Back to resultsMedical Expulsive Therapy Post-SWL For Renal Stones
Primary Purpose
Urologic Diseases, Urolithiasis, Stone, Kidney
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases
Eligibility Criteria
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
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
tamsulosin
Placeb
Arm Description
tamsulosin 0.4 mg once daily
Placebo once daily
Outcomes
Primary Outcome Measures
Stone free rate defined as patient free of any stone residual
assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05032287
Brief Title
Medical Expulsive Therapy Post-SWL For Renal Stones
Official Title
Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Urolithiasis, Stone, Kidney
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tamsulosin
Arm Type
Active Comparator
Arm Description
tamsulosin 0.4 mg once daily
Arm Title
Placeb
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Tamsulosin 0.4 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Stone free rate defined as patient free of any stone residual
Description
assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansourah
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Medical Expulsive Therapy Post-SWL For Renal Stones
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