Medical Expulsive Therapy Post-SWL For Renal Stones

Not Applicable

Completed

• Conditions: Urologic Diseases; Urolithiasis; Stone, Kidney
• Interventions: Drug: Tamsulosin; Drug: Placebo

• Registration Number: NCT05032287
• Lead Sponsor: Mansoura University

Brief 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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-30
• Last Update Submitted: 2021-08-30
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• Renal stone ≤ 20 mm.
• Lower calyceal stone ≤ 15 mm

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamsulosin	Tamsulosin	tamsulosin 0.4 mg once daily
Placeb	Placebo	Placebo once daily

Primary Outcome Measures

Name	Time	Method
Stone free rate defined as patient free of any stone residual	at 3 months	assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansourah, Aldakahlia, Egypt