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Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641507
Recruitment Status : Active, not recruiting
First Posted : November 23, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Ahmed Saleh Mostafa, Beni-Suef University

Brief Summary:
The aim of the work is to compare the efficacy of tadalafil and tamsulosin as a medical expulsive therapy for lower ureteric stones

Condition or disease Intervention/treatment Phase
Lower Ureteric Stones Drug: Tadalafil versus tamsulosin as MET Phase 4

Detailed Description:

Gradually increasing incidence rate of kidney stone is a significant concern of medical world. Genetics and/or life style accelerate the kidney stone formation (Urolithiasis). Sometimes, it is stuck up in ureter especially distal ureter; hence called as lower ureteral stone (LUS) and causes intense flank pain beside urinary obstruction.

The ureter contains α adrenergic receptors along its entire length with the highest concentration in the distal ureter.

There has been a steep rise in minimally invasive procedures but medical expulsive therapy (MET) is still regarded as an established treatment option for the management of distal ureteric stones.

Stone location, size, number, ureteric spasm, mucosal oedema or inflammation, and ureteric anatomy are the factors affecting passage of ureteric stones.

Drugs that expel stones might act by relaxing ureteral smooth muscle through inhibition of calcium channel pumps or α-1 receptor blockade. Tamsulosin is one of the most commonly used α-blockers.

Phosphodiesterase inhibitors (PDEi) are a class of drugs that inhibit the breakdown of cAMP and cGMP, enhancing smooth muscle relaxation. Therefore, PDEi may be able to decrease ureteral spasm and facilitate stone passage. Tadalafil is a selective PDE5i and because of its smooth muscle relaxation property, tadalafil received the US Food and Drug Administration approval for lower urinary tract symptoms with benign prostatic hyperplasia and erectile dysfunction.

Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms had already been demonstrated .

With demonstration of in vitro effects of phosphodiesterase-5 inhibitor (PDE5i) as tadalafil on isolated human ureteral smooth muscle, interest in use of PDE5i as MET has increased.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : March 3, 2022
Estimated Study Completion Date : March 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tamsulosin treated group
83 patient with lower ureteric stone will take tamsulosin 0.4 mg once daily .Therapy will be given for a maximum of 4 weeks.
Drug: Tadalafil versus tamsulosin as MET
166 patients with lower ureteric stone will be randomaized using computer-based randomization charts equally into 83 patients (Group A) treatment with tamsulosin 0.4 mg once daily or 83 patients (Group B) treatment with tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.

Active Comparator: Tadalafil treated group
83 patients with lower ureteric stone will take tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.
Drug: Tadalafil versus tamsulosin as MET
166 patients with lower ureteric stone will be randomaized using computer-based randomization charts equally into 83 patients (Group A) treatment with tamsulosin 0.4 mg once daily or 83 patients (Group B) treatment with tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.




Primary Outcome Measures :
  1. Lower ureteric stone expulsion [ Time Frame: 4 weeks ]
    Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years
  • Patient have a distal ureteric stone of 5-9 mm in greatest dimension
  • Patient diagnosed by ultrasonography of the kidney, ureter, and bladder , X-ray KUB and noncontrast computed tomography scan.

Exclusion Criteria:

  • Pregnant or lactating mothers.
  • Patients have UTI.
  • Patients have severe hydroureteronephrosis.
  • Patients have multiple ureteric stones.
  • Patients have solitary kidney.
  • Patients have acute or chronic renal failure.
  • Patients have previous therapies for the stone.
  • Patients with history of open surgery/endoscopic interventions.
  • Patients have ureteric strictures.
  • Patients take concomitant treatment with calcium antagonists, β-blockers, corticosteroids or nitrates.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641507


Locations
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Egypt
Ahmed Saleh
Giza, Egypt
Sponsors and Collaborators
Beni-Suef University
Investigators
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Study Chair: Amr Masoud, Doctorate Head of urology department
Publications:

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Responsible Party: Ahmed Saleh Mostafa, Urology specialist, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04641507    
Other Study ID Numbers: FMBSUREC/30042019/Saleh
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Tadalafil
Tamsulosin
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs