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

March 3, 2022 updated by: Ahmed Saleh Mostafa, Beni-Suef University
The aim of the work is to compare the efficacy of tadalafil and tamsulosin as a medical expulsive therapy for lower ureteric stones

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Ahmed Saleh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower ureteric stone expulsion
Time Frame: 4 weeks
Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Chair: Amr Masoud, Doctorate, Head of urology department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 3, 2022

Study Completion (Anticipated)

March 5, 2022

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/30042019/Saleh

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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