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CompletedNCT05790902Updated Mar 30, 2023

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

A Phase 1 interventional study of Silodosin and Tamsulosin in Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi, sponsored by Armed Forces Institute of Urology, Rawalpindi. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Armed Forces Institute of Urology, Rawalpindi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2022, registered Mar 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi

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03

In context

Calculi

51 studies on the registry are indexed under Calculi; 6 are open to participants now.

This study's enrollment of 142 is above the median of 74 across 43 interventional studies indexed under Calculi.

Browse Calculi studies →

Lead sponsor

Armed Forces Institute of Urology, Rawalpindi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of \<10 mm in size (on plain CT KUB)

Exclusion criteria

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,
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    Silodosin Group

    The patients used Silodosin for ureteric calculi

    Drug: Silodosin

  • Experimental
    Tamsulosin Group

    The patients used Tamsulosin for ureteric calculi

    Drug: Tamsulosin

Interventions

  • The patients used Silodosin for Medical expulsive therapy of ureteric calculi

  • The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi

06

What researchers measure

Primary outcomes

  1. Stone clearance rate

    Stone clearance rate

    Time frame: upto 4 weeks

Secondary outcomes

  1. Stone expulsion time

    Stone expulsion time

    Time frame: upto 4 weeks

07

Study locations

1 site
  • AFIU Rawalpindi
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Feb 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2023
First posted
Mar 30, 2023
StartActual
Sep 1, 2022
Primary completionActual
Feb 28, 2023
CompletionActual
Feb 28, 2023
Last update
Mar 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05790902
Lead sponsor
Armed Forces Institute of Urology, Rawalpindi
Responsible party
AJ Arif (DR ABDUL JABBAR ARIF, Armed Forces Institute of Urology, Rawalpindi) — Principal investigator
First posted
Mar 30, 2023
Start date
Sep 1, 2022
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Last update
Mar 30, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Silodosin · Tamsulosin

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