help clear remaining stone fragments more effectively after laser treatment.

Evaluation of tamsulosin and furosemide combination therapy after shock wave lithotripsy in patients with kidney stones

This Danish trial evaluates whether combining tamsulosin and furosemide can help patients pass stone fragments more effectively after shock wave lithotripsy.

Who can participate: Adults aged 18 years or older with kidney stones or stones in the upper ureter that are smaller than 2 centimeters. Participants must understand study procedures, be willing to provide signed consent, and not belong to vulnerable population groups.

Who cannot participate: The trial excludes patients under 18, those with known allergies to tamsulosin or furosemide, pregnant or breastfeeding women, individuals with severe kidney or liver disease, patients with low blood pressure, those taking medications that could interact with study drugs, patients with active urinary tract infections, individuals with bleeding disorders, those who cannot follow study procedures, patients who have had unsuccessful previous shock wave treatment, those with stones larger than 2 centimeters, and individuals with other serious medical conditions.

What the trial involves: After receiving shock wave lithotripsy treatment, patients will take a combination of tamsulosin (which relaxes urinary tract muscles) and furosemide (which increases urine production) for four weeks. The study will monitor how well stones are cleared and assess pain levels. Success will be determined by the absence of stones or the presence of only very small fragments (less than 3 millimeters) after four weeks of treatment.

Medications being tested: Tamsulosin helps relax muscles in the urinary tract to make it easier for stone fragments to pass. Furosemide is a diuretic that increases urine production to help flush out stone fragments. Pain medications (ibuprofen and paracetamol) may be used as needed.

Study of tamsulosin and furosemide combination therapy for patients after shock wave lithotripsy of kidney stones

This Danish study investigates the same medication combination as the previous trial but represents a separate research effort examining whether tamsulosin and furosemide together can improve outcomes after shock wave lithotripsy.

Who can participate: Adults at least 18 years old with kidney stones or stones in the upper ureter smaller than 2 centimeters. Participants must understand study procedures, sign an informed consent form, be able to follow study instructions and attend follow-up visits, and not belong to vulnerable population groups.

Who cannot participate: The trial excludes patients under 18, pregnant or breastfeeding women, those with known allergies to tamsulosin or furosemide, individuals with severe kidney or liver disease, patients with uncontrolled blood pressure or history of fainting when standing up quickly, those currently using other alpha-blocker medications, patients with active urinary tract infections, individuals with blood clotting disorders or severe heart conditions, those unable to provide informed consent, people with mental conditions affecting study compliance, patients currently in other clinical trials, and individuals with previous adverse reactions to similar medications.

What the trial involves: Following shock wave lithotripsy, patients will receive a combination of tamsulosin and furosemide for several weeks. The study will examine whether this combination improves the success rate of stone removal and reduces the need for additional treatments. Researchers will also monitor pain levels throughout the treatment period. Success will be measured by checking if all stone fragments have been cleared from the urinary system.

Medications being tested: Tamsulosin relaxes urinary tract muscles to ease stone passage, while furosemide increases urine production to help flush out fragments. Additional pain relief with ibuprofen or paracetamol may be provided as needed.

Summary

The four ongoing trials for nephrolithiasis represent diverse approaches to improving patient outcomes. Two trials are taking place in Denmark, both examining the same medication combination (tamsulosin and furosemide) after shock wave lithotripsy. This concentration suggests significant interest in determining whether these medications can help patients pass stone fragments more effectively after this common procedure.

The trials span three European countries, with France and Sweden each hosting one study. The French trial focuses on furosemide alone after laser treatment, while the Swedish trial takes a different approach by examining pain management strategies during robot-assisted surgery.

A notable pattern is the focus on post-procedure medication support. Three of the four trials investigate medications to help clear stone fragments after treatment, whether through flexible ureteroscopy or shock wave lithotripsy. This emphasis reflects the medical community’s interest in improving stone clearance rates and reducing the need for repeat procedures.

The medications under investigation include furosemide, tamsulosin, morphine, lidocaine, and bupivacaine, with furosemide appearing in three of the four trials. This suggests that researchers are particularly interested in whether increasing urine production can improve outcomes for patients.

Ongoing Clinical Trials on Nephrolithiasis

  • Evaluation of tamsulosin and furosemide combination therapy after shock wave lithotripsy in patients with kidney stones

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Denmark
  • Study of tamsulosin and furosemide combination therapy for patients after shock wave lithotripsy of kidney stones

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Denmark