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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with kidney stones who have undergone shock wave lithotripsy, a procedure that breaks down stones into smaller fragments. The research aims to evaluate the effectiveness of combining two medications: tamsulosin (a medication that relaxes certain muscles in the urinary system) and furosemide (a water pill that increases urine production) to help remove stone fragments after the procedure.

The treatment involves taking oral medications for four weeks after the stone-breaking procedure. During this time, patients will receive either a combination of tamsulosin and furosemide, or standard pain relief medications including ibuprofen and paracetamol. The study will monitor how well the stones are cleared from the urinary system and assess the level of pain experienced by patients.

The research will use special imaging techniques to check if the stone fragments have been successfully cleared from the kidney and urinary tract. The success of the treatment will be determined by the absence of stones or the presence of only very small fragments (less than 3 millimeters in size) after four weeks of treatment. The study will also track how much pain medication patients need during and after the procedure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    You will receive shock wave lithotripsy (ESWL) treatment for your kidney stones. This is a procedure that uses shock waves to break kidney stones into smaller pieces.

    During the procedure, your pain levels will be monitored using a pain scale.

  2. Step 2

    Medication regimen

    You will receive two main medications:

    - Tamsulosin (0.4 mg prolonged-release tablet) taken by mouth

    - Furosemide (20 mg tablet) taken by mouth

    For pain management, if needed:

    - Ibuprofen (400 mg film-coated tablet) taken by mouth

    - Paracetamol (500 mg film-coated tablet) taken by mouth

  3. Step 3

    Second ESWL session

    A second shock wave lithotripsy session will be performed if needed.

    Your pain levels will be monitored again during this procedure.

  4. Step 4

    Follow-up period

    Your pain levels will be monitored for 2 weeks after the last procedure.

    Four weeks after your last treatment, you will have a CT scan without contrast to check if:

    - All stones have been cleared, or

    - Any remaining stone fragments are smaller than 3 millimeters

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have kidney stones or stones located in the upper part of the ureter (the tube connecting kidney to bladder)
  • The stone size must be less than 2 centimeters in diameter
  • Must be able to understand the study procedures
  • Must be willing and able to provide signed informed consent
  • Can be either male or female
  • Must not be part of any vulnerable population groups (such as prisoners, mentally disabled persons, or other protected groups)

Who cannot join the trial?

13 criteria

  • Patients under 18 years old cannot participate in the study
  • Patients with known allergies or hypersensitivity to Tamsulosin (a medication that helps relax certain muscles) or Furosemid (a water pill that helps remove excess fluid)
  • Pregnant or breastfeeding women
  • Patients with severe kidney function problems
  • Patients with severe liver disease
  • Patients with low blood pressure (hypotension)
  • Patients currently taking medications that could interact with the study drugs
  • Patients with active urinary tract infection
  • Patients with bleeding disorders
  • Patients who cannot follow study procedures or attend follow-up visits
  • Patients who have had previous unsuccessful shock wave lithotripsy (a procedure that uses sound waves to break kidney stones into small pieces)
  • Patients with stones larger than 2 centimeters
  • Patients with other serious medical conditions that could interfere with the study treatment
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Investigated drugs

Tamsulosin This medication is an alpha-blocker that helps relax certain muscles in the urinary tract. It makes it easier for stone fragments to pass through the urinary system after kidney stone treatment. This medication can help reduce the discomfort and pain associated with passing kidney stones. Furosemide This is a diuretic medication (also known as a "water pill") that increases urine production. By increasing urine flow, it can help flush out kidney stone fragments more effectively after treatment. It works by making your kidneys release more water and salt into your urine. Shock Wave Lithotripsy (SWL) This is not a medication but a treatment procedure that uses shock waves to break kidney stones into smaller pieces. The smaller fragments can then pass more easily through the urinary tract. This treatment is performed from outside the body and doesn't require surgical incisions.

What is already known about the treatment

  • Tamsulosin

    An alpha-blocker medication that is taken orally in capsule form, primarily used to help pass kidney stones and treat symptoms of benign prostatic hyperplasia. It works by relaxing smooth muscle in the urinary tract and prostate, making it easier for stone fragments to pass through the ureter and improving urinary flow. This medication belongs to the class of alpha-1 adrenergic blockers and is commonly used in medical expulsive therapy following shock wave lithotripsy procedures.

  • Furosemide

    A potent loop diuretic medication administered orally or by injection, used to increase urine production and help eliminate excess fluid from the body. In kidney stone treatment, it helps create a stronger urinary flow that can assist in passing stone fragments after lithotripsy procedures. This medication works by inhibiting the reabsorption of sodium and chloride in the kidney tubules, belongs to the loop diuretic class, and is frequently used in combination with other medications for enhanced stone clearance.

Investigated diseases

Kidney Stone Disease - A condition where solid masses form in the kidneys from minerals and salts in urine. These stones can vary in size from tiny crystals to larger stone-like formations. They develop when the urine becomes too concentrated, allowing minerals to crystallize and stick together. The stones can remain in the kidneys or travel down the urinary tract. When stones move through the urinary system, they may cause discomfort or pain. The condition can affect people of any age, though it tends to occur more frequently in adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510792-38-01Estimated enrolment420 patientsSponsorRegion Midtjylland

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