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

Primary Purpose

Lower Ureteric Stones

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tadalafil versus tamsulosin as MET
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Ureteric Stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed Saleh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tamsulosin treated group

Tadalafil treated group

Arm Description

83 patient with lower ureteric stone will take tamsulosin 0.4 mg once daily .Therapy will be given for a maximum of 4 weeks.

83 patients with lower ureteric stone will take tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.

Outcomes

Primary Outcome Measures

Lower ureteric stone expulsion
Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
March 3, 2022
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04641507
Brief Title
Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones
Official Title
Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Ureteric Stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin treated group
Arm Type
Active Comparator
Arm Description
83 patient with lower ureteric stone will take tamsulosin 0.4 mg once daily .Therapy will be given for a maximum of 4 weeks.
Arm Title
Tadalafil treated group
Arm Type
Active Comparator
Arm Description
83 patients with lower ureteric stone will take tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Tadalafil versus tamsulosin as MET
Intervention Description
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 Measure Information:
Title
Lower ureteric stone expulsion
Description
Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Masoud, Doctorate
Organizational Affiliation
Head of urology department
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Saleh
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
17102958
Citation
Gratzke C, Uckert S, Kedia G, Reich O, Schlenker B, Seitz M, Becker AJ, Stief CG. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res. 2007 Feb;35(1):49-54. doi: 10.1007/s00240-006-0073-1. Epub 2006 Nov 11.
Results Reference
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PubMed Identifier
22297243
Citation
Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.
Results Reference
background
PubMed Identifier
28593477
Citation
Pietropaolo A, Proietti S, Geraghty R, Skolarikos A, Papatsoris A, Liatsikos E, Somani BK. Trends of 'urolithiasis: interventions, simulation, and laser technology' over the last 16 years (2000-2015) as published in the literature (PubMed): a systematic review from European section of Uro-technology (ESUT). World J Urol. 2017 Nov;35(11):1651-1658. doi: 10.1007/s00345-017-2055-z. Epub 2017 Jun 7.
Results Reference
background
PubMed Identifier
19560860
Citation
Seitz C, Liatsikos E, Porpiglia F, Tiselius HG, Zwergel U. Medical therapy to facilitate the passage of stones: what is the evidence? Eur Urol. 2009 Sep;56(3):455-71. doi: 10.1016/j.eururo.2009.06.012. Epub 2009 Jun 21.
Results Reference
background
PubMed Identifier
17070333
Citation
Shabsigh R, Seftel AD, Rosen RC, Porst H, Ahuja S, Deeley MC, Garcia CS, Giuliano F. Review of time of onset and duration of clinical efficacy of phosphodiesterase type 5 inhibitors in treatment of erectile dysfunction. Urology. 2006 Oct;68(4):689-96. doi: 10.1016/j.urology.2006.05.009. No abstract available.
Results Reference
background
PubMed Identifier
27521691
Citation
Tasian GE, Kabarriti AE, Kalmus A, Furth SL. Kidney Stone Recurrence among Children and Adolescents. J Urol. 2017 Jan;197(1):246-252. doi: 10.1016/j.juro.2016.07.090. Epub 2016 Aug 10.
Results Reference
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Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones

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