Back to resultsCOMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Primary Purpose
Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Silodosin
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
Eligibility Criteria
Inclusion Criteria: symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of <10 mm in size (on plain CT KUB) Exclusion Criteria: solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
Sites / Locations
- AFIU Rawalpindi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Silodosin Group
Tamsulosin Group
Arm Description
The patients used Silodosin for ureteric calculi
The patients used Tamsulosin for ureteric calculi
Outcomes
Primary Outcome Measures
Stone clearance rate
Stone clearance rate
Secondary Outcome Measures
Stone expulsion time
Stone expulsion time
Full Information
NCT ID
NCT05790902
First Posted
March 17, 2023
Last Updated
March 17, 2023
Sponsor
Armed Forces Institute of Urology, Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT05790902
Brief Title
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Official Title
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Urology, Rawalpindi
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 compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.
Detailed Description
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silodosin Group
Arm Type
Experimental
Arm Description
The patients used Silodosin for ureteric calculi
Arm Title
Tamsulosin Group
Arm Type
Experimental
Arm Description
The patients used Tamsulosin for ureteric calculi
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
The patients used Silodosin for Medical expulsive therapy of ureteric calculi
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi
Primary Outcome Measure Information:
Title
Stone clearance rate
Description
Stone clearance rate
Time Frame
upto 4 weeks
Secondary Outcome Measure Information:
Title
Stone expulsion time
Description
Stone expulsion time
Time Frame
upto 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of <10 mm in size (on plain CT KUB)
Exclusion Criteria:
solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
Facility Information:
Facility Name
AFIU Rawalpindi
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
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