Medical Expulsive Therapy Post-SWL For Renal Stones

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05032287
• Collaborator: (none)
• Enrollment: 235
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 29.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases; Urolithiasis; Stone, Kidney	Drug: Tamsulosin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center	Mansourah	Aldakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT05032287
• Other Study ID Numbers: MET SWL
• First Posted: Sep 2, 2021
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urolithiasis; Kidney Calculi; Nephrolithiasis; Urologic Diseases; Tamsulosin

Study Results

No Results Posted as of Sep 2, 2021