Medical Expulsive Therapy Post-SWL For Renal Stones

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

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

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Urolithiasis; Stone, Kidney
• Intervention / Treatment: Drug: Placebo; Drug: Tamsulosin

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aldakahlia
    • Mansourah, Aldakahlia, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tamsulosin; tamsulosin 0.4 mg once daily	Drug: Tamsulosin; Tamsulosin 0.4 mg once daily
Placebo Comparator: Placeb; Placebo once daily	Drug: Placebo; Placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Calculi; Urolithiasis; Kidney Calculi; Nephrolithiasis; Urologic Diseases; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: MET SWL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No