NCT04641507

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

November 18, 2020

Last Update Submit

March 3, 2022

Conditions

Lower Ureteric Stones

Outcome Measures

Primary Outcomes (1)

  • Lower ureteric stone expulsion

    Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin

    4 weeks

Study Arms (2)

Tamsulosin treated group

ACTIVE COMPARATOR

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

Tadalafil treated group

ACTIVE COMPARATOR

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

Interventions

Tadalafil versus tamsulosin as METDRUG

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.

Tadalafil treated groupTamsulosin treated group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Saleh

Giza, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 17102958BACKGROUND

  • 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.

    PMID: 22297243BACKGROUND

  • 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.

    PMID: 28593477BACKGROUND

  • 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.

    PMID: 19560860BACKGROUND

  • 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.

    PMID: 17070333BACKGROUND

  • 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.

    PMID: 27521691BACKGROUND

Study Officials

  • Amr Masoud, Doctorate

    Head of urology department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology specialist

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 23, 2020

Study Start

January 1, 2020

Primary Completion

March 3, 2022

Study Completion

March 5, 2022

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations

EG(1)