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NCT05032287 Clinical Trial

Medical Expulsive Therapy Post-SWL For Renal Stones

Urolithiasis Clinical Trial

Official title:
Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05032287
Other study ID # MET SWL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 1, 2020

Study information
Verified date August 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Renal stone = 20 mm. - Lower calyceal stone = 15 mm Exclusion Criteria: - Women with known or suspected pregnancy or breastfeeding. - History of alpa-blockers (more than 7 days prior to study participation) - History of ureteral stricture - Multiple (that is more than 2) stones - Stone in solitary kidney (either anatomically or functionally). - Presence of urinary sepsis. - Estimated glomerular filtration rate < 30 ml/min - Contraindication or allergy to tamsulosin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tamsulosin
Tamsulosin 0.4 mg once daily
• Placebo
Placebo once daily

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansourah Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stone free rate defined as patient free of any stone residual assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT) at 3 months
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