COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI

• Sponsor: Armed Forces Institute of Urology, Rawalpindi (Other)
• Overall Status: Completed
• CT.gov ID: NCT05790902
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 24

Study Details

Study Description

Brief Summary

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.

Condition or Disease	Intervention/Treatment	Phase
Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi	Drug: Silodosin; Drug: Tamsulosin	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
• Actual Study Start Date: Sep 1, 2022
• Actual Primary Completion Date: Feb 28, 2023
• Actual Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silodosin Group The patients used Silodosin for ureteric calculi	Drug: Silodosin; The patients used Silodosin for Medical expulsive therapy of ureteric calculi
Experimental: Tamsulosin Group The patients used Tamsulosin for ureteric calculi	Drug: Tamsulosin; The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi

Outcome Measures

Primary Outcome Measures

1. Stone clearance rate [upto 4 weeks]

   Stone clearance rate

Secondary Outcome Measures

1. Stone expulsion time [upto 4 weeks]

   Stone expulsion time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AFIU Rawalpindi	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

• Armed Forces Institute of Urology, Rawalpindi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AJ Arif, DR ABDUL JABBAR ARIF, Armed Forces Institute of Urology, Rawalpindi
• ClinicalTrials.gov Identifier: NCT05790902
• Other Study ID Numbers: AFIU-2022-02
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi; Tamsulosin; Silodosin

Study Results

No Results Posted as of Mar 30, 2023