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Study of tamsulosin and furosemide combination therapy for patients after shock wave lithotripsy of 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 who have undergone shock wave lithotripsy, a procedure used to break up kidney stones. The treatment involves using a combination of medications: tamsulosin (a medication that relaxes certain muscles in the urinary tract) and furosemide (a water pill that increases urine production). These medications are being tested to see if they can help patients pass stone fragments more effectively after the procedure.

The research aims to determine if using these medications together can improve the success rate of kidney stone removal and reduce the need for additional treatments. The study will also examine how this combination of medicines affects pain levels that patients experience. During the study, some patients may receive ibuprofen or paracetamol for pain relief as needed.

The treatment period lasts for several weeks after the shock wave lithotripsy procedure. Patients will be monitored to check how well they are passing the stone fragments and to assess their comfort levels. The success of the treatment will be determined by checking if all stone fragments have been cleared from the urinary system.

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 phase

    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 ESWL session, your pain levels will be measured using a visual pain scale.

    You will be given medications to take after the procedure: tamsulosin (0.4 mg prolonged-release tablet), furosemide (20 mg tablet), ibuprofen (400 mg tablet) for pain relief, and paracetamol (500 mg tablet) if needed for additional pain control.

  2. Step 2

    Two-week monitoring period

    You will continue taking the prescribed medications for two weeks after the ESWL procedure.

    During this period, your pain levels will be regularly assessed using the visual pain scale.

    The medications help with stone fragment passage and pain management.

  3. Step 3

    Second ESWL session

    If needed, you will undergo a second ESWL session.

    Pain assessment will be conducted during this procedure using the same visual pain scale.

    The medication regimen will continue as prescribed.

  4. Step 4

    Final evaluation

    Four weeks after your last ESWL treatment, you will undergo a CT scan without contrast.

    The scan will check if you are stone-free or if any remaining fragments are smaller than 3 millimeters.

    This final evaluation will determine the success of your treatment.

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have kidney stones or stones in the upper part of the ureter (the tube connecting kidney to bladder) that are smaller than 2 centimeters
  • Must be able to understand the study procedures
  • Must be willing to sign an informed consent form
  • Can be either male or female
  • Must be able to follow study instructions and attend follow-up visits
  • Must not belong to any vulnerable population groups (such as prisoners, mentally disabled persons, or others unable to give informed consent)

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Pregnancy or breastfeeding
  • Known allergy or hypersensitivity to Tamsulosin (medication that relaxes muscles in the prostate and bladder) or Furosemid (water pill that helps remove excess fluid)
  • Severe kidney disease or kidney failure
  • Severe liver disease
  • Uncontrolled blood pressure
  • History of fainting when standing up quickly
  • Current use of other alpha-blocker medications
  • Active urinary tract infection
  • Blood clotting disorders
  • Severe heart conditions
  • Unable to provide informed consent
  • Mental conditions that may affect compliance with the study protocol
  • Current participation in other clinical trials
  • Previous adverse reactions to similar medications
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Investigated drugs

Tamsulosin is an alpha-blocker medication that helps relax the muscles in the urinary tract. This makes it easier for stone fragments to pass through the urinary system after kidney stone treatment. It can help reduce pain and discomfort during the stone passage process. Furosemide is a diuretic medication (also known as a "water pill") that increases urine production. By increasing urine flow, it may help flush out kidney stone fragments more effectively after treatment. This medication helps the body remove excess water and salt through urination. Shock Wave Lithotripsy (ESWL) is a non-medication treatment that uses sound waves to break kidney stones into smaller pieces. This makes the stones easier to pass naturally through urination. It's a non-surgical procedure performed from outside the body.

What is already known about the treatment

  • Tamsulosin

    An alpha-blocker medication taken orally that relaxes smooth muscle in the urinary tract and prostate, making it easier for stone fragments to pass through the urinary system after kidney stone treatment. This medication works by blocking alpha-1 receptors in the ureter and bladder neck, which reduces muscle tension and allows for better urine flow. Tamsulosin is commonly used in medical expulsive therapy and is particularly effective when combined with shock wave lithotripsy for kidney stone treatment.

  • Furosemide

    A potent loop diuretic medication administered orally or by injection that increases urine production by preventing salt and fluid reabsorption in the kidneys. This medication works by inhibiting the sodium-potassium-chloride cotransporter in the ascending loop of Henle, leading to increased urine output which can help flush out kidney stone fragments. Furosemide is widely used in clinical practice for various conditions requiring enhanced urinary output and is particularly useful in supporting kidney stone clearance after lithotripsy procedures.

Investigated diseases

Kidney Stones - A condition where hard deposits made of minerals and salts form inside the kidneys. These stones can vary in size from tiny crystals to large stone-like masses. The stones develop when certain substances become concentrated enough in the urine to form crystals. Over time, these crystals can grow larger and form solid deposits. When stones move through the urinary tract, they can cause severe pain, especially in the back and side. Some stones may be small enough to pass naturally, while others can grow large enough to block the flow of urine. Note: Based on the provided trial data, this is the primary medical condition being studied, as the trial focuses on therapy after shock wave lithotripsy of kidney stones.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510792-38-00Estimated enrolment500 patientsSponsorRegion Midtjylland

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